Page last updated: 2024-11-08

cannabidiol

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Description

Cannabidiol: Compound isolated from Cannabis sativa extract. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

cannabidiol : An cannabinoid that is cyclohexene which is substituted by a methyl group at position 1, a 2,6-dihydroxy-4-pentylphenyl group at position 3, and a prop-1-en-2-yl group at position 4. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

FloraRankFlora DefinitionFamilyFamily Definition
CannabisgenusThe plant genus in the Cannabaceae plant family, Urticales order, Hamamelidae subclass. The flowering tops are called many slang terms including pot, marijuana, hashish, bhang, and ganja. The stem is an important source of hemp fiber.[MeSH]CannabaceaeA plant family of the order Urticales, subclass Hamamelidae, class Magnoliopsida. It is most notable for the members, Cannabis and Hops.[MeSH]
Cannabis sativaspecies[no description available]CannabaceaeA plant family of the order Urticales, subclass Hamamelidae, class Magnoliopsida. It is most notable for the members, Cannabis and Hops.[MeSH]

Cross-References

ID SourceID
PubMed CID644019
CHEMBL ID190461
CHEBI ID69478
SCHEMBL ID119679
MeSH IDM0003266

Synonyms (96)

Synonym
cannabidiol (7ci)
2-[3-methyl-6-(methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol
d1(2)-trans-cannabidiol
(3r,4r)-2-p-mentha-1,8-dien-3-yl-5-pentylresorcinol
(-)-cannabidiol
resorcinol, 2-p-mentha-1,8-dien-3-yl-5-pentyl-, trans-(-)- (8ci)
(-)-trans-cannabidiol
(-)-trans-2-p-mentha-1,8-dien-3-yl-5-pentylresorcinol
1,3-benzenediol, 2-[(1r,6r)-3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-
resorcinol, 2-p-mentha-1,8-dien-3-yl-5-pentyl-, (-)-(e)-
cannabidiol
C07578
13956-29-1
CBD ,
2-(3-methyl-6-prop-1-en-2-yl-1-cyclohex-2-enyl)-5-pentyl-benzene-1,3-diol
2-[1r-3-methyl-6r-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol
epidiolex
bdbm50121429
2-(6-isopropenyl-3-methyl-cyclohex-2-enyl)-5-pentyl-benzene-1,3-diol (cannabidiol)
2-[(1r,6r)-3-methyl-6-prop-1-en-2-ylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol
chebi:69478 ,
(-)-cbd
gwp-42003-p
.delta.1(2)-trans-cannabidiol
cardiolrx
btx-1204
gwp42003
gwp42003-p
gwp-42003
btx-1503
CHEMBL190461 ,
2-((1r,6r)-6-isopropenyl-3-methyl-cyclohex-2-enyl)-5-pentyl-benzene-1,3-diol
bdbm50318484
19gbj60sn5 ,
zyn002
unii-19gbj60sn5
cannabidiol [usan]
delta1(2)-trans-cannabidiol
cannabidiolum
delta(1(2))-trans-cannabidiol
(1'r,2'r)-5'-methyl-4-pentyl-2'-(prop-1-en-2-yl)-1',2',3',4'-tetrahydrobiphenyl-2,6-diol
sativex (cbd + thc, fixed-dose oral spray)
2-[(1r,6r)-3-methyl-6-prop-1-en-2-yl-1-cyclohex-2-enyl]-5-pentylbenzene-1,3-diol
gtpl4150
nabiximols (cbd + thc, fixed-dose oral spray)
2-((1r,6r)-3-methyl-6-(prop-1-en-2-yl)cyclohex-2-en-1-yl)-5-pentylbenzene-1,3-diol
cannabidiol [who-dd]
cannabidiol [orange book]
cannabidiol [usp-rs]
2-((1r,6r)-3-methyl-6-(1-methylethenyl)cyclohex-2-enyl)-5-pentylbenzene-1,3-diol
cannabidiol [inci]
cannabidiol [mart.]
cannabidiol [inn]
1,3-benzenediol, 2-((1r,6r)-3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-
cannabidiol [mi]
SCHEMBL119679
2-(4-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-1,3-benzenediol trans-
1,3-benzenediol, 2-(4-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, trans-
3556-78-3
resorcinol, 2-p-mentha-1,8-dien-3-yl-5-pentyl-, (+-)-
AC-34022
(-)-cannabidiol 1.0 mg/ml in methanol
epidiolex (tn)
D10915
cannabidiol (usan/inn)
DB09061
AKOS032948358
DTXSID00871959 ,
HB2785
Q422917
p0t ,
(1'R,2'R)-5'-METHYL-4-PENTYL-2'-(PROP-1-EN-2-YL)-1',2',3',4'-TETRAHYDRO-[1,1'-BIPHENYL]-2,6-DIOL
NCGC00386518-01
(-)-cannabidiol (cbd) 100 microg/ml in methanol
(-)-cannabidiol (cbd) 1000 microg/ml in methanol
(1'r,2'r)-5'-methyl-4-pentyl-2'-(prop-1-en-2-yl)-1',2',3',4'-tetrahydro[1,1'-biphenyl]-2,6-diol
(-)-cannabidiol (cbd) 250 microg/ml in acetonitrile
(-)-cannabidiol (synthetic)
DTXSID301038839
(+/-)-cannabidiol
leafpro cbdmed softgels t-fs qd 20
cannabidiol (usp-rs)
1000mg cbd daily support
leafpro cbdmed softgels fs qp 20
sativex (cbd + thc, fixed-doseoral spray)
melody cloverstrip
nanocdb
n03ax24
cannabidiol (mart.)
2000mg cbd daily support
nabiximols (cbd + thc, fixed-doseoral spray)
dtxcid401436151
FS-10329
16 - cannabidiol in supplements
849 - cannabidiol (cbd) in food
cannabidiol, 1mg/ml in methanol

Research Excerpts

Toxicity

Cannabidiol does not exacerbate adverse effects associated with intravenous fentanyl administration. Most acute and prolonged adverse effects of CBD are mild to moderate, with rare serious adverse effects.

ExcerptReferenceRelevance
" Minor adverse events were slightly more frequent and severe during active treatment, and toxicity symptoms, which were generally mild, were more pronounced in the active phase."( Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study.
Gattlen, B; Hagen, U; Heinzel-Gutenbrunner, M; Jobin, P; Reif, M; Schnelle, M; Tschopp, F; Vaney, C, 2004
)
0.32
" The large majority of adverse effects were mild or moderate, and there were no adverse effect-related withdrawals or serious adverse effects in the active treatment group."( Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis.
Blake, DR; Ho, M; Jubb, RW; McCabe, CS; Robson, P, 2006
)
0.33
" A comparative in vivo study in mice has shown HU-331 to be less toxic and more effective than the commonly used doxorubicin."( HU-331: a cannabinoid quinone, with uncommon cytotoxic properties and low toxicity.
Kogan, NM; Peters, M, 2007
)
0.34
" When combined with its ability to target the brain and its lack of toxic side effects, CBD may represent a promising new anti-prion drug."( Nonpsychoactive cannabidiol prevents prion accumulation and protects neurons against prion toxicity.
Chabry, J; Dirikoc, S; Marella, M; Priola, SA; Zsürger, N, 2007
)
0.34
" Cannabidiol, a safe and non-psychotropic ingredient of marijuana, exerts pharmacological effects (e."( Cannabidiol, a safe and non-psychotropic ingredient of the marijuana plant Cannabis sativa, is protective in a murine model of colitis.
Aviello, G; Borrelli, F; Capasso, F; Capasso, R; Di Marzo, V; Guadagno, F; Izzo, AA; Maiello, F; Orlando, P; Petrosino, S; Romano, B, 2009
)
0.35
" Most drug-related adverse events were mild/moderate in severity."( Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain.
Burnell-Nugent, M; Fallon, MT; Ganae-Motan, ED; Johnson, JR; Lossignol, D; Potts, R, 2010
)
0.36
" High numbers of subjects experienced at least one adverse event, but most were mild to moderate in severity and all drug-related serious adverse events resolved."( Meta-analysis of the efficacy and safety of Sativex (nabiximols), on spasticity in people with multiple sclerosis.
Collin, C; Duncombe, P; Stott, C; Wade, DT, 2010
)
0.36
" Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs)."( Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting.
Abanades, S; Arriola, E; Capellà, D; Duran, M; Farré, M; Laporte, JR; Majem, M; Pastor, A; Pérez, E; Rabanal, M; Rams, N; Saura, C; Vidal, X, 2010
)
0.36
" However, little is known about its safety and side effect profile in animals and humans."( Safety and side effects of cannabidiol, a Cannabis sativa constituent.
Bergamaschi, MM; Crippa, JA; Queiroz, RH; Zuardi, AW, 2011
)
0.37
" Furthermore, following withdrawal of Sativex, symptoms often return, but, beyond this, sudden cessation is generally safe with no evidence of physiological or psychological dependence."( Evaluation of the safety and tolerability profile of Sativex: is it reassuring enough?
Wade, D, 2012
)
0.38
" The majority of patients (84%) did not report adverse events."( Long-term effectiveness and safety of nabiximols (tetrahydrocannabinol/cannabidiol oromucosal spray) in clinical practice.
Flachenecker, P; Henze, T; Zettl, UK, 2014
)
0.4
" The primary outcome was the Systematic Assessment for Treatment Emergent Events (SAFTEE) to assess safety and adverse effects."( Safety and pharmacokinetics of oral cannabidiol when administered concomitantly with intravenous fentanyl in humans.
Barnes, AJ; Bergamaschi, MM; Hernandez, S; Huestis, MA; Hurd, YL; Jutras-Aswad, D; Manini, AF; Olmedo, R; Sinha, R; Winkel, G; Yiannoulos, G,
)
0.13
"Cannabidiol does not exacerbate adverse effects associated with intravenous fentanyl administration."( Safety and pharmacokinetics of oral cannabidiol when administered concomitantly with intravenous fentanyl in humans.
Barnes, AJ; Bergamaschi, MM; Hernandez, S; Huestis, MA; Hurd, YL; Jutras-Aswad, D; Manini, AF; Olmedo, R; Sinha, R; Winkel, G; Yiannoulos, G,
)
0.13
" Confusion/ideomotor slowing, fatigue and dizziness were the most frequent side effects; no major adverse events were reported."( Efficacy and safety of nabiximols (Sativex(®)) on multiple sclerosis spasticity in a real-life Italian monocentric study.
Colombo, B; Comi, G; Esposito, F; Ferrè, L; Keller Sarmiento, IJ; Leocani, L; Martinelli Boneschi, F; Martinelli, V; Moiola, L; Nuara, A; Pavan, G; Radaelli, M; Rodegher, M, 2016
)
0.43
" The incidence of adverse events (AEs) was 40."( Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients.
D'Onghia, M; Di Lecce, V; Direnzo, V; Iaffaldano, A; Manni, A; Paolicelli, D; Tortorella, C; Trojano, M; Zoccolella, S, 2016
)
0.43
" The aim of our study was to describe Sativex effectiveness and adverse events profile in a large population of Italian patients with MS in the daily practice setting."( Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity.
Amato, MP; Bergamaschi, R; Bonavita, S; Brescia Morra, V; Bruno Bossio, R; Cavalla, P; Centonze, D; Comi, G; Costantino, GF; Cottone, S; Danni, M; Francia, A; Gajofatto, A; Gasperini, C; Ghezzi, A; Iudice, A; Lus, G; Maniscalco, GT; Marrosu, MG; Matta, M; Messina, S; Mirabella, M; Montanari, E; Patti, F; Pozzilli, C; Rovaris, M; Sessa, E; Solaro, C; Spitaleri, D; Trojano, M; Valentino, P; Zappia, M, 2016
)
0.43
"2%) and/or adverse events (n=268, 18."( Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity.
Amato, MP; Bergamaschi, R; Bonavita, S; Brescia Morra, V; Bruno Bossio, R; Cavalla, P; Centonze, D; Comi, G; Costantino, GF; Cottone, S; Danni, M; Francia, A; Gajofatto, A; Gasperini, C; Ghezzi, A; Iudice, A; Lus, G; Maniscalco, GT; Marrosu, MG; Matta, M; Messina, S; Mirabella, M; Montanari, E; Patti, F; Pozzilli, C; Rovaris, M; Sessa, E; Solaro, C; Spitaleri, D; Trojano, M; Valentino, P; Zappia, M, 2016
)
0.43
"Sativex can be a useful and safe option for patients with MS with moderate to severe spasticity resistant to common antispastic drugs."( Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity.
Amato, MP; Bergamaschi, R; Bonavita, S; Brescia Morra, V; Bruno Bossio, R; Cavalla, P; Centonze, D; Comi, G; Costantino, GF; Cottone, S; Danni, M; Francia, A; Gajofatto, A; Gasperini, C; Ghezzi, A; Iudice, A; Lus, G; Maniscalco, GT; Marrosu, MG; Matta, M; Messina, S; Mirabella, M; Montanari, E; Patti, F; Pozzilli, C; Rovaris, M; Sessa, E; Solaro, C; Spitaleri, D; Trojano, M; Valentino, P; Zappia, M, 2016
)
0.43
"In this study of moderately active Crohn's disease, CBD was safe but had no beneficial effects."( Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial.
Benjaminov, F; Bronshtain, M; Gabay, G; Konikoff, FM; Laish, I; Marii, A; Mechulam, R; Naftali, T; Stein, A, 2017
)
0.46
" Adverse events (AEs) were documented at each visit."( Long-term safety and treatment effects of cannabidiol in children and adults with treatment-resistant epilepsies: Expanded access program results.
Beal, JC; Bebin, EM; Checketts, D; Comi, AM; De Boer, LM; Devinsky, O; Joshi, C; Laux, LC; Lopez, M; Lyons, PD; Patel, AD; Szaflarski, JP; Wechsler, R; Wong, MH; Zentil, PP, 2018
)
0.48
"The objective of this study was to characterize the changes in adverse events, seizure severity, and frequency in response to a pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex®) in a large, prospective, single-center, open-label study."( Cannabidiol improves frequency and severity of seizures and reduces adverse events in an open-label add-on prospective study.
Bebin, EM; Cutter, G; DeWolfe, J; Dure, LS; Gaston, TE; Kankirawatana, P; Liu, Y; Singh, R; Standaert, DG; Szaflarski, JP; Thomas, AE; Ver Hoef, LW, 2018
)
0.48
" Main outcomes included the ≥ 50% reduction in baseline drop and non-drop seizure frequency, and the incidence of treatment withdrawal and adverse events (AEs)."( Efficacy and Safety of Adjunctive Cannabidiol in Patients with Lennox-Gastaut Syndrome: A Systematic Review and Meta-Analysis.
Brigo, F; Cagnetti, C; Lattanzi, S; Silvestrini, M; Trinka, E, 2018
)
0.48
" Main outcomes included the percentage change and the proportion of patients with ≥ 50% reduction in monthly seizure frequency during the treatment period and the incidence of treatment withdrawal and adverse events (AEs)."( Efficacy and Safety of Cannabidiol in Epilepsy: A Systematic Review and Meta-Analysis.
Brigo, F; Cagnetti, C; Del Giovane, C; Lattanzi, S; Silvestrini, M; Trinka, E; Zaccara, G, 2018
)
0.48
" Diaries of seizure frequency and adverse events were reviewed at each visit."( Long-Term Safety, Tolerability, and Efficacy of Cannabidiol in Children with Refractory Epilepsy: Results from an Expanded Access Program in the US.
Caminha Nunes, E; Cilio, MR; Oldham, MS; Rahdari, S; Sands, TT; Tilton, N, 2019
)
0.51
" Adverse events were reported in 21 patients (80."( Long-Term Safety, Tolerability, and Efficacy of Cannabidiol in Children with Refractory Epilepsy: Results from an Expanded Access Program in the US.
Caminha Nunes, E; Cilio, MR; Oldham, MS; Rahdari, S; Sands, TT; Tilton, N, 2019
)
0.51
"8% had adverse events, including 23."( Long-Term Safety, Tolerability, and Efficacy of Cannabidiol in Children with Refractory Epilepsy: Results from an Expanded Access Program in the US.
Caminha Nunes, E; Cilio, MR; Oldham, MS; Rahdari, S; Sands, TT; Tilton, N, 2019
)
0.51
" No serious adverse effects occurred."( Safety and efficacy of nabiximols on spasticity symptoms in patients with motor neuron disease (CANALS): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial.
Comi, G; Comola, M; Falzone, Y; Fazio, R; Ferraro, OE; Leocani, L; Lunetta, C; Mora, G; Riva, N; Sorarù, G, 2019
)
0.51
" Before planning large interventional studies, it is important to ensure that cannabis taken orally is safe and well tolerated in people living with HIV."( Oral cannabinoids in people living with HIV on effective antiretroviral therapy: CTN PT028-study protocol for a pilot randomised trial to assess safety, tolerability and effect on immune activation.
Brouillette, MJ; Chomont, N; Costiniuk, CT; Cox, J; Jenabian, MA; Klein, MB; Lebouché, B; Mandarino, E; Margolese, S; Routy, JP; Saneei, Z; Singer, J; Szabo, J, 2019
)
0.51
" Side effects occurred, but severe adverse effects were mentioned in single cases only."( How effective and safe is medical cannabis as a treatment of mental disorders? A systematic review.
Friemel, CM; Hasan, A; Hoch, E; Niemann, D; Pogarell, O; Preuss, UW; Schneider, M; von Keller, R, 2019
)
0.51
" In this review, we summarize the major findings of several recent large-scale studies using this product with a focus on its adverse effects."( Epidiolex as adjunct therapy for treatment of refractory epilepsy: a comprehensive review with a focus on adverse effects.
Pack, A; Sekar, K, 2019
)
0.51
" CBD was well tolerated, and there were no serious adverse events reported during the trial."( A Phase 1, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment.
Crockett, J; Morrison, G; Taylor, L; Tayo, B, 2019
)
0.51
" Adverse events (AEs) were monitored and summarized for the safety analysis set (SAS) through 144 weeks."( Long-term safety and efficacy of cannabidiol in children and adults with treatment resistant Lennox-Gastaut syndrome or Dravet syndrome: Expanded access program results.
Bebin, EM; Checketts, D; Chez, M; Flamini, R; Laux, LC; Marsh, ED; Miller, I; Nichol, K; Park, Y; Segal, E; Seltzer, L; Szaflarski, JP; Thiele, EA; Weinstock, A, 2019
)
0.51
" Preclinical and clinical studies also report adverse effects (AEs) and toxicity following CBD intake."( Cannabidiol Adverse Effects and Toxicity.
Busardò, FP; Carlier, J; Huestis, MA; Pacifici, R; Pichini, S; Solimini, R, 2019
)
0.51
" Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks."( Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study
Andersen, TE; Bachmann, AG; Bojesen, AB; Christiansen, AA; Ellingsen, T; Hauge, EM; Hendricks, O; Horsted, TI; Krogh, NS; Loft, AG; Lund Hetland, M; Petersen, KH; Primdahl, J; Roessler, KK; Østergaard, M, 2019
)
0.51
"The majority of treatment-emergent AEs (reported by 85% of participants) were mild in severity (70%), and no serious adverse events were reported."( A phase 1/2, open-label assessment of the safety, tolerability, and efficacy of transdermal cannabidiol (ZYN002) for the treatment of pediatric fragile X syndrome.
Bonn-Miller, MO; Cohen, J; Du, W; Heussler, H; O'Neill, C; Sebree, T; Silove, N; Tich, N, 2019
)
0.51
" Safety assessments monitored vital signs, adverse effects, physical and neurological exams, and laboratory tests."( The safety, tolerability, and effectiveness of PTL-101, an oral cannabidiol formulation, in pediatric intractable epilepsy: A phase II, open-label, single-center study.
Chernuha, V; Deutsch, L; Fattal-Valevski, A; Hausman Kedem, M; Heffetz, D; Kramer, U; Mitelpunkt, A; Orbach, R; Sacks, H; Zilbershot Fink, E, 2019
)
0.51
" Most commonly reported treatment-related adverse effects were sleep disturbance/insomnia, (4 (25."( The safety, tolerability, and effectiveness of PTL-101, an oral cannabidiol formulation, in pediatric intractable epilepsy: A phase II, open-label, single-center study.
Chernuha, V; Deutsch, L; Fattal-Valevski, A; Hausman Kedem, M; Heffetz, D; Kramer, U; Mitelpunkt, A; Orbach, R; Sacks, H; Zilbershot Fink, E, 2019
)
0.51
"PTL-101 was safe and tolerable for use and demonstrated a potent seizure-reducing effect among pediatric patients with TRE."( The safety, tolerability, and effectiveness of PTL-101, an oral cannabidiol formulation, in pediatric intractable epilepsy: A phase II, open-label, single-center study.
Chernuha, V; Deutsch, L; Fattal-Valevski, A; Hausman Kedem, M; Heffetz, D; Kramer, U; Mitelpunkt, A; Orbach, R; Sacks, H; Zilbershot Fink, E, 2019
)
0.51
"This paper aimed to systematically examine the efficacy and adverse event (AE) profile of cannabidiol and medicinal cannabis by analyzing qualitative and meta-analytic data."( Efficacy and adverse event profile of cannabidiol and medicinal cannabis for treatment-resistant epilepsy: Systematic review and meta-analysis.
Almeida, KJ; Bor-Seng-Shu, E; da Silva Lopes, L; de Carvalho Reis, R; de Melo Mendes, CM, 2020
)
0.56
" However severe life-threatening reactions can also occur, and are often related to the non-controlled toxic combination with other antiseizure drugs that are widely used in this type of patients like sodium valproate or clobazam."( Adverse effects of cannabinoids.
Anciones, C; Gil-Nagel, A, 2020
)
0.56
" Main outcomes included ≥ 50% reduction in baseline convulsive seizure frequency and the incidence of treatment withdrawal and adverse events (AEs)."( Adjunctive Cannabidiol in Patients with Dravet Syndrome: A Systematic Review and Meta-Analysis of Efficacy and Safety.
Brigo, F; Del Giovane, C; Lattanzi, S; Silvestrini, M; Striano, P; Trinka, E; Zaccara, G, 2020
)
0.56
" We conducted the first systematic review and meta-analysis of the adverse effects of CBD across all medical indications."( Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials.
Chesney, E; Englund, A; Freeman, TP; Green, A; McGuire, P; Oliver, D; Sovi, S; Wilson, J, 2020
)
0.56
"Recent trials using cannabidiol (CBD) have shown that most acute and prolonged adverse effects of CBD are mild to moderate, with rare serious adverse effects (SAEs)."( Serious adverse effects of cannabidiol (CBD): a review of randomized controlled trials.
Crippa, JAS; Dos Santos, RG; Guimarães, FS; Hallak, JEC; Rocha, JM; Rossi, GN; Zuardi, AW, 2020
)
0.56
" Adverse events were predominantly mild or moderate in severity; however, three cases of hallucinations were reported."( Efficacy and safety of nabiximols cannabinoid medicine for paediatric spasticity in cerebral palsy or traumatic brain injury: a randomized controlled trial.
Checketts, D; Fairhurst, C; Kumar, R; Tayo, B; Turner, S, 2020
)
0.56
"Nabiximols was generally well tolerated; however, neuropsychiatric adverse events were observed."( Efficacy and safety of nabiximols cannabinoid medicine for paediatric spasticity in cerebral palsy or traumatic brain injury: a randomized controlled trial.
Checketts, D; Fairhurst, C; Kumar, R; Tayo, B; Turner, S, 2020
)
0.56
" Data relating to adverse events, vital signs, clinical laboratory assessments, 12-lead ECGs, physical examinations and concomitant medications were collected to assess safety and tolerability."( A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers.
Butler, J; Cox, S; Francis, B; Lilley, B; Mcintosh, M; Nguyen, TH; Ong, K; Perkins, D, 2020
)
0.56
" The most frequently reported treatment emergent adverse events (TEAEs) were headache (17%) and diarrhoea (8%)."( A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers.
Butler, J; Cox, S; Francis, B; Lilley, B; Mcintosh, M; Nguyen, TH; Ong, K; Perkins, D, 2020
)
0.56
" In addition, a number of studies suggest that, at least at high doses, there may be serious adverse effects or drug interactions associated with CBD."( Cannabidiol (CBD) in Dietary Supplements: Perspectives on Science, Safety, and Potential Regulatory Approaches.
ElSohly, MA; Gurley, BJ; Khan, I; Kingston, R; Koturbash, I; Walker, LA; Yates, CR, 2020
)
0.56
" The primary objective is to assess the effect of escalating doses of a 1:1 THC/CBD cannabinoid preparation against placebo on change in total symptom score, with secondary objectives including establishing a patient-determined effective dose, the change in total physical and emotional sores, global impression of change, anxiety and depression, opioid use, quality of life and adverse effects."( Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (
Gogna, G; Good, P; Greer, R; Hardy, J; Haywood, A; Martin, J; Yates, P, 2020
)
0.56
"The extract was generally well tolerated by participants when administered in either wafer or oil form, with some adverse events, including mild or moderate somnolence, sedation and altered mood."( A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.
Hosseini, A; Lickliter, JD; McLachlan, AJ, 2021
)
0.62
" The occurrence of adverse events (AEs) was also recorded."( Long-term efficacy and safety of cannabidiol (CBD) in children with treatment-resistant epilepsy: Results from a state-based expanded access program.
Diamond, MP; Flamini, JR; Linder, DF; Long, SA; Moretz, K; Park, YD; Pope, J, 2020
)
0.56
" Three serious adverse events (SAE) were reported but were not associated with the treatment."( Safety and efficacy of low-dose medical cannabis oils in multiple sclerosis.
Ab, O; Bs, R; F, S; Hb, S; K, L; Ps, S; R, T; S, G, 2021
)
0.62
"Treatment with medical cannabis oils was safe and well tolerated, and resulted in a reduction in pain intensity, spasticity and sleep disturbances in MS patients."( Safety and efficacy of low-dose medical cannabis oils in multiple sclerosis.
Ab, O; Bs, R; F, S; Hb, S; K, L; Ps, S; R, T; S, G, 2021
)
0.62
" Adverse Events were reported at/between study visits as required, and participants also completed Adverse Events Profile (AEP) which generates a numerical representation of AEs."( Long-term safety and efficacy of highly purified cannabidiol for treatment refractory epilepsy.
Ampah, SB; Cutter, GR; Gaston, TE; Grayson, LP; Hernando, K; Martina Bebin, E; Szaflarski, JP, 2021
)
0.62
" The most commonly reported adverse events in the study period were diarrhea, sedation, and decreased appetite."( Long-term safety and efficacy of highly purified cannabidiol for treatment refractory epilepsy.
Ampah, SB; Cutter, GR; Gaston, TE; Grayson, LP; Hernando, K; Martina Bebin, E; Szaflarski, JP, 2021
)
0.62
" In addition, CBD was generally well tolerated with minority of participants experiencing adverse events resulting in stopping CBD."( Long-term safety and efficacy of highly purified cannabidiol for treatment refractory epilepsy.
Ampah, SB; Cutter, GR; Gaston, TE; Grayson, LP; Hernando, K; Martina Bebin, E; Szaflarski, JP, 2021
)
0.62
" Treatment-emergent adverse events (TEAEs); plasma and urine concentrations of THC, CBD and metabolites; and self-reported subjective effects were collected."( Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.
Bonn-Miller, MO; Land, MH; MacNair, L; Mosesova, I; Peters, EN; Turcotte, C; Vandrey, R; Ware, MA, 2022
)
0.72
" Aligning with the known safety profile of nabiximols as demonstrated in randomized controlled trials, common adverse events reported consistently across studies conducted under clinical practice conditions were dizziness, fatigue and somnolence."( Safety and tolerability of nabiximols oromucosal spray: a review of real-world experience in observational studies, registries, and case reports.
Prieto González, JM; Vila Silván, C, 2021
)
0.62
" All observed adverse events (AEs) were mild, transient and resolved without medical intervention."( Safety and tolerability of escalating cannabinoid doses in healthy cats.
Eglit, GM; Kulpa, JE; Paulionis, LJ; Vaughn, DM, 2021
)
0.62
" All treatment-emergent adverse events (TEAEs) (65/65) were of mild-to-moderate severity; none was serious."( Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Red Softgels in Healthy Participants.
Bonn-Miller, MO; Land, MH; MacNair, L; Mosesova, I; Peters, EN; Turcotte, C; Vandrey, R; Ware, MA, 2022
)
0.72
" Adverse events were mild in severity."( Randomized, placebo-controlled, 28-day safety and pharmacokinetics evaluation of repeated oral cannabidiol administration in healthy dogs.
Kulpa, JE; Paulionis, LJ; Vaughn, DM, 2021
)
0.62
" Oral CBD was safe and well tolerated, producing small decreases in blood pressure (P < ."( A placebo-controlled investigation of the analgesic effects, abuse liability, safety and tolerability of a range of oral cannabidiol doses in healthy humans.
Arout, CA; Bedi, G; Cooper, ZD; Haney, M; Herrmann, ES, 2022
)
0.72
" Risk of adverse events, serious adverse events and withdrawals was computed as the incidence rate (IR)."( Safety and Tolerability of Natural and Synthetic Cannabinoids in Older Adults: A Systematic Review and Meta-Analysis of Open-Label Trials and Observational Studies.
Bhattacharyya, S; McGoohan, K; Pisani, S; Velayudhan, L, 2021
)
0.62
" THC had a very low incidence of all-cause and treatment-related adverse events (IR: 122."( Safety and Tolerability of Natural and Synthetic Cannabinoids in Older Adults: A Systematic Review and Meta-Analysis of Open-Label Trials and Observational Studies.
Bhattacharyya, S; McGoohan, K; Pisani, S; Velayudhan, L, 2021
)
0.62
"Although cannabinoid-based medications were generally safe and acceptable to adults aged over 50 years, these estimates are limited by the lack of a control condition and considerable heterogeneity."( Safety and Tolerability of Natural and Synthetic Cannabinoids in Older Adults: A Systematic Review and Meta-Analysis of Open-Label Trials and Observational Studies.
Bhattacharyya, S; McGoohan, K; Pisani, S; Velayudhan, L, 2021
)
0.62
"To describe the adverse events (AEs) of recreational cannabis use in France between 2012 and 2017."( Adverse events of recreational cannabis use reported to the French addictovigilance network (2012-2017).
Bouquet, E; Eiden, C; Fauconneau, B; Jouanjus, E; Pain, S; Pérault-Pochat, MC; Richard, N, 2021
)
0.62
" Adverse events (AEs) occurred in 96% of patients, serious AEs in 42%, and AE-related discontinuations in 12%."( Long-term safety and efficacy of add-on cannabidiol in patients with Lennox-Gastaut syndrome: Results of a long-term open-label extension trial.
Checketts, D; Chin, RF; Devinsky, O; Dunayevich, E; Gil-Nagel, A; Gunning, B; Halford, JJ; Mazurkiewicz-Bełdzińska, M; Mitchell, W; Patel, AD; Scott Perry, M; Thiele, EA; Weinstock, A, 2021
)
0.62
" Moreover, there were no reports of adverse effects associated with unfavorable inflammatory sequalae."( A pilot safety, tolerability and pharmacokinetic study of an oro-buccal administered cannabidiol-dominant anti-inflammatory formulation in healthy individuals: a randomized placebo-controlled single-blinded study.
Butcher, B; Hall, S; Henson, JD; Rutolo, D; Vitetta, L, 2021
)
0.62
" However, 5 participants, all of whom were in the treatment group, experienced serious adverse events: 4 cases of elevated liver enzymes (1 critical and 3 mild, with the mild elevations reported at the final 28-day assessment) and 1 case of severe pharmacodermia."( Efficacy and Safety of Cannabidiol Plus Standard Care vs Standard Care Alone for the Treatment of Emotional Exhaustion and Burnout Among Frontline Health Care Workers During the COVID-19 Pandemic: A Randomized Clinical Trial.
Andraus, MH; Campos, AC; Crippa, JAS; de Lima Osório, F; Dos Santos, RG; Esposito, DLA; Ferreira, RR; Fonseca, BAL; Guimarães, FS; Hallak, JEC; Kapczinski, F; Loureiro, SR; Mancini Costa, KC; Mechoulam, R; Pacheco, JC; Pereira-Lima, K; Pires-Dos-Santos, I; Scarante, FF; Scomparin, DS; Sen, S; Souza, JDS; Ushirohira, JM; Zuardi, AW, 2021
)
0.62
" However, it is necessary to balance the benefits of CBD therapy with potential undesired or adverse effects."( Efficacy and Safety of Cannabidiol Plus Standard Care vs Standard Care Alone for the Treatment of Emotional Exhaustion and Burnout Among Frontline Health Care Workers During the COVID-19 Pandemic: A Randomized Clinical Trial.
Andraus, MH; Campos, AC; Crippa, JAS; de Lima Osório, F; Dos Santos, RG; Esposito, DLA; Ferreira, RR; Fonseca, BAL; Guimarães, FS; Hallak, JEC; Kapczinski, F; Loureiro, SR; Mancini Costa, KC; Mechoulam, R; Pacheco, JC; Pereira-Lima, K; Pires-Dos-Santos, I; Scarante, FF; Scomparin, DS; Sen, S; Souza, JDS; Ushirohira, JM; Zuardi, AW, 2021
)
0.62
"Safety and tolerability assessments included adverse events (AEs) and examination of skin."( Safety and Tolerability of Transdermal Cannabidiol Gel in Children With Developmental and Epileptic Encephalopathies: A Nonrandomized Controlled Trial.
Ali, S; Griesser, J; Gutterman, DL; Hulihan, J; Keenan, N; Messenheimer, J; Sadleir, LG; Scheffer, IE; Sebree, T, 2021
)
0.62
" Fewer patients treated with NBX than LAO experienced treatment-related adverse events (25."( Effectiveness, Safety, and Tolerability of Nabiximols Oromucosal Spray vs Typical Oral Long-Acting Opioid Analgesics in Patients with Severe Neuropathic Back Pain: Analysis of 6-Month Real-World Data from the German Pain e-Registry.
Essner, U; Mueller-Schwefe, GHH; Ueberall, MA; Vila Silván, C, 2022
)
0.72
" The efficacy and safety were reported in terms of an at least 50% monthly seizure frequency reduction in drop seizures, dropout, and serious adverse events."( Efficacy and safety of antiseizure medication for Lennox-Gastaut syndrome: a systematic review and network meta-analysis.
Wang, C; Wang, J; Zhang, L, 2022
)
0.72
" Yet some key data gaps concerning the safe use of CBD still remain."( The current understanding of the benefits, safety, and regulation of cannabidiol in consumer products.
Bruner, L; Carvajal, R; Kaminski, NE; Li, J, 2021
)
0.62
"To estimate the timing of cannabidiol (CBD) treatment effect (seizure reduction and adverse events [AEs]) onset, we conducted a post hoc analysis of GWPCARE6 (NCT02544763), a randomized, placebo-controlled, phase 3 trial in patients with drug-resistant epilepsy associated with tuberous sclerosis complex (TSC)."( Time to onset of cannabidiol treatment effect and resolution of adverse events in tuberous sclerosis complex: Post hoc analysis of randomized controlled phase 3 trial GWPCARE6.
Checketts, D; Cock, HR; Devinsky, O; Joshi, C; Miller, I; Roberts, CM; Sahebkar, F; Sanchez-Carpintero, R; Wu, JY, 2022
)
0.72
"This review underlines that acute pancreatitis is a potential adverse effect of cannabinoid use."( Cannabinoid-Related Acute Pancreatitis: An Update from International Literature and Individual Case Safety Reports.
Azam, C; Buscail, L; Culetto, A; Lapeyre-Mestre, M, 2022
)
0.72
" ≥50% reduction in drop seizure frequency from baseline and occurrence of treatment-emergent adverse events (TEAEs) were the primary efficacy and safety outcomes."( Short-term and long-term efficacy and safety of antiseizure medications in Lennox Gastaut syndrome: A network meta-analysis.
Ameen, R; Bansal, D; Devi, N; Madaan, P; Sahu, JK, 2022
)
0.72
" A search of scientific literature was conducted to evaluate what is known about safe dose in food applications and determine what information is still needed to inform a standard or regulated limit."( Regulating for Safety: Cannabidiol Dose in Food: A Review.
Moyer, DC; Nyland, CR, 2022
)
0.72
" A search of scientific literature was conducted to evaluate what is known about safe dose in food applications and determine what information is still needed to inform a standard or regulated limit."( Regulating for Safety: Cannabidiol Dose in Food: A Review.
Moyer, DC; Nyland, CR, 2022
)
0.72
"Artisanal cannabidiol-enriched cannabis may be an effective and safe long-term treatment for refractory epilepsy."( The Long-Term Effectiveness and Safety of Cannabidiol-Enriched Oil in Children With Drug-Resistant Epilepsy.
Ben Zeev, B; Hamed, N; Heimer, G; Rabinowicz, S; Tzadok, M; Zohar-Dayan, E, 2022
)
0.72
" The aim of the present national survey was to describe adverse events (AEs) of recreational cannabis use during pregnancy reported to the French Addictovigilance Network (FAN)."( Adverse events of recreational cannabis use during pregnancy reported to the French Addictovigilance Network between 2011 and 2020.
Bouquet, E; Eiden, C; Fauconneau, B; Pain, S; Pérault-Pochat, MC; Pion, C, 2022
)
0.72
" The mainstay of treatment is with multiple anti-seizure medications (ASMs); however, the ASMs themselves can be associated with psychobehavioural adverse events, and effects (negative or positive) on cognition and sleep."( Psychobehavioural and Cognitive Adverse Events of Anti-Seizure Medications for the Treatment of Developmental and Epileptic Encephalopathies.
Schubert-Bast, S; Strzelczyk, A, 2022
)
0.72
" The key outcomes were reduction in seizure frequency, differences in 50% responder rates, adverse events, and interactions with clobazam as co-therapy."( Clinical efficacy and safety of cannabidiol for pediatric refractory epilepsy indications: A systematic review and meta-analysis.
Aparasu, R; Estes, E; Reddy, DS; Talwar, A, 2023
)
0.91
" Isolated cannabinoids illustrated different toxic effects on the viability of cells derived from colorectal polyps."( The Cytotoxic Effect of Isolated Cannabinoid Extracts on Polypoid Colorectal Tissue.
Ben-Ami Shor, D; Gluck, N; Hochman, I; Scapa, E; Shibolet, O, 2022
)
0.72
"Robust assessment of potential adverse outcomes is needed to determine a safe cannabidiol (CBD) intake level for consumer use."( Cannabidiol Safety Data: A Systematic Mapping Study.
Franke, KS; Franzen, A; Henderson, RG; Payne, LE, 2023
)
0.91
" While cannabidiol was generally safe and well tolerated even in high doses among the included studies, clearer dosing guidelines and increased regulation of cannabidiol products are also needed."( The Effectiveness and Safety of Cannabidiol in Non-seizure-related Indications: A Systematic Review of Published Randomized Clinical Trials.
Rudisill, TM; Tang, Y; Tonkovich, KL, 2022
)
0.72
"3% experienced treatment related adverse events."( A large Australian longitudinal cohort registry demonstrates sustained safety and efficacy of oral medicinal cannabis for at least two years.
Ernenwein, T; Kennedy, J; Roth, S; Vickery, AW; Washer, P, 2022
)
0.72
"Oral MC was demonstrated to be safe and well-tolerated for a sustained period in a large complex cohort of cannabis-naïve, multimorbid patients with polypharmacy."( A large Australian longitudinal cohort registry demonstrates sustained safety and efficacy of oral medicinal cannabis for at least two years.
Ernenwein, T; Kennedy, J; Roth, S; Vickery, AW; Washer, P, 2022
)
0.72
"This study aimed to explore the incidence of adverse events (AEs) reported by patients when initiating medicinal cannabis treatment for chronic pain, and the association of cannabis constituents, dose and concomitant medicines with AE incidence."( Medicinal cannabis for patients with chronic non-cancer pain: analysis of safety and concomitant medications.
Alffenaar, JC; Barlow, JW; Johnstone, MT; Schubert, EA; Wheate, NJ, 2023
)
0.91
" Adverse events (AEs) were documented at each visit."( Long-term efficacy and safety of cannabidiol in patients with treatment-resistant epilepsies: Four-year results from the expanded access program.
Checketts, D; Devinsky, O; Lopez, M; Park, YD; Patel, AD; Sahebkar, F; Szaflarski, JP; Thiele, EA; Wechsler, RT; Zentil, PP, 2023
)
0.91
" THC use appears to be associated with a higher proportion of serious adverse effects, including neuropsychological and cardiovascular effects."( Place of therapeutic cannabis in France and safety data: A literature review.
Bacle, A; Corso, B; Demay, E; Gicquel, T; Le Daré, B; Mercerolle, M; Pelletier, R, 2023
)
0.91
"The literature reports several frequent but rarely serious adverse effects of CBD during chronic use as well as a significant risk of drug interactions."( Place of therapeutic cannabis in France and safety data: A literature review.
Bacle, A; Corso, B; Demay, E; Gicquel, T; Le Daré, B; Mercerolle, M; Pelletier, R, 2023
)
0.91
"Cannabidiol-associated liver enzyme elevations and DILI meet the criteria of common adverse drug events."( Cannabidiol-associated hepatotoxicity: A systematic review and meta-analysis.
Barr, AM; Boivin, M; Christiansen, A; Eadie, L; Kim, DD; Lo, LA; MacCallum, CA; Strickland, JC, 2023
)
0.91
" We reviewed the scientific evidence on CBD-related toxicity and adverse events (AEs) in 2019, at the beginning of the spike in clinical studies involving CBD."( Update on Cannabidiol Clinical Toxicity and Adverse Effects: A Systematic Review.
Busardò, FP; Carlier, J; Giorgetti, R; Kapoor, A; Madeo, G, 2023
)
0.91
" Thus, the exact same dose and preparation of cannabis may be beneficial for some but toxic to others."( An Individuality of Response to Cannabinoids: Challenges in Safety and Efficacy of Cannabis Products.
Kitdumrongthum, S; Trachootham, D, 2023
)
0.91
" Cannabidiol (CBD) has been approved for the treatment of epilepsy, but its use has been associated with several different adverse events (AEs)."( Adverse Events of Cannabidiol Use in Patients With Epilepsy: A Systematic Review and Meta-analysis.
Fazlollahi, A; Gharagozli, K; Golabi, B; Kolahi, AA; Nejadghaderi, SA; Safiri, S; Sullman, MJM; Zahmatyar, M; ZareDini, M, 2023
)
0.91
" Additional studies are needed to determine the safe and effective CBD dosage for treating epilepsy."( Adverse Events of Cannabidiol Use in Patients With Epilepsy: A Systematic Review and Meta-analysis.
Fazlollahi, A; Gharagozli, K; Golabi, B; Kolahi, AA; Nejadghaderi, SA; Safiri, S; Sullman, MJM; Zahmatyar, M; ZareDini, M, 2023
)
0.91
" While currently available studies suggest that CBD is relatively safe for human consumption, data from publicly available studies on CBD conducted according to modern testing guidelines are lacking."( Oral toxicity evaluation of cannabidiol.
Bonn-Miller, MO; Borghoff, SJ; Heintz, MM; Henderson, RG; Lefever, TW; Trexler, KR, 2023
)
0.91
" Concomitant CBD use was recorded, and treatment-emergent adverse events (TEAEs) were collected."( Concomitant cannabidiol does not impact safety and effectiveness of diazepam nasal spray for seizure clusters: Post hoc analysis of a phase 3 safety study.
Carrazana, E; Misra, SN; Peters, JM; Puri, V; Rabinowicz, AL; Segal, E, 2023
)
0.91
" Cognitive adverse events were collected."( Cognitive Safety Data from a Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9-Tetrahydrocannabinol Drug on Parkinson's Disease-Related Motor Symptoms.
Adkins, M; Bainbridge, J; Domen, CH; Klawitter, J; Leehey, MA; Liu, Y; Rajkovic, S; Sempio, C; Sillau, S, 2023
)
0.91
" Adverse cognitive events were reported at least twice as often by the CBD/THC than the placebo group."( Cognitive Safety Data from a Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9-Tetrahydrocannabinol Drug on Parkinson's Disease-Related Motor Symptoms.
Adkins, M; Bainbridge, J; Domen, CH; Klawitter, J; Leehey, MA; Liu, Y; Rajkovic, S; Sempio, C; Sillau, S, 2023
)
0.91
" The most common adverse events reported were diarrhea (14 patients), fatigue (8 patients), headache (8 patients), and nausea (7 patients)."( A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis.
BouSaba, J; Burton, D; Busciglio, I; Camilleri, M; Carlson, P; Dilmaghani, S; Harmsen, WS; Ryks, M; Taylor, A; Torres, M; Zheng, T, 2023
)
0.91
"To evaluate the addition of CBD to antiseizure drugs (ASDs) on seizure frequency and to report adverse events in dogs with drug-resistant IE."( The efficacy and safety of cannabidiol as adjunct treatment for drug-resistant idiopathic epilepsy in 51 dogs: A double-blinded crossover study.
Bartner, LR; Corsato Alvarenga, I; Gustafson, DL; Kusick, BR; McGrath, S; Rao, S; Rozental, AJ; Weisbeck, BG,
)
0.13
"There was one adverse event (AE) in the active group (diarrhea) and two AEs in placebo (dry mouth; eye rash/swollen eye)."( A randomized, double-blind, placebo-controlled, repeated-dose pilot study of the safety, tolerability, and preliminary effects of a cannabidiol (CBD)- and cannabigerol (CBG)-based beverage powder to support recovery from delayed onset muscle soreness (DOM
Antonio, J; Bonn-Miller, MO; Eglit, GML; Harrison, A; Peters, EN; Turcotte, C; Yardley, H, 2023
)
0.91
" Using data from the FAERS database between 2018 and 2023, this study analyzed 13,275 Epidiolex-related adverse events."( Adverse events of epidiolex: A real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database.
Du, Z; Jiang, Y; Qu, K; Shen, Y; Zhang, X; Zhou, Q; Zhu, H, 2023
)
0.91

Pharmacokinetics

Cannabidiol (CBD) products are widely marketed to horse owners, trainers, and veterinarians. There is evidence of a pharmacokinetic (PK) interaction, leading to increased everolimus systemic exposure.

ExcerptReferenceRelevance
" The apparent terminal half-life of CBD calculated from the slope of the sigma minus plot was significantly shorter (2 h) than the half-life of CBD calculated from plasma data (8 h), and the apparent terminal half-life of the metabolites was similar to that of the CBD calculated from plasma data, indicating that the elimination of these metabolites was formation rate limited."( Pharmacokinetics of urinary metabolites of cannabidiol in the dog.
Bialer, M; Harvey, DJ; Samara, E, 1990
)
0.28
" It has a terminal half-life of 9 hr."( Pharmacokinetics of cannabidiol in dogs.
Bialer, M; Mechoulam, R; Samara, E,
)
0.13
" As a reason, pharmacodynamic as well as pharmacokinetic mechanisms were suggested."( Randomized, double-blind, placebo-controlled study about the effects of cannabidiol (CBD) on the pharmacokinetics of Delta9-tetrahydrocannabinol (THC) after oral application of THC verses standardized cannabis extract.
Fronk, EM; Nadulski, T; Pragst, F; Roser, P; Schnelle, M; Stadelmann, AM; Weinberg, G, 2005
)
0.33
" A drug's pharmacokinetics determines the onset, magnitude, and duration of its pharmacodynamic effects."( Pharmacokinetics and metabolism of the plant cannabinoids, delta9-tetrahydrocannabinol, cannabidiol and cannabinol.
Huestis, MA, 2005
)
0.33
" There are indications that CBD modulates THC's effects, but it is unclear if this is due to a pharmacokinetic and/or pharmacodynamic interaction."( Plasma cannabinoid pharmacokinetics following controlled oral delta9-tetrahydrocannabinol and oromucosal cannabis extract administration.
Darwin, WD; Goodwin, RS; Huestis, MA; Karschner, EL; Wright, S, 2011
)
0.37
"These data suggest that CBD modulation of THC's effects is not due to a pharmacokinetic interaction at these therapeutic doses."( Plasma cannabinoid pharmacokinetics following controlled oral delta9-tetrahydrocannabinol and oromucosal cannabis extract administration.
Darwin, WD; Goodwin, RS; Huestis, MA; Karschner, EL; Wright, S, 2011
)
0.37
"We here determined pharmacokinetic profiles of the above phytocannabinoids after acute single-dose intraperitoneal and oral administration in mice and rats."( Plasma and brain pharmacokinetic profile of cannabidiol (CBD), cannabidivarine (CBDV), Δ⁹-tetrahydrocannabivarin (THCV) and cannabigerol (CBG) in rats and mice following oral and intraperitoneal administration and CBD action on obsessive-compulsive behavi
Amada, N; Arthur, M; Close, S; Deiana, S; Dorward, P; Fleming, S; Pigliacampo, B; Platt, B; Riedel, G; Watanabe, A; Woodcock, H; Yamasaki, Y, 2012
)
0.38
" CBD inhibited obsessive-compulsive behaviour in a time-dependent manner matching its pharmacokinetic profile."( Plasma and brain pharmacokinetic profile of cannabidiol (CBD), cannabidivarine (CBDV), Δ⁹-tetrahydrocannabivarin (THCV) and cannabigerol (CBG) in rats and mice following oral and intraperitoneal administration and CBD action on obsessive-compulsive behavi
Amada, N; Arthur, M; Close, S; Deiana, S; Dorward, P; Fleming, S; Pigliacampo, B; Platt, B; Riedel, G; Watanabe, A; Woodcock, H; Yamasaki, Y, 2012
)
0.38
"The mean Cmax values (<12 ng/mL) recorded in this study were well below those reported in patients who smoked/inhaled cannabis, which is reassuring since elevated Cmax values are linked to significant psychoactivity."( A phase I study to assess the single and multiple dose pharmacokinetics of THC/CBD oromucosal spray.
Guy, GW; Stott, CG; White, L; Wilbraham, D; Wright, S, 2013
)
0.39
"This review examines the characteristics of nabiximols, its pharmacokinetic properties and data on efficacy and tolerability in MS-related neuropathic pain."( Pharmacokinetic evaluation of nabiximols for the treatment of multiple sclerosis pain.
Constantinescu, CS; Tanasescu, R, 2013
)
0.39
" Therefore, it is important that research into therapies is undertaken, particularly focusing on an understanding of the pharmacokinetic properties of compounds in this cachexic population."( Pharmacokinetics of Cannabis in Cancer Cachexia-Anorexia Syndrome.
Martin, JH; Reuter, SE, 2016
)
0.43
" Study objectives were to evaluate the safety and tolerability of PTL101 containing 10 and 100 mg CBD, following single administrations to healthy volunteers and to compare the pharmacokinetic profiles and relative bioavailability of CBD with Sativex oromucosal spray (the reference product) in a randomized, crossover study design."( Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology.
Atsmon, J; Deutsch, F; Deutsch, L; Heffetz, D; Sacks, H, 2018
)
0.48
"Model-based prediction on clinical doses for cannabinoids therapy is beneficial in the clinical setting, especially for seriously ill patients with both altered pharmacokinetics and pharmacodynamic responses."( Gaps in predicting clinical doses for cannabinoids therapy: Overview of issues for pharmacokinetics and pharmacodynamics modelling.
Liu, Z; Martin, JH, 2018
)
0.48
" As both THC and CBD are hepatically metabolized, the potential exists for pharmacokinetic drug interactions via inhibition or induction of enzymes or transporters."( The pharmacokinetics and the pharmacodynamics of cannabinoids.
Galettis, P; Lucas, CJ; Schneider, J, 2018
)
0.48
" Higher systemic exposures were observed with the oral CBD-infused oil formulation and the half-life after a 75-mg and 150-mg dose was 199."( Pharmacokinetics of cannabidiol administered by 3 delivery methods at 2 different dosages to healthy dogs.
Bartner, LR; Hyatt, LK; McGrath, S; Rao, S; Wittenburg, LA, 2018
)
0.48
" Pharmacokinetic parameters (primarily maximum measured plasma concentration, area under the plasma concentration-time curve from time zero to time t, area under the concentration-time curve from time zero to infinity, time to maximum plasma concentration, and terminal half-life) of CBD and its major metabolites were derived using non-compartmental analysis."( A Phase 1, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment.
Crockett, J; Morrison, G; Taylor, L; Tayo, B, 2019
)
0.51
" Serum and brain levels of antiepileptic drugs and cannabidiol were determined by using HPLC in order to ascertain any pharmacokinetic contribution to the observed behavioral effects."( Acute effect of cannabidiol on the activity of various novel antiepileptic drugs in the maximal electroshock- and 6 Hz-induced seizures in mice: Pharmacodynamic and pharmacokinetic studies.
Nieoczym, D; Socała, K; Szafarz, M; Wlaź, P; Wyska, E, 2019
)
0.51
" However, the intrinsic anticonvulsant activity of CBD has been questioned due to a pharmacokinetic interaction between CBD and a first-line medication, clobazam."( Coadministered cannabidiol and clobazam: Preclinical evidence for both pharmacodynamic and pharmacokinetic interactions.
Abelev, SV; Absalom, NL; Anderson, LL; Arnold, JC; Chebib, M; Doohan, PT; Low, IK; Martin, LJ; McGregor, IS, 2019
)
0.51
"Our study highlights the involvement of both pharmacodynamic and pharmacokinetic interactions between CBD and clobazam that may contribute to its efficacy in Dravet syndrome."( Coadministered cannabidiol and clobazam: Preclinical evidence for both pharmacodynamic and pharmacokinetic interactions.
Abelev, SV; Absalom, NL; Anderson, LL; Arnold, JC; Chebib, M; Doohan, PT; Low, IK; Martin, LJ; McGregor, IS, 2019
)
0.51
" However, few controlled clinical laboratory studies have evaluated the pharmacodynamic effects of oral or vaporized CBD or CBD-dominant cannabis."( Pharmacodynamic effects of vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis in infrequent cannabis users.
Bigelow, GE; Cone, EJ; Flegel, RR; Goffi, E; Mitchell, JM; Spindle, TR; Vandrey, R; Weerts, EM; Winecker, RE, 2020
)
0.56
" Both the safety and the pharmacokinetic populations of the stiripentol arm comprised 14 patients (2 placebo; 12 cannabidiol)."( A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy.
Arenas Cabrera, CM; Ben-Menachem, E; Critchley, D; Crockett, J; Gunning, B; Morrison, G; Tayo, B; Toledo, M; VanLandingham, K; Wray, L, 2020
)
0.56
" Plasma samples had been collected and analyzed for CBZ and CBZE, then their noncompartmental pharmacokinetic parameters before and after CBD administration were determined."( The effect of cannabidiol on the pharmacokinetics of carbamazepine in rats.
Darweesh, RS; El-Elimat, T; Khamis, TN, 2020
)
0.56
" The plasma half-life of THC is 1 to 3 days in occasional users and 5 to 13 days in chronic users."( Mechanisms of Action and Pharmacokinetics of Cannabis.
Chayasirisobhon, S, 2020
)
0.56
"Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, decision-making surrounding appropriate dosing of cannabis used for medical purposes is limited."( Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.
Bonn-Miller, MO; Land, MH; MacNair, L; Mosesova, I; Peters, EN; Turcotte, C; Vandrey, R; Ware, MA, 2022
)
0.72
" The terminal half-life for CBD was 10."( Pharmacokinetics and effects on arachidonic acid metabolism of low doses of cannabidiol following oral administration to horses.
Kass, PH; Knych, HK; McKemie, DS; Puschner, B; Ryan, D, 2021
)
0.62
"Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, informed physician and patient decision-making surrounding appropriate dosing of cannabis for medical purposes is limited."( Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Red Softgels in Healthy Participants.
Bonn-Miller, MO; Land, MH; MacNair, L; Mosesova, I; Peters, EN; Turcotte, C; Vandrey, R; Ware, MA, 2022
)
0.72
" Blood samples were collected at various time points to estimate 24-hour pharmacokinetic profiles of CBD and selected metabolites (7-carboxy-CBD and 7-hydroxy-CBD)."( Randomized, placebo-controlled, 28-day safety and pharmacokinetics evaluation of repeated oral cannabidiol administration in healthy dogs.
Kulpa, JE; Paulionis, LJ; Vaughn, DM, 2021
)
0.62
"This pharmacokinetic (PK) drug-interaction trial investigated the effects of repeated dosing of a plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex in the United States and Epidyolex in Europe; 100 mg/mL oral solution) on caffeine clearance via modulation of cytochrome P450 (CYP) 1A2 activity in healthy adults."( A Phase 1 Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects.
Critchley, D; Tayo, B; Thai, C, 2021
)
0.62
"3 h, n = 18), and oral dose formulation significantly impacted mean Cmax (Epidiolex = 1,274 ng/mL, capsule = 776 ng/mL, syrup = 151 ng/mL, n = 6/group) with little difference in Tmax."( Urinary Pharmacokinetic Profile of Cannabidiol (CBD), Δ9-Tetrahydrocannabinol (THC) and Their Metabolites following Oral and Vaporized CBD and Vaporized CBD-Dominant Cannabis Administration.
Bigelow, GE; Cone, EJ; Flegel, RR; Goffi, E; Kuntz, D; Mitchell, JM; Sholler, DJ; Spindle, TR; Vandrey, R; Winecker, RE, 2022
)
0.72
"Further pharmacokinetic examination of the interaction between CBD and citalopram/escitalopram is clearly warranted, and clinicians should be vigilant around the possibility of treatment-emergent adverse effects when CBD is introduced to patients taking these antidepressants."( Citalopram and Cannabidiol: In Vitro and In Vivo Evidence of Pharmacokinetic Interactions Relevant to the Treatment of Anxiety Disorders in Young People.
Amminger, GP; Anderson, LL; Arnold, JC; Berger, M; Doohan, PT; Kevin, RC; McGregor, IS; Oldfield, L,
)
0.13
" The most important pharmacokinetic parameters of the chosen 29 AEDs, mechanism of action and clinical application, as well as their biotransformation, are presented."( Pharmacokinetic Drug-Drug Interactions among Antiepileptic Drugs, Including CBD, Drugs Used to Treat COVID-19 and Nutrients.
Główka, AK; Główka, FK; Karaźniewicz-Łada, M; Mikulska, AA, 2021
)
0.62
" CBD concentrations were determined using a validated liquid chromatography-mass spectrometry method, and pharmacokinetic parameters were calculated using noncompartmental analysis."( Plasma and joint tissue pharmacokinetics of two doses of oral cannabidiol oil in guinea pigs (Cavia porcellus).
Gustafson, DL; Helbling, JE; McGrath, S; Sadar, MJ; Santangelo, KS; Spittler, AP, 2021
)
0.62
" Resulting pharmacokinetic parameters of CBD were compared to those obtained following administration of CBD in two oil-based formulations: a medium-chain triglyceride oil vehicle (MCT-CBD), and a sesame oil-based formulation similar in composition to an FDA-approved formulation of CBD, Epidiolex® (SO-CBD)."( Development and pharmacokinetic evaluation of a self-nanoemulsifying drug delivery system for the oral delivery of cannabidiol.
Ahmed, L; Allen, C; Bannigan, P; Dubins, D; Dunne, M; Evans, JC; Kok, LY; Regenold, M; Sanaee, F, 2022
)
0.72
" The aim of this study was to investigate similar dosing of CBG and CBGA from hemp plants that have been used for cannabidiol pharmacokinetic studies."( Single dose and chronic oral administration of cannabigerol and cannabigerolic acid-rich hemp extract in fed and fasted dogs: Physiological effect and pharmacokinetic evaluation.
Amstutz, K; Ellis, K; Gomez, B; Lyubimov, A; Schwark, WS; Venator, KP; Wakshlag, JJ; Zakharov, A, 2022
)
0.72
"Cannabidiol (CBD) products are widely marketed to horse owners, trainers, and veterinarians and are readily available to the consumer despite minimal pharmacokinetic or safety data being available."( Pharmacokinetics, Safety, and Synovial Fluid Concentrations of Single- and Multiple-Dose Oral Administration of 1 and 3 mg/kg Cannabidiol in Horses.
Contino, EK; Gustafson, DL; O'Fallon, ES; Yocom, AF, 2022
)
0.72
" This within-subject, double-blind, double-dummy, placebo-controlled laboratory study analyzed the pharmacokinetic profile of CBD, ∆9-tetrahydrocannabinol (∆9-THC) and related metabolites in blood and oral fluid (OF) after participants (n = 18) administered 100 mg of CBD in each of the following formulations: (1) oral CBD, (2) vaporized CBD and (3) vaporized CBD-dominant cannabis containing 10."( Pharmacokinetic Profile of ∆9-Tetrahydrocannabinol, Cannabidiol and Metabolites in Blood following Vaporization and Oral Ingestion of Cannabidiol Products.
Bergeria, CL; Bigelow, GE; Cone, EJ; Flegel, R; Goffi, E; Mitchell, JM; Sholler, D; Spindle, TR; Vandrey, R; Winecker, RE, 2022
)
0.72
" The rise in tissue CBD was closely related to specific pharmacokinetic parameters, and adipose tissue levels were ~10 to ~100 fold greater than liver or muscle."( Cannabidiol (CBD) Dosing: Plasma Pharmacokinetics and Effects on Accumulation in Skeletal Muscle, Liver and Adipose Tissue.
Child, RB; Tallon, MJ, 2022
)
0.72
" Since pharmacokinetic profiles are important in understanding the pharmacological and toxicological effects at the target sites, physiologically based pharmacokinetic (PBPK) modeling was used to predict the plasma and tissue concentrations of 17 cannabinoids in humans."( Physiologically based pharmacokinetic modeling and simulation of cannabinoids in human plasma and tissues.
Liu, Y; Sprando, RL, 2023
)
0.91
" The Cmax and AUC increased in a dose-proportional fashion across all dosing groups."( Pharmacokinetics of escalating single-dose administration of cannabidiol to cats.
Bartner, LR; Castro, SC; Gustafson, DL; Kusick, BR; McGrath, S; Rozental, AJ, 2023
)
0.91
" To consider an adult physiologically-based pharmacokinetic (PBPK) model for pediatric scaling, we assessed in vitro-derived cytochrome P450 (CYP) and uridine 5'-diphospho-glucuronosyltransferase (UGT) enzyme contributions to CBD clearance in human."( Verifying in vitro-determined enzyme contributions to cannabidiol clearance for exposure predictions in human through physiologically-based pharmacokinetic modeling.
Beers, JL; Edginton, AN; Jackson, KD; Yeung, CHT, 2023
)
0.91
" Relative to CYP cocktail + Δ9-THC, CYP cocktail + Δ9-THC + CBD produced a higher Cmax and area under the plasma concentration vs time curve for Δ9-THC, 11-OH-Δ9-THC, and Δ9-THC-COOH."( Assessment of Orally Administered Δ9-Tetrahydrocannabinol When Coadministered With Cannabidiol on Δ9-Tetrahydrocannabinol Pharmacokinetics and Pharmacodynamics in Healthy Adults: A Randomized Clinical Trial.
Bansal, S; Paine, MF; Spindle, TR; Surujunarain, R; Unadkat, JD; Vandrey, R; Weerts, EM; Zamarripa, CA, 2023
)
0.91
" Cannabidiol, Δ9-tetrahydrocannabinol, cannabinol, cannabichromene, cannabigerol, cannabidiolic acid, cannabigerolic acid, Δ9-tetrahydrocannabinolic acid, and 5 specific metabolites were measured by liquid chromatography-tandem/mass-spectrometry, and pharmacokinetic parameters were calculated."( Twice-daily oral administration of a cannabidiol and cannabidiolic acid-rich hemp extract was well tolerated in orange-winged Amazon parrots (Amazona amazonica) and has a favorable pharmacokinetic profile.
Beaufrère, H; Gomez, B; Guzman, DS; Knych, H; Lyubimov, A; Sosa-Higareda, M; Zakharov, A, 2023
)
0.91
" For the multiple-dose study, cannabidiol/cannabidiolic acid mean Cmax was 337."( Twice-daily oral administration of a cannabidiol and cannabidiolic acid-rich hemp extract was well tolerated in orange-winged Amazon parrots (Amazona amazonica) and has a favorable pharmacokinetic profile.
Beaufrère, H; Gomez, B; Guzman, DS; Knych, H; Lyubimov, A; Sosa-Higareda, M; Zakharov, A, 2023
)
0.91
"The goal of pharmacokinetic (PK) studies is to provide a basis for appropriate dosing regimens with novel therapeutic agents."( A One Health perspective on comparative cannabidiol and cannabidiolic acid pharmacokinetics and biotransformation in humans and domestic animals.
Schwark, WS; Wakshlag, JJ, 2023
)
0.91
" Such interactions can be predicted in healthy and hepatically-impaired (HI) adults and in children through physiologically based pharmacokinetic (PBPK) modeling and simulation."( A Physiologically-Based Pharmacokinetic Model for Cannabidiol in Healthy Adults, Hepatically-Impaired Adults, and Children.
Bansal, S; Ladumor, MK; Paine, MF; Unadkat, JD, 2023
)
0.91
"When highly purified cannabidiol (CBD; Epidiolex) and the mammalian target of rapamycin inhibitor everolimus are used concomitantly in the treatment of tuberous sclerosis complex, there is evidence of a pharmacokinetic (PK) interaction, leading to increased everolimus systemic exposure."( Pharmacokinetic Drug-Drug Interaction With Coadministration of Cannabidiol and Everolimus in a Phase 1 Healthy Volunteer Trial.
Berwaerts, J; Chen, C; Critchley, D; Hyland, K; Tayo, B; Thai, C; Wray, L, 2023
)
0.91
" A systematic pharmacokinetic study was performed to determine whether there are differences in the pharmacokinetic parameters and systemic exposure of CBD after oral dosing as an isolate, broad-spectrum, or full-spectrum product."( Comparative Pharmacokinetics of Commercially Available Cannabidiol Isolate, Broad-Spectrum, and Full-Spectrum Products.
Berthold, EC; Chiang, YH; Kamble, SH; Kanumuri, SRR; Kuntz, MA; McCurdy, CR; McMahon, LR; Senetra, AS; Sharma, A, 2023
)
0.91

Compound-Compound Interactions

The aim of this study was to assess potential drug-drug interactions between highly purified cannabidiol (CBD) and anti-seizure medications (ASMs)

ExcerptReferenceRelevance
" There was no demonstrable effect of CBD, either alone or in combination with ethanol."( The effect of cannabidiol, alone and in combination with ethanol, on human performance.
Belgrave, BE; Bird, KD; Chesher, GB; Jackson, DM; Lubbe, KE; Starmer, GA; Teo, RK, 1979
)
0.26
"A headspace solid-phase microextraction combined with GC-MS method was developed for the extraction and analysis of cannabinoids from Cannabis samples."( Extraction and analysis of different Cannabis samples by headspace solid-phase microextraction combined with gas chromatography-mass spectrometry.
Christen, P; Ilias, Y; Mathieu, P; Rudaz, S; Veuthey, JL, 2005
)
0.33
" Because CLB and CBD are both metabolized in the cytochrome P450 (CYP) pathway, we predicted a drug-drug interaction, which we evaluate in this article."( Drug-drug interaction between clobazam and cannabidiol in children with refractory epilepsy.
Bruno, PL; Geffrey, AL; Pollack, SF; Thiele, EA, 2015
)
0.42
"To determine, via narrative, non-systematic review of pre-clinical and clinical studies, whether the effect of cannabis on hepatic biotransformation pathways would be predicted to result in clinically significant drug-drug interactions (DDIs) with commonly prescribed psychotropic agents."( Drug-drug interactions as a result of co-administering Δ
Alageel, A; Almatham, F; Carmona, NE; Ho, RC; Lee, YL; Mansur, R; McIntyre, RS; Pan, Z; Ragguett, RM; Rong, C; Rosenblat, JD; Shekotikhina, M; Subramaniapillai, M, 2018
)
0.48
"Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use."( Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.
Barnes, AJ; Fischer, B; George, TP; Huestis, MA; Le Foll, B; Quilty, LC; Rehm, J; Selby, P; Soliman, A; Staios, G; Streiner, DL; Trigo, JM, 2018
)
0.48
"Following administration of a daily dosage of 10 mg delta-9-tetrahydrocannabinol combined with 20 mg cannabidiol (CBD), the patient showed a rapid and highly significant improvement in the Yale Global Tic Severity Scale."( Pure delta-9-tetrahydrocannabinol and its combination with cannabidiol in treatment-resistant Tourette syndrome: A case report.
Kawohl, W; Pichler, EM; Roser, P; Seifritz, E, 2019
)
0.51
" This open-label, fixed-sequence, drug-drug interaction, healthy volunteer trial investigated the impact of cannabidiol on steady-state pharmacokinetics of clobazam (and N-desmethylclobazam), stiripentol, and valproate; the reciprocal effect of clobazam, stiripentol, and valproate on cannabidiol and its major metabolites (7-hydroxy-cannabidiol [7-OH-CBD] and 7-carboxy-cannabidiol [7-COOH-CBD]); and cannabidiol safety and tolerability when coadministered with each antiepileptic drug."( A Phase 1, Open-Label, Pharmacokinetic Trial to Investigate Possible Drug-Drug Interactions Between Clobazam, Stiripentol, or Valproate and Cannabidiol in Healthy Subjects.
Blakey, G; Crockett, J; Morrison, G; Sommerville, K, 2019
)
0.51
" We report for the first time a significant drug-drug interaction between the purified CBD product and tacrolimus."( Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus.
Alloway, RR; Emoto, C; Fukuda, T; Leino, AD; Privitera, M; Vinks, AA, 2019
)
0.51
"Topoisomerase II (Topo2) inhibitors in combination with cisplatin represent a common treatment modality used for glioma patients."( Comparison of the effect of three different topoisomerase II inhibitors combined with cisplatin in human glioblastoma cells sensitized with double strand break repair inhibitors.
Galita, G; Kopa, P; Macieja, A; Majsterek, I; Pastwa, E; Poplawski, T, 2019
)
0.51
" In the secondary analyses, participants were divided into groups depending on whether they were taking at least 1/4 of the other AEDs shown to interact with CBD (iAED)."( Drug-drug interactions with cannabidiol (CBD) appear to have no effect on treatment response in an open-label Expanded Access Program.
Ampah, SB; Bebin, EM; Cutter, GR; Gaston, TE; Grayson, LP; Liu, Y; Szaflarski, JP, 2019
)
0.51
" This can be administered in combination with CBD, to prevent CRC secondary spread and enhance the synergistic efficacy of CRC treatment outcomes, with less side effects."( Possible Enhancement of Photodynamic Therapy (PDT) Colorectal Cancer Treatment when Combined with Cannabidiol.
Abrahamse, H; Kruger, CA; Nkune, NW, 2021
)
0.62
" This case report illustrates the potential for cannabidiol to interact with stable medication regimens."( Clinically Significant Drug-Drug Interaction Between Methadone and Cannabidiol.
Bruera, E; Madden, K; Tanco, K, 2020
)
0.56
"In this work, we evaluated, for the first time, the antitumor effect of cannabidiol (CBD) as monotherapy and in combination with conventional chemotherapeutics in ovarian cancer and developed PLGA-microparticles as CBD carriers to optimize its anticancer activity."( Enhancing ovarian cancer conventional chemotherapy through the combination with cannabidiol loaded microparticles.
Cohen, M; Delie, F; Fernández-Carballido, A; Figini, M; Fraguas-Sánchez, AI; Martin-Sabroso, C; Mezzanzanica, D; Satta, A; Torres-Suárez, AI, 2020
)
0.56
" It is important to consider the possibility of drug-drug interactions (DDIs)."( Clinical implications of trials investigating drug-drug interactions between cannabidiol and enzyme inducers or inhibitors or common antiseizure drugs.
Critchley, D; Gidal, B; Morrison, G; Patsalos, PN; Szaflarski, JP; VanLandingham, K, 2020
)
0.56
" In this study, widely employed inflammatory and noninflammatory animal pain models, such as the hot plate test, visceral pain model (writhing test), and carrageenan-induced rat paw edema model, were utilized to evaluate the antinociceptive and anti-inflammatory activity of CBD alone and in combination with standardized bioflavonoid compositions."( Antinociceptive and Anti-Inflammatory Properties of Cannabidiol Alone and in Combination with Standardized Bioflavonoid Composition.
Brownell, L; Hong, M; Horm, T; Jia, Q; Jiao, P; O'Neal, A; Rossiter, S; Yimam, M, 2021
)
0.62
"The microencapsulation method combined with a permeation enhancer, DCA increased the short-term bioavailability of CBD in plasma and brain."( Sodium alginate microencapsulation improves the short-term oral bioavailability of cannabidiol when administered with deoxycholic acid.
Al-Salami, H; Al-Sallami, H; Brook, E; Eden, E; Galettis, P; Lam, V; Majimbi, M; Mamo, JCL; Mooranian, A; Takechi, R, 2021
)
0.62
"The legalization of cannabis in many parts of the United States and other countries has led to a need for a more comprehensive understanding of cannabis constituents and their potential for drug-drug interactions."( Cannabinoid Metabolites as Inhibitors of Major Hepatic CYP450 Enzymes, with Implications for Cannabis-Drug Interactions.
Lazarus, P; Nasrin, S; Perez-Paramo, YX; Watson, CJW, 2021
)
0.62
" The purpose of this review is to present data from the last few years on drug-drug interactions among of AEDs, as well as AEDs with other drugs, nutrients and food."( Pharmacokinetic Drug-Drug Interactions among Antiepileptic Drugs, Including CBD, Drugs Used to Treat COVID-19 and Nutrients.
Główka, AK; Główka, FK; Karaźniewicz-Łada, M; Mikulska, AA, 2021
)
0.62
"To assess drug-drug interactions between cannabidiol (CBD) and phenobarbital (PB) when simultaneously administered to healthy dogs."( Drug-drug interaction between cannabidiol and phenobarbital in healthy dogs.
Bartner, LR; Cribb, AE; Doran, CE; Gustafson, DL; McGrath, S; Thomas, B, 2021
)
0.62
"This is a patient case exploring the importance of evaluating herbal and dietary supplements and how they may impact drug-drug and drug-gene implications based on pharmacogenomics test results."( Implications of Cannabidiol in Pharmacogenomic-Based Drug Interactions with CYP2C19 Substrates.
Crosby, S; Engeleit, A; Schuh, MJ, 2021
)
0.62
"To describe the presence, type, and management of drug-drug interactions (DDIs) at prescription cannabidiol (CBD) therapy initiation."( Prescription cannabidiol for seizure disorder management: Initial drug-drug interaction management by specialty pharmacists.
Choi, L; DeClercq, J; Dial, H; Johnson, K; Owens, W; Shah, NB; Zuckerman, AD, 2022
)
0.72
" In light of the increasing appearance of phytocannabinoids in beauty products without rigorous research on their rejuvenation efficacy, we decided to investigate the potential role of phytocannabinoids in combination with nutrient signaling regulators in skin rejuvenation."( The Effects of Nutrient Signaling Regulators in Combination with Phytocannabinoids on the Senescence-Associated Phenotype in Human Dermal Fibroblasts.
Gerasymchuk, M; Kovalchuk, I; Kovalchuk, O; Robinson, GI, 2022
)
0.72
" A single dose of everolimus 5 mg was well tolerated when administered with multiple doses of CBD."( Pharmacokinetic Drug-Drug Interaction With Coadministration of Cannabidiol and Everolimus in a Phase 1 Healthy Volunteer Trial.
Berwaerts, J; Chen, C; Critchley, D; Hyland, K; Tayo, B; Thai, C; Wray, L, 2023
)
0.91
"The aim of this study was to assess potential drug-drug interactions between highly purified cannabidiol (CBD) and anti-seizure medications (ASMs)."( Final analysis of potential drug-drug interactions between highly purified cannabidiol and anti-seizure medications in an open-label expanded access program.
Bebin, EM; Cutter, GR; Gaston, TE; Grayson, L; Szaflarski, JP, 2023
)
0.91

Bioavailability

Cannabidiol (CBD) is a prescribed drug for epilepsy but has low oral bioavailability and gastric instability. It is suggested that the inhibition of hepatic metabolism determined an increased bioavailability of cannabidio resulting in a greater effect.

ExcerptReferenceRelevance
" In the other three, the oral bioavailability ranged from 13 to 19%."( Pharmacokinetics of cannabidiol in dogs.
Bialer, M; Mechoulam, R; Samara, E,
)
0.13
" In the other four, the oral bioavailability was 3, 21, 39, and 43%, respectively."( Pharmacokinetics of the dimethylheptyl homolog of cannabidiol in dogs.
Bialer, M; Samara, E,
)
0.13
" In four subjects who received intravenous and oral hexobarbital, systemic clearance was 36% lower while bioavailability was 10% greater during CBD."( Metabolic and psychophysiologic studies of cannabidiol-hexobarbital interaction.
Bachman, J; Benowitz, NL; Herning, RI; Jones, RT; Nguyen, TL, 1980
)
0.26
" The absolute bioavailability (F) of THC decreased in the following order: sublingual THC/RM-beta-CD solution (F = 12."( Effects of RM-beta-CD on sublingual bioavailability of Delta9-tetrahydrocannabinol in rabbits.
Jarho, P; Järvinen, K; Järvinen, T; Mannila, J; Tarvainen, M, 2005
)
0.33
" It is suggested that the inhibition of hepatic metabolism determined an increased bioavailability of cannabidiol resulting in a greater effect."( Antihyperalgesic effect of a Cannabis sativa extract in a rat model of neuropathic pain: mechanisms involved.
Bettoni, I; Colleoni, M; Comelli, F; Costa, B; Giagnoni, G, 2008
)
0.35
"CBD was absorbed intranasally within 10 minutes with a bioavailability of 34-46%, except with 100% polyethylene glycol formulation in rats."( Cannabidiol bioavailability after nasal and transdermal application: effect of permeation enhancers.
Agu, RU; Hammell, DC; Paudel, KS; Stinchcomb, AL; Valiveti, S, 2010
)
0.36
" Relative bioavailability was calculated to determine the relative rate and extent of THC absorption; 5 and 15 mg oral THC bioavailability was 92."( Plasma cannabinoid pharmacokinetics following controlled oral delta9-tetrahydrocannabinol and oromucosal cannabis extract administration.
Darwin, WD; Goodwin, RS; Huestis, MA; Karschner, EL; Wright, S, 2011
)
0.37
"To assess the effect of food on the single-dose bioavailability of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) spray, an endocannabinoid system modulator, when administered to healthy male subjects."( A phase I study to assess the effect of food on the single dose bioavailability of the THC/CBD oromucosal spray.
Guy, GW; Stott, CG; White, L; Wilbraham, D; Wright, S, 2013
)
0.39
" The bioavailability of THC was greater than CBD at single and multiple doses, and there was no evidence of accumulation for any analyte with multiple dosing."( A phase I study to assess the single and multiple dose pharmacokinetics of THC/CBD oromucosal spray.
Guy, GW; Stott, CG; White, L; Wilbraham, D; Wright, S, 2013
)
0.39
" A high-quality, rigorous, phase I/II study to elicit pharmacokinetic dose-concentration and concentration-response data, with a clinically acceptable mode of delivery to reduce intrapatient variability and enable more consistent bioavailability is needed in this population."( Pharmacokinetics of Cannabis in Cancer Cachexia-Anorexia Syndrome.
Martin, JH; Reuter, SE, 2016
)
0.43
"" Lack of standardization, bioavailability issues, and ultimately prohibition were all factors in cannabis-based medicines failing to maintain mainstream usage in seizure treatment, but investigation was resumed in the 1970s with interesting signals noted in both laboratory and clinical settings."( Cannabis and epilepsy: An ancient treatment returns to the fore.
Russo, EB, 2017
)
0.46
" Study objectives were to evaluate the safety and tolerability of PTL101 containing 10 and 100 mg CBD, following single administrations to healthy volunteers and to compare the pharmacokinetic profiles and relative bioavailability of CBD with Sativex oromucosal spray (the reference product) in a randomized, crossover study design."( Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology.
Atsmon, J; Deutsch, F; Deutsch, L; Heffetz, D; Sacks, H, 2018
)
0.48
" Their pharmacokinetics are complex, and bioavailability is variable, resulting in difficulty in developing a suitable formulation for oral delivery."( Cannabinoids for epilepsy: What do we know and where do we go?
Ben-Menachem, E; Brodie, MJ, 2018
)
0.48
" The oral bioavailability of THC and CBD is very low due to extensive "first-pass" metabolism."( PTL401, a New Formulation Based on Pro-Nano Dispersion Technology, Improves Oral Cannabinoids Bioavailability in Healthy Volunteers.
Atsmon, J; Cherniakov, I; Deutsch, F; Deutsch, L; Domb, AJ; Heffetz, D; Hoffman, A; Izgelov, D; Sacks, H, 2018
)
0.48
" A larger AUC was found in the fasted group; the relative oral bioavailability in fed animals was 48."( Pharmacokinetics of Bedrocan®, a cannabis oil extract, in fasting and fed dogs: An explorative study.
Chericoni, S; Giorgi, M; Lisowski, A; Owen, H; Poapolathep, A; Stefanelli, F; Łebkowska-Wieruszewska, B, 2019
)
0.51
" CBD has complex and variable pharmacokinetics, with a prominent first-pass effect and a low oral bioavailability that increases fourfold when CBD is taken with a high-fat/high-calorie meal."( Pharmacological and Therapeutic Properties of Cannabidiol for Epilepsy.
Franco, V; Perucca, E, 2019
)
0.51
" However, current formulations suffer from low bioavailability and side effects."( The safety, tolerability, and effectiveness of PTL-101, an oral cannabidiol formulation, in pediatric intractable epilepsy: A phase II, open-label, single-center study.
Chernuha, V; Deutsch, L; Fattal-Valevski, A; Hausman Kedem, M; Heffetz, D; Kramer, U; Mitelpunkt, A; Orbach, R; Sacks, H; Zilbershot Fink, E, 2019
)
0.51
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" A dose-exposure proportionality assessment was performed, and a population-based meta-analysis of CBD pharmacokinetics and systemic bioavailability was conducted with a nonlinear mixed-effects modeling."( Model-Based Analysis of Cannabidiol Dose-Exposure Relationship and Bioavailability.
Lim, SY; Sharan, S; Woo, S, 2020
)
0.56
"Oral solution CBD exposures increased less than proportionally with doses of 750 mg or greater, and bioavailability (6."( Model-Based Analysis of Cannabidiol Dose-Exposure Relationship and Bioavailability.
Lim, SY; Sharan, S; Woo, S, 2020
)
0.56
"5-fold increase in oral bioavailability of CBD compared to control group without piperine."( The effect of piperine on oral absorption of cannabidiol following acute vs. chronic administration.
Domb, AJ; Hoffman, A; Izgelov, D, 2020
)
0.56
" Thus, a higher and less variable bioavailability can be obtained."( Prolonged oral transmucosal delivery of highly lipophilic drug cannabidiol.
Barasch, D; Domb, AJ; Hoffman, A; Itin, C, 2020
)
0.56
" Here, we evaluated CBD for its ability to modulate the production of proinflammatory cytokines in vitro and in murine models of induced inflammation and further validated the ability of a liposomal formulation to increase bioavailability in mice and in humans."( A randomized, double-blind, placebo-controlled study of daily cannabidiol for the treatment of canine osteoarthritis pain.
Blair, E; Decker, WK; Dunner, K; Halpert, MM; Hofferek, CJ; Konduri, V; Salimpour, P; Vazquez-Perez, J; Verrico, CD; Wesson, S, 2020
)
0.56
" However, these vehicles not only affect drug bioavailability but may also have an impact on gastric emptying, drug disposition, lymphatic absorption and be affected by lipid digestion mechanisms."( Using the Absorption Cocktail Approach to Assess Differential Absorption Kinetics of Cannabidiol Administered in Lipid-Based Vehicles in Rats.
Domb, AJ; Hoffman, A; Izgelov, D; Regev, A, 2020
)
0.56
" In-vivo investigation of CBD containing formulation in the freely moving rat model proved a prolonged absorption phase with a substantial increase in bioavailability compared to CBD solution."( Investigation of cannabidiol gastro retentive tablets based on regional absorption of cannabinoids in rats.
Freidman, M; Hoffman, A; Izgelov, D, 2020
)
0.56
" Although detailed studies have not been published, the available data suggest that the absolute bioavailability of CBD after oral dosing under fasting conditions is approximately 6%, and increases fourfold when the medication is co-administered with a high-fat meal."( Critical Aspects Affecting Cannabidiol Oral Bioavailability and Metabolic Elimination, and Related Clinical Implications.
Bialer, M; Perucca, E, 2020
)
0.56
" Increasing intestinal lymphatic transport provides an effective strategy to improve oral bioavailability when hepatic first-pass metabolism is a major rate-limiting step hampering access to the systemic circulation after oral dosing."( The Interplay Between Liver First-Pass Effect and Lymphatic Absorption of Cannabidiol and Its Implications for Cannabidiol Oral Formulations.
Bialer, M; Franco, V; Gershkovich, P; Perucca, E, 2020
)
0.56
" Cannabidiol is rapidly absorbed and its  bioavailability increases when administered with high fat meals."( Clinical pharmacology of cannabidiol in refractory epilepsy.
Cáceres-Guido, P; Maldonado, C; Riva, N; Schaiquevich, P; Vázquez, M, 2020
)
0.56
" The relative bioavailability of CBD after administration as a sublingual wafer was comparable with that of oil solution with 90% confidence interval of 83-131%."( A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.
Hosseini, A; Lickliter, JD; McLachlan, AJ, 2021
)
0.62
" However, the oral bioavailability of CBD is low owing to its high lipophilicity and extensive first-pass metabolism."( Mucoadhesive nanostructured lipid carriers as a cannabidiol nasal delivery system for the treatment of neuropathic pain.
Bonfílio, R; Carvalho, FC; Elisei, LMS; Galdino, G; Matarazzo, AP; Pereira, GR; Ruela, ALM, 2021
)
0.62
" The bioavailability and pharmacokinetics of CBD are not well understood, and proper dosing schemes have not been adequately developed for its clinical use."( Food effects on the formulation, dosing, and administration of cannabidiol (CBD) in humans: A systematic review of clinical studies.
Capparelli, EV; Rosania, GR; Silmore, LH; Willmer, AR, 2021
)
0.62
" The bioavailability of inhaled THC is 10% to 35%."( Mechanisms of Action and Pharmacokinetics of Cannabis.
Chayasirisobhon, S, 2020
)
0.56
" Previous studies have shown that natural sesame oil promotes the intestinal lymphatic transport and oral bioavailability of the highly lipophilic drug cannabidiol (CBD)."( Natural sesame oil is superior to pre-digested lipid formulations and purified triglycerides in promoting the intestinal lymphatic transport and systemic bioavailability of cannabidiol.
Barrett, DA; Berton, M; Bettonte, S; Chu, Y; Constantinescu, CS; Feng, W; Fischer, PM; Gershkovich, P; Lee, JB; Qin, C; Stocks, MJ; Zgair, A, 2021
)
0.62
" These include low oral bioavailability due to hepatic degradation, gastric instability, poor water solubility, and the side effects experienced upon the use of high doses of psychotropic cannabinoids associated with heightened plasma concentrations of the drug."( Delivering therapeutic cannabinoids via skin: Current state and future perspectives.
Chukwunyere, UI; Frempong, D; Mishra, D; Puri, A; Thakur, D; Tijani, AO, 2021
)
0.62
" However, the potential therapeutic use of cannabis and cannabinoids for the treatment of respiratory diseases has not been widely investigated, in part because of local irritation of airways by needing to smoke the cannabis, poor bioavailability when administered orally due to the lipophilic nature of cannabinoids, and the psychoactive effects of Δ9-Tetrahydrocannabinol (Δ9-THC) found in cannabis."( The anti-inflammatory effects of cannabidiol and cannabigerol alone, and in combination.
Clarkson, N; Horniman, N; Keir-Rudman, S; Page, C; Robaina Cabrera, CL, 2021
)
0.62
" However, CBD is lipophilic and highly photooxidative with low oral bioavailability in plasma and brain."( Sodium alginate microencapsulation improves the short-term oral bioavailability of cannabidiol when administered with deoxycholic acid.
Al-Salami, H; Al-Sallami, H; Brook, E; Eden, E; Galettis, P; Lam, V; Majimbi, M; Mamo, JCL; Mooranian, A; Takechi, R, 2021
)
0.62
"The microencapsulation method combined with a permeation enhancer, DCA increased the short-term bioavailability of CBD in plasma and brain."( Sodium alginate microencapsulation improves the short-term oral bioavailability of cannabidiol when administered with deoxycholic acid.
Al-Salami, H; Al-Sallami, H; Brook, E; Eden, E; Galettis, P; Lam, V; Majimbi, M; Mamo, JCL; Mooranian, A; Takechi, R, 2021
)
0.62
" Animal and human studies have shown its poor oral bioavailability in vivo, and the impact of consuming lipid-soluble CBD with and without food on gut bioaccessibility has not been explored."( The Effects of Food on Cannabidiol Bioaccessibility.
Guzman, I; Holguin, FO; Kovar, SE; Lucker, BF; Mozaffari, K; Willette, S, 2021
)
0.62
" These data indicate that DPI CBD provided more rapid onset and increased bioavailability than oral CBD and support further investigations on the use of DPI CBD for acute indications."( Improved Bioavailability with Dry Powder Cannabidiol Inhalation: A Phase 1 Clinical Study.
Devinsky, O; Fein, M; Kraft, K; Leone-Bay, A; Rusch, L, 2021
)
0.62
" These absorption obstacles are responsible for low and variable oral bioavailability of CBD."( Enhanced Intramuscular Bioavailability of Cannabidiol Using Nanocrystals: Formulation, In Vitro Appraisal, and Pharmacokinetics.
Chen, K; Fan, H; Fu, X; Kou, L; Li, Z; Wang, Y; Xie, Z; Xu, S; Zhang, S, 2022
)
0.72
" CBD had dose-dependent, but variable, oral bioavailability at 1 mg/kg and 3 mg/kg daily dosing and was consistently detectable at steady state in synovial fluid at the higher dose."( Pharmacokinetics, Safety, and Synovial Fluid Concentrations of Single- and Multiple-Dose Oral Administration of 1 and 3 mg/kg Cannabidiol in Horses.
Contino, EK; Gustafson, DL; O'Fallon, ES; Yocom, AF, 2022
)
0.72
" However, its low solubility and bioavailability impede its applications in functional foods."( Nutraceutical potential of industrial hemp (
Chen, B; Rao, J; Zheng, H, 2022
)
0.72
"Nanoparticle encapsulation is an attractive approach to improve the oral bioavailability of hydrophobic therapeutics."( Development of an
Caggiano, NJ; Priestley, RD; Prud'homme, RK; Wilson, BK, 2022
)
0.72
"Although natural sesame oil has been shown to facilitate the lymphatic delivery and oral bioavailability of the highly lipophilic drug cannabidiol (CBD), considerable variability remains an unresolved challenge."( Vegetable oils composition affects the intestinal lymphatic transport and systemic bioavailability of co-administered lipophilic drug cannabidiol.
Abdelrazig, S; Bai, Z; Barrett, DA; Chu, Y; Constantinescu, CS; Darwish, R; Feng, W; Fischer, PM; Gershkovich, P; Gray, DA; Ji, L; Qin, C; Raji, M; Stocks, MJ, 2022
)
0.72
"Pharmacokinetics and bioavailability of CBD in senior horses were determined, and there were no adverse effects of administering either the oral or IV dose of CBD evaluated."( Pharmacokinetics of cannabidiol in a randomized crossover trial in senior horses.
Adams, AA; Knych, HK; Turner, SE, 2022
)
0.72
"Cannabidiol (CBD) is a prescribed drug for epilepsy but has low oral bioavailability and gastric instability."( Development of cannabidiol nanoemulsion for direct nose to brain delivery: statistical optimization,
Ahmed, B; Akhtar, MS; Amin, S; Mir, SR; Rizwanullah, M, 2022
)
0.72
" Pharmacokinetic studies in dogs have demonstrated a low oral bioavailability of CBD and a high first-pass effect through the liver."( Cannabidiol in canine epilepsy.
Bhatti, SFM; McGrath, S; Potschka, H; Tipold, A, 2022
)
0.72
" The water-soluble cannabis-based medicine provided acceptable bioavailability for Δ9-THC/CBD, appeared safe and tolerable in advanced incurable cancers with uncontrolled pain with preliminary evidence of analgesic efficacy."( Pilot clinical and pharmacokinetic study of Δ9-Tetrahydrocannabinol (THC)/Cannabidiol (CBD) nanoparticle oro-buccal spray in patients with advanced cancer experiencing uncontrolled pain.
Butcher, BE; Clarke, S; Hall, S; Henson, JD; McLachlan, AJ; Rutolo, D; Vitetta, L, 2022
)
0.72
"Intravenous pharmacokinetics and oral bioavailability of cannabidiol (CBD) with different formulations have not been investigated in horses and may represent a starting point for clinical studies."( Pharmacokinetics and oral bioavailability of cannabidiol in horses after intravenous and oral administration with oil and micellar formulations.
Becero, M; Díez de Castro, E; Ferreiro-Vera, C; García-Valverde, MT; Muñoz, A; Saitua, A; Sánchez de Medina, A; Sánchez de Medina, V; Serrano-Rodríguez, JM, 2023
)
0.91
" Oral bioavailability was close to 14% for both oral administrations."( Pharmacokinetics and oral bioavailability of cannabidiol in horses after intravenous and oral administration with oil and micellar formulations.
Becero, M; Díez de Castro, E; Ferreiro-Vera, C; García-Valverde, MT; Muñoz, A; Saitua, A; Sánchez de Medina, A; Sánchez de Medina, V; Serrano-Rodríguez, JM, 2023
)
0.91
"Oral bioavailability was low at the doses studied but fell within the range described for horse and other species."( Pharmacokinetics and oral bioavailability of cannabidiol in horses after intravenous and oral administration with oil and micellar formulations.
Becero, M; Díez de Castro, E; Ferreiro-Vera, C; García-Valverde, MT; Muñoz, A; Saitua, A; Sánchez de Medina, A; Sánchez de Medina, V; Serrano-Rodríguez, JM, 2023
)
0.91
" Due to the slow absorption and low bioavailability with the current oral CBD therapy, more efficient routes of administration to bypass hepatic metabolism, particularly pulmonary delivery, should be considered."( Cannabidiol for the Treatment of Brain Disorders: Therapeutic Potential and Routes of Administration.
Arnold, JC; Chan, HK; Kwok, PCL; Tai, W; Yau, GTY, 2023
)
0.91
"An emulsion delivery system may be affected significantly by oil phase composition in terms of digestion behavior and bioavailability of the delivered substance."( Digestion behavior, in vitro and in vivo bioavailability of cannabidiol in emulsions stabilized by whey protein-maltodextrin conjugate: Impact of carrier oil.
Dong, C; Freeman, K; Guo, M; Lu, Y; Wang, C, 2023
)
0.91
" However, the poor solubility and low bioavailability limit its clinical application."( Cannabidiol-Loaded Poly Lactic-Co-Glycolic Acid Nanoparticles with Improved Bioavailability as a Potential for Osteoarthritis Therapeutic.
Jin, Z; Qin, Z; Wei, Q; Xu, S; Zhan, Y; Zheng, L, 2023
)
0.91
" Our previous studies proved the effectiveness of cannabidiol (CBD) against PTSD, but low water solubility, low brain targeting efficiency and poor bioavailability restricted its applications."( Cannabidiol-loaded biomimetic macrophage membrane vesicles against post-traumatic stress disorder assisted by ultrasound.
Dai, J; Du, L; Gao, P; Hu, J; Jiao, W; Jin, Y; Li, Q; Song, X; Tang, Z; Wang, C; Wu, Y, 2023
)
0.91
"There was an increase in the oral bioavailability of CBD (12% and 21% in male and female rats, respectively) when administered as a full-spectrum product compared with the isolate and broad-spectrum products."( Comparative Pharmacokinetics of Commercially Available Cannabidiol Isolate, Broad-Spectrum, and Full-Spectrum Products.
Berthold, EC; Chiang, YH; Kamble, SH; Kanumuri, SRR; Kuntz, MA; McCurdy, CR; McMahon, LR; Senetra, AS; Sharma, A, 2023
)
0.91
"2% THC increased the oral bioavailability of CBD in male and female rats, indicating that full-spectrum products may produce increased effectiveness of CBD due to a greater exposure available systemically."( Comparative Pharmacokinetics of Commercially Available Cannabidiol Isolate, Broad-Spectrum, and Full-Spectrum Products.
Berthold, EC; Chiang, YH; Kamble, SH; Kanumuri, SRR; Kuntz, MA; McCurdy, CR; McMahon, LR; Senetra, AS; Sharma, A, 2023
)
0.91
" However, its high lipophilicity, chemical instability, and extensive metabolism impair its bioavailability and clinical use."( Cannabidiol nanoemulsion for eye treatment - Anti-inflammatory, wound healing activity and its bioavailability using in vitro human corneal substitute.
Cejnar, P; Hynek, R; Kaštánek, P; Kronusová, O; Ruml, T; Šach, J; Strnad, O; Sukupová, A; Šuman, J; Tran, VN; Veverková, T; Viktorová, J, 2023
)
0.91
" Degradation in the gastrointestinal (GI) tract, first-pass metabolism, and low water solubility restrain bioavailability of CBD to only 6% in current oral administration."( Archaeosomes facilitate storage and oral delivery of cannabidiol.
Horn, C; Quehenberger, J; Sedlmayr, V; Spadiut, O; Wurm, DJ, 2023
)
0.91
" This limitation necessitates the exploration of various approaches to enhance the bioavailability of CBD, thus helping to maximize its therapeutic potential."( Current Challenges and Opportunities for Improved Cannabidiol Solubility.
Alghalayini, A; Hossain, KR; Valenzuela, SM, 2023
)
0.91
" However, due to their low water solubility and prominent first-pass metabolism, their oral bioavailability is moderate, which is unfavorable for medicinal use."( Mannich-type modifications of (-)-cannabidiol and (-)-cannabigerol leading to new, bioactive derivatives.
Ádám, D; Bácskay, I; Bereczki, I; Borbás, A; Herczeg, M; Herczegh, P; Hodek, J; Lőrincz, EB; Minorics, R; Nagy, L; Oláh, A; Ostorházi, E; Spolárics, J; Tóth, G; Weber, J; Zouboulis, CC; Zupkó, I, 2023
)
0.91

Dosage Studied

Study found that acute dosing of cannabidiol over 24 h can lower blood pressure and arterial stiffness in individuals with untreated hypertension.

ExcerptRelevanceReference
" Food and water consumption were dramatically reduced by each test drug at feeding periods immediately following and in some instances up to 4 days after dosing in all 3 groups."( Comparative effects of various naturally occurring cannabinoids on food, sucrose and water consumption by rats.
Knobloch, LC; Sofia, RD, 1976
)
0.26
"The acute dose-response effects of delta-9-tetrahydrocannabinol (THC), cannabinol (CBN) and cannabidiol (CBD) on gonadotropin and testosterone (T) secretion and on hypothalamic norepinephrine (NE) metabolism were tested in adult male rats."( Effects of psychoactive and nonpsychoactive cannabinoids on the hypothalamic-pituitary axis of the adult male rat.
Bartke, A; Murphy, LL; Smith, MS; Steger, RW, 1990
)
0.28
" Cannabinol (CBN) showed the same activity but required a dosage of approximately eight times that of THC to produce an equivalent effect."( The quasi-morphine withdrawal syndrome: effect of cannabinol, cannabidiol and tetrahydrocannabinol.
Chesher, GB; Jackson, DM, 1985
)
0.27
"A Langendorff perfused rat heart preparation was designed to process dose-response effects of cardioactive drugs on rate, coronary flow, and supraaortic differential pressure (delta P; an index of cardiac performance)."( Effects and interactions of natural cannabinoids on the isolated heart.
Nahas, G; Trouve, R, 1985
)
0.27
"5 days after dosing with THC."( Evidence that cannabidiol does not significantly alter the pharmacokinetics of tetrahydrocannabinol in man.
Bachman, J; Herning, RI; Hunt, CA; Jones, RT, 1981
)
0.26
" In contrast, cannabidiol, over a wide dosage range, caused only depression."( Excitatory and depressant effects of delta 9-tetrahydrocannabinol and cannabidiol on cortical evoked responses in the conscious rat.
Karler, R; Turkanis, SA, 1981
)
0.26
" In animals initially anesthetized with pentobarbital, delta-9-THC over a wide dosage range produced only an enhancement of the reflex, whereas in methohexital-treated animals only depression was elicited."( Influence of different barbiturate anesthetics on delta-9-tetrahydrocannabinol effects on spinal monosynaptic reflexes.
Karler, R; Turkanis, SA, 1983
)
0.27
"In audiogenic seizure (AGS) susceptible rats, the acute (intraperitoneal and intravenous) dose-response effects of (--)-cannabidiol (CBD) for preventing AGS and for causing rototod neurotoxicity (ROT) were determined."( Antiepileptic potential of cannabidiol analogs.
Consroe, P; Martin, A; Singh, V,
)
0.13
" Three patients had transient hypotension and intoxication with rapid initial dosing of THC-containing CME."( A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms.
Aram, J; House, H; Makela, P; Robson, P; Wade, DT, 2003
)
0.32
" Sativex is a sublingual spray on Cannabis extract basis, and is equipped with an electronic tool to facilitate accurate dosing and to prevent misuses."( [A novel analgesics made from Cannabis].
Szendrei, K, 2004
)
0.32
" Regimens for the use of the sublingual spray emerged and a wide range of dosing requirements was observed."( Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 'N of 1' studies.
Miller, R; Newport, S; Notcutt, W; Phillips, C; Price, M; Sansom, C; Simmons, S, 2004
)
0.32
" Patients self titrate their overall dose and pattern of dosing according to their response to and tolerance of the medicine."( Sativex: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain.
Barnes, MP, 2006
)
0.33
" No tolerance to the benefit of Sativex on pain or sleep, nor need for dosage increases have been noted in safety extension studies of up to four years, wherein 40-50% of subjects attained good or very good sleep quality, a key source of disability in chronic pain syndromes that may contribute to patients' quality of life."( Cannabis, pain, and sleep: lessons from therapeutic clinical trials of Sativex, a cannabis-based medicine.
Guy, GW; Robson, PJ; Russo, EB, 2007
)
0.34
"CBD injected into the dlPAG produced anxiolytic-like effects in the EPM with a bell-shaped dose-response curve."( Involvement of 5HT1A receptors in the anxiolytic-like effects of cannabidiol injected into the dorsolateral periaqueductal gray of rats.
Campos, AC; Guimarães, FS, 2008
)
0.35
"Sulphasalazine, THC and CBD proved beneficial in this model of colitis with the dose-response relationship for the phytocannabinoids showing a bell-shaped pattern on the majority of parameters (optimal THC and CBD dose, 10 mg."( The effects of Delta-tetrahydrocannabinol and cannabidiol alone and in combination on damage, inflammation and in vitro motility disturbances in rat colitis.
Jamontt, JM; Molleman, A; Parsons, ME; Pertwee, RG, 2010
)
0.36
"Nine cannabis smokers completed all 5 dosing sessions."( Plasma cannabinoid pharmacokinetics following controlled oral delta9-tetrahydrocannabinol and oromucosal cannabis extract administration.
Darwin, WD; Goodwin, RS; Huestis, MA; Karschner, EL; Wright, S, 2011
)
0.37
" In an experimental mouse model of MS-related spasticity, Sativex dose-dependently improved hind limb flexion/stiffness and a dosage of 10 mg/kg was shown to be as effective as the most widely established anti-spasticity treatment baclofen (5 mg/kg)."( Endocannabinoid pathways and their role in multiple sclerosis-related muscular dysfunction.
Di Marzo, V, 2011
)
0.37
" CBD also displayed significant potency (in a bell-shaped dose-response curve) at enhancing the ability of 8-OH-DPAT to stimulate [(35) S]GTPγS binding to rat brainstem membranes in vitro."( Cannabidiol, a non-psychotropic component of cannabis, attenuates vomiting and nausea-like behaviour via indirect agonism of 5-HT(1A) somatodendritic autoreceptors in the dorsal raphe nucleus.
Anavi-Goffer, S; Bolognini, D; Cascio, MG; Fletcher, PJ; Limebeer, CL; Mechoulam, R; Parker, LA; Pertwee, RG; Rock, EM, 2012
)
0.38
" The objective of the present work was to assess the feasibility of developing cannabinoid loaded poly-ε-caprolactone (PCL) microparticles prepared by the oil-in-water emulsion-solvent evaporation technique as a suitable dosage form for their administration."( Poly-ε-caprolactone microspheres as a drug delivery system for cannabinoid administration: development, characterization and in vitro evaluation of their antitumoral efficacy.
Aberturas, MR; Di Marzo, V; Gil-Alegre, ME; Hernán Pérez de la Ossa, D; Ligresti, A; Molpeceres, J; Torres Suárez, AI, 2012
)
0.38
" Secondary outcomes were to determine evidence of developing tolerance and to assess the long-term dosing profile of Sativex."( Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis.
Collin, C; Notcutt, W; Serpell, MG, 2013
)
0.39
" Finally, activation of TRPV1 channels may help us to explain the antipsychotic effect and the bell-shaped dose-response curves commonly observed with CBD."( Multiple mechanisms involved in the large-spectrum therapeutic potential of cannabidiol in psychiatric disorders.
Campos, AC; Del Bel, EA; Gomes, FV; Guimarães, FS; Moreira, FA, 2012
)
0.38
"5 h after dosing and analyzed for THC, CBD, cannabinol (CBN), and 11-nor-9-carboxy-THC (THCCOOH)."( Can oral fluid cannabinoid testing monitor medication compliance and/or cannabis smoking during oral THC and oromucosal Sativex administration?
Barnes, AJ; Goodwin, RS; Huestis, MA; Karschner, EL; Lee, D; Milman, G, 2013
)
0.39
" THCCOOH/THC ratios increased throughout each dosing session."( Can oral fluid cannabinoid testing monitor medication compliance and/or cannabis smoking during oral THC and oromucosal Sativex administration?
Barnes, AJ; Goodwin, RS; Huestis, MA; Karschner, EL; Lee, D; Milman, G, 2013
)
0.39
" There was evidence of dose-proportionality in the single but not the multiple dosing data sets."( A phase I study to assess the single and multiple dose pharmacokinetics of THC/CBD oromucosal spray.
Guy, GW; Stott, CG; White, L; Wilbraham, D; Wright, S, 2013
)
0.39
"Neuropathic pain caused by chemotherapy limits dosing and duration of potentially life-saving anti-cancer treatment and impairs quality of life."( A double-blind, placebo-controlled, crossover pilot trial with extension using an oral mucosal cannabinoid extract for treatment of chemotherapy-induced neuropathic pain.
Cesar-Rittenberg, P; Hohmann, AG; Lynch, ME, 2014
)
0.4
" The mean dosage was 4 sprays/day."( Clinical experience with THC:CBD oromucosal spray in patients with multiple sclerosis-related spasticity.
Feneberg, W; Koehler, J; Meier, M; Pöllmann, W, 2014
)
0.4
" Oral fluid was tested prior to and immediately after dosing with either Sativex(®) or placebo at intervals up to 2h after the dose."( The detection of THC, CBD and CBN in the oral fluid of Sativex® patients using two on-site screening tests and LC-MS/MS.
Allsop, DJ; Copeland, J; Fu, S; Lewis, J; Molnar, A, 2014
)
0.4
" A dose-response curve was performed to establish a sublethal dose of CBD with antioxidant activity (2."( Cannabidiol Exposure During Neuronal Differentiation Sensitizes Cells Against Redox-Active Neurotoxins.
Bristot, IJ; Castro, MA; Crippa, JA; De Bastiani, MA; de Medeiros, LM; Kapczinski, F; Klamt, F; Lopes, FM; Parsons, RB; Schönhofen, P, 2015
)
0.42
" CBD promoted an inverted U-shaped dose-response curve in the anxiety task; in the memory assessment, CBD in the dose of 5mg/Kg promoted the strongest effects without interfering with social and aggressive behavior."( Caffeine protects against memory loss induced by high and non-anxiolytic dose of cannabidiol in adult zebrafish (Danio rerio).
Antonioli, R; Bonan, CD; Capiotti, KM; Crippa, JA; da Silva, RS; Hallak, JE; Nazario, LR; Zuardi, AW, 2015
)
0.42
" Meaningful symptomatic improvement was achieved within the recommended dosage limit of ≤12 sprays per day."( Effect of Sativex on spasticity-associated symptoms in patients with multiple sclerosis.
Dechant, KL; Meuth, SG; Vila, C, 2015
)
0.42
" Open-label studies performed to date with a focus on effectiveness have indicated that about one-half to two-thirds of patients initiated on THC:CBD oromucosal spray continue to derive benefit after 3 months' treatment at a mean dosage of 5-7 sprays/day."( Advances in the management of MS symptoms: real-life evidence.
Trojano, M, 2015
)
0.42
" Stretch reflex responders were taking a significantly higher number of puffs, whereas no differences were found in the responders by the other scales, suggesting that a higher dosage would add benefit if tolerated."( The effect of cannabinoids on the stretch reflex in multiple sclerosis spasticity.
Abbruzzese, G; Bandini, F; Canneva, S; Capello, E; Colombano, F; Currà, A; Fattapposta, F; Marinelli, L; Mori, L; Trompetto, C, 2016
)
0.43
" No significant symptomatic effects were detected at the prescribed dosage and for a 12-week period."( A double-blind, randomized, cross-over, placebo-controlled, pilot trial with Sativex in Huntington's disease.
Alonso Arias, MA; Fernández Ruiz, J; Galve-Roperh, I; García Caldentey, J; García de Yébenes Prous, J; García de Yébenes, MJ; García Ribas, G; García-Bermejo, ML; Guzmán, M; López-Sendón Moreno, JL; Ortega-Gutierrez, S; Resel, E; Ruiz Romero, C; Sagredo, O; Tolón, RM; Trigo Cubillo, P; Valdeolivas, S, 2016
)
0.43
" Our results show that the cannabidiol (5μM) and moringin (5μM) combination outperformed the single constituents that, at this dosage had only a moderate efficacy on inflammatory (Tumor necrosis factor-α, Interleukin-10) and oxidative markers (inducible nitric oxide synthase, nuclear factor erythroid 2-related factor 2, nitrotyrosine)."( Anti-inflammatory and antioxidant effects of a combination of cannabidiol and moringin in LPS-stimulated macrophages.
Bramanti, P; De Nicola, GR; Giacoppo, S; Grassi, G; Iori, R; Mazzon, E; Pollastro, F; Rajan, TS, 2016
)
0.43
"Sativex was well-tolerated by all participants (average dosage 77."( Sativex Associated With Behavioral-Relapse Prevention Strategy as Treatment for Cannabis Dependence: A Case Series.
Barnes, AJ; Fischer, B; George, TP; Huestis, MA; Le Foll, B; Quilty, L; Rehm, J; Selby, P; Soliman, A; Staios, G; Trigo, JM,
)
0.13
" THC:CBD mean dosage was 6 sprays/day."( Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice.
Trojano, M; Vermersch, P, 2016
)
0.43
" We lack valid data on the safety, efficacy, and dosing of artisanal preparations available from dispensaries in the 25 states and District of Columbia with MMJ programs and online sources of CBD and other cannabinoids."( Cannabinoids in treatment-resistant epilepsy: A review.
Devinsky, O; Gloss, D; O'Connell, BK, 2017
)
0.46
", methods of administration (smoking, vaporisation, oral), and dosing recommendations."( Practical considerations in medical cannabis administration and dosing.
MacCallum, CA; Russo, EB, 2018
)
0.48
" The dosage of CBD was gradually increased to at least 8mg/kg/day."( Cannabidiol for treatment of refractory childhood epilepsies: Experience from a single tertiary epilepsy center in Slovenia.
Neubauer, D; Osredkar, D; Perković Benedik, M, 2018
)
0.48
" Mechanism-based PK and PD models are promising for improved predictive dosing performance for ill and comorbid patients."( Gaps in predicting clinical doses for cannabinoids therapy: Overview of issues for pharmacokinetics and pharmacodynamics modelling.
Liu, Z; Martin, JH, 2018
)
0.48
" This paper provides an overview of the available cannabinoid-based formulations, a summary of the highest quality evidence for the use of cannabinoids for treating spasticity and pain associated with multiple sclerosis (MS), and a discussion of possible dosing regimens based on information from these studies."( Cannabinoids for Treatment of MS Symptoms: State of the Evidence.
Cameron, M; Rice, J, 2018
)
0.48
" This study will provide the first high quality analysis of safety of CBD-enriched Cannabis herbal extract in pediatric patients in relation to dosage and pharmacokinetics of the active cannabinoids."( The protocol for the Cannabidiol in children with refractory epileptic encephalopathy (CARE-E) study: a phase 1 dosage escalation study.
Acton, B; Alcorn, J; Carmant, L; Corley, S; Huh, L; Huntsman, RJ; Leung, E; Lim, HJ; Lyon, AW; Mousseau, DD; Prosser-Loose, E; Reithmeier, D; Seifert, B; Tang-Wai, R; Tellez-Zenteno, J, 2018
)
0.48
"We aimed to assess the potential relationship between intrasubject 9-tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray plasma profiles and clinical effects elicited by subacute dosing in chronically treated patients with multiple sclerosis (MS)."( Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship.
Contin, M; Foschi, M; Lugaresi, A; Mancinelli, L; Mohamed, S; Perrone, A; Riva, R; Sabattini, L; Scandellari, C; Vacchiano, V,
)
0.13
" No significant effect of cannabinoids dosing could be appreciated according to posturographic and motor tests."( Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship.
Contin, M; Foschi, M; Lugaresi, A; Mancinelli, L; Mohamed, S; Perrone, A; Riva, R; Sabattini, L; Scandellari, C; Vacchiano, V,
)
0.13
" Although preliminary, they suggest that subacute dosing might elicit a subjective clinically significant effect on MS-related spasticity, paralleling cannabinoids measurable plasma concentrations."( Tetrahydrocannabinol/Cannabidiol Oromucosal Spray in Patients With Multiple Sclerosis: A Pilot Study on the Plasma Concentration-Effect Relationship.
Contin, M; Foschi, M; Lugaresi, A; Mancinelli, L; Mohamed, S; Perrone, A; Riva, R; Sabattini, L; Scandellari, C; Vacchiano, V,
)
0.13
"Following administration of a daily dosage of 10 mg delta-9-tetrahydrocannabinol combined with 20 mg cannabidiol (CBD), the patient showed a rapid and highly significant improvement in the Yale Global Tic Severity Scale."( Pure delta-9-tetrahydrocannabinol and its combination with cannabidiol in treatment-resistant Tourette syndrome: A case report.
Kawohl, W; Pichler, EM; Roser, P; Seifritz, E, 2019
)
0.51
" We initiated CBD in 72 children and 60 adults with treatment-resistant epilepsy (TRE) at 5 mg/kg/day and titrated it up to a maximum dosage of 50 mg/kg/day."( Cannabidiol improves frequency and severity of seizures and reduces adverse events in an open-label add-on prospective study.
Bebin, EM; Cutter, G; DeWolfe, J; Dure, LS; Gaston, TE; Kankirawatana, P; Liu, Y; Singh, R; Standaert, DG; Szaflarski, JP; Thomas, AE; Ver Hoef, LW, 2018
)
0.48
"Cannabidiol (CBD), one of the non-psychotomimetic compounds of Cannabis sativa, causes anxiolytic-like effects in animals, with typical bell-shaped dose-response curves."( Cannabidiol presents an inverted U-shaped dose-response curve in a simulated public speaking test.
Crippa, JA; Guimarães, FS; Linares, IM; Mechoulam, R; Pereira, LC; Queiroz, RH; Zuardi, AW,
)
0.13
"Our findings confirm the anxiolytic-like properties of CBD and are consonant with results of animal studies describing bell-shaped dose-response curves."( Cannabidiol presents an inverted U-shaped dose-response curve in a simulated public speaking test.
Crippa, JA; Guimarães, FS; Linares, IM; Mechoulam, R; Pereira, LC; Queiroz, RH; Zuardi, AW,
)
0.13
" Hence, the incorporation of CBD in lipid nanocapsules (LNCs) will contribute to overcome the dosing problems associated with cannabinoids."( Lipid nanocapsules decorated and loaded with cannabidiol as targeted prolonged release carriers for glioma therapy: In vitro screening of critical parameters.
Aparicio-Blanco, J; Benoit, JP; Sebastián, V; Torres-Suárez, AI, 2019
)
0.51
" CBD was given on an open-label, flexible dosing regimen to patients diagnosed with PTSD by a mental health professional."( Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series.
Elms, L; Hughes, S; Lewis, N; Shannon, S, 2019
)
0.51
" Without independent laboratory verification, it is impossible to know whether the labeled CBD dosage in non-FDA-approved CBD products is correct, that the delta-9-tetrahydrocannabinol content is <0."( A Review of Human Studies Assessing Cannabidiol's (CBD) Therapeutic Actions and Potential.
White, CM, 2019
)
0.51
" Blood samples were collected until 48 hours after dosing and evaluated by liquid chromatography and tandem mass spectrometry."( A Phase 1, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment.
Crockett, J; Morrison, G; Taylor, L; Tayo, B, 2019
)
0.51
" Highly purified grade CBD (Epidiolex®) dosing was weight-based and could be increased every 2 weeks by 5 mg/kg/day up to a maximum dosage of 50 mg/kg/day depending on tolerance and seizure control."( Higher cannabidiol plasma levels are associated with better seizure response following treatment with a pharmaceutical grade cannabidiol.
Ampah, SB; Bebin, EM; Gaston, TE; Grayson, LE; Hernando, K; Moreadith, R; Szaflarski, JP, 2019
)
0.51
"In this open-label study, we found evidence of a linear correlation between CBD dosage and plasma levels, and that higher dose/levels are associated with a higher response rate for seizure improvement."( Higher cannabidiol plasma levels are associated with better seizure response following treatment with a pharmaceutical grade cannabidiol.
Ampah, SB; Bebin, EM; Gaston, TE; Grayson, LE; Hernando, K; Moreadith, R; Szaflarski, JP, 2019
)
0.51
" Patients received a single dose (5, 10, or 20 mg/kg) on day 1 and twice-daily dosing on days 4 through 10 (10-mg/kg [cohort 1], 20-mg/kg [cohort 2], or 40-mg/kg [cohort 3] total daily dose)."( Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy.
Cilio, MR; Dlugos, D; Miller, I; Oh, DA; Parikh, N; Phillips, S; Renfroe, JB; Roberts, CM; Saeed, I; Sparagana, SP; Wheless, JW; Yu, J, 2019
)
0.51
" Approximately 2-6 days of twice-daily dosing provided steady-state concentrations of cannabidiol."( Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy.
Cilio, MR; Dlugos, D; Miller, I; Oh, DA; Parikh, N; Phillips, S; Renfroe, JB; Roberts, CM; Saeed, I; Sparagana, SP; Wheless, JW; Yu, J, 2019
)
0.51
" Given the correlation between plasma CBD concentration and seizure frequency, additional research is warranted to determine whether a higher dosage of CBD would be effective in reducing seizure activity by ≥ 50%."( Randomized blinded controlled clinical trial to assess the effect of oral cannabidiol administration in addition to conventional antiepileptic treatment on seizure frequency in dogs with intractable idiopathic epilepsy.
Bartner, LR; Gustafson, DL; McGrath, S; Packer, RA; Rao, S, 2019
)
0.51
" From this literature review, dosage for treatment and management is provided."( Medical Marijuana in the Pediatric Population With Epilepsy-What You Should Know.
Markle, M; Nativio, DG,
)
0.13
" Crystalline extract CBD powder (98-99% pure) in an oil artisanal formulation was added to the baseline AED regimen at a dosage of 2-5 mg/kg/day divided for twice-daily administration, then up-titrated until intolerance or a maximum dosage of 25 mg/kg/day was reached."( Purified Cannabidiol for Treatment of Refractory Epilepsies in Pediatric Patients with Developmental and Epileptic Encephalopathy.
Calabrese, C; Cappelletti, S; Carfì Pavia, G; de Palma, L; Ferretti, A; Pietrafusa, N; Specchio, N; Tondo, I; Trivisano, M; Vigevano, F, 2019
)
0.51
" Also, due to the complex pharmacology of cannabinoids, interindividual genetic differences in the metabolisation of ∆9-tetrahydrocannabinol (THC), the individual structure and function of the cannabinoid receptors, as well as differences in receptor density and distribution, the dosage and frequency of application must be individually determined."( [Cannabis for medical purposes and its prescription].
Bussick, D; Eckert-Lill, C; Hörnig, M; Kiefer, A; Reimann, H, 2019
)
0.51
" Only 2 of 39 participants were able to give an exact dosage used in milligrams."( Marijuana use among patients with epilepsy at a tertiary care center.
Ernst, L; Kellogg, M; Kerr, A; Walston, V; Wong, VSS, 2019
)
0.51
"The results observed in this study are useful for guiding future pharmacokinetic studies of medicinal cannabinoids, and for development of dosing guidelines for medical use of cannabis in the 'real-world' setting."( Model-based analysis on systemic availability of co-administered cannabinoids after controlled vaporised administration.
Broyd, SJ; de Krey, P; Galettis, P; Greenwood, LM; Liu, Z; Martin, JH; Schneider, J; Solowij, N; Steigler, A; van Hell, H; Zhu, X, 2020
)
0.56
" Despite supra-physiological dosing being shown to be tolerable in various pathologies, optimization of CBD absorption has obvious benefits for general health and recreational usage."( Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled Pharmacokinetics Study.
Ainslie, PN; Banic, I; Dujić, Ž; Marendic, M; Mijacika, T; Patrician, A; Sutlović, D; Versic-Bratincevic, M, 2019
)
0.51
" Further studies are needed to establish the mechanisms of action of this technology and to explore the therapeutic potential of acute and chronic dosing on more at-risk populations."( Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled Pharmacokinetics Study.
Ainslie, PN; Banic, I; Dujić, Ž; Marendic, M; Mijacika, T; Patrician, A; Sutlović, D; Versic-Bratincevic, M, 2019
)
0.51
" There was considerable heterogeneity in dose, route of administration and THC:CBD ratio across studies and no clear dose-response profile emerged."( How does cannabidiol (CBD) influence the acute effects of delta-9-tetrahydrocannabinol (THC) in humans? A systematic review.
Curran, HV; Freeman, AM; Freeman, TP; Hindocha, C; Lees, R; Mokrysz, C; Petrilli, K; Saunders, R, 2019
)
0.51
" These data indicate that acute dosing of pure CBD will not result in a positive urine drug test using current federal workplace drug testing guidelines (50-ng/mL IA cutoff with 15-ng/mL confirmatory cutoff)."( Urinary Pharmacokinetic Profile of Cannabinoids Following Administration of Vaporized and Oral Cannabidiol and Vaporized CBD-Dominant Cannabis.
Bigelow, GE; Cone, EJ; Flegel, R; Kuntz, D; Mitchell, JM; Spindle, TR; Vandrey, R, 2020
)
0.56
"Two reviewers independently extracted the following data from the articles: year of publication; study design; patient characteristics (sex; type of anxiety disorder; use of concomitant anxiolytic therapy); dosing strategy and route of CBD administration; and safety and efficacy outcomes."( Use of cannabidiol in anxiety and anxiety-related disorders.
Curren, Z; Deas, CM; Ennis, J; Skelley, JW,
)
0.13
" However, more studies with standardized approaches to dosing and clinical outcome measurements are needed to determine the appropriate dosing strategy for CBD and its place in therapy."( Use of cannabidiol in anxiety and anxiety-related disorders.
Curren, Z; Deas, CM; Ennis, J; Skelley, JW,
)
0.13
"Palliative medicine physicians are challenged by lack of guidance regarding effectiveness and dosing of cannabis products in the setting of their emerging popularity."( Tetrahydrocannabinol and Cannabidiol Use in an Outpatient Palliative Medicine Population.
Highet, BH; Johnson, PW; Kaur, JS; Lesser, ER, 2020
)
0.56
"We administered Cannabidiol (CBD) capsules in different dosages (starting dosage 100 mg up to 600 mg over 8 weeks) after unsuccessful treatment with antidepressants."( Cannabidiol treatment in an adolescent with multiple substance abuse, social anxiety and depression.
Felnhofer, A; Klier, CM; Kothgassner, OD; Laczkovics, C, 2021
)
0.62
" This study aims to establish the CBD dose-exposure relationship and to evaluate the effects of dosage forms, food, and doses on CBD absorption."( Model-Based Analysis of Cannabidiol Dose-Exposure Relationship and Bioavailability.
Lim, SY; Sharan, S; Woo, S, 2020
)
0.56
" Dosage form, food, and dose were assessed for covariation."( Model-Based Analysis of Cannabidiol Dose-Exposure Relationship and Bioavailability.
Lim, SY; Sharan, S; Woo, S, 2020
)
0.56
"The effects of doses, dosage forms, and feeding status on CBD pharmacokinetics were quantified and should be taken into consideration for dose optimization."( Model-Based Analysis of Cannabidiol Dose-Exposure Relationship and Bioavailability.
Lim, SY; Sharan, S; Woo, S, 2020
)
0.56
" The aim of this study was to assess the effects of repeated CBD dosing on haemodynamics."( The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.
England, TJ; O'Sullivan, SE; Sultan, SR, 2020
)
0.56
" Cardiovascular parameters were assessed at rest and in response to isometric exercise after acute and repeated dosing using Finometer®, Vicorder® and Duplex ultrasound."( The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.
England, TJ; O'Sullivan, SE; Sultan, SR, 2020
)
0.56
" Within the CBD group, repeated dosing reduced arterial stiffness by day 7 (pulse wave velocity; MD -0."( The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.
England, TJ; O'Sullivan, SE; Sultan, SR, 2020
)
0.56
" The reduction in arterial stiffness and improvements in endothelial function after repeated CBD dosing are findings that warrant further investigation in populations with vascular diseases."( The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.
England, TJ; O'Sullivan, SE; Sultan, SR, 2020
)
0.56
" Patients received plant-derived highly purified CBD in oral solution in addition to their baseline medications at an initial dosage of 5 mg/kg/day, which was increased by 5 mg/kg/day every week to an initial target dosage of 25 mg/kg/day."( Cannabidiol in treatment of refractory epileptic spasms: An open-label study.
Barnett, J; Bruno, P; Geffrey, AL; Herlopian, A; Hess, EJ; Pollack, SF; Skirvin, L; Sourbron, J; Thiele, EA, 2020
)
0.56
"The method fulfilled the criteria in terms of specificity, calibration curve, precision, trueness and dosing range."( Validation of an UHPLC/DAD method for the determination of cannabinoids in seized materials: Analysis of 213 samples sold in Belgian CBD shops.
Charlier, C; Denooz, R; Deville, M; Dubois, N, 2020
)
0.56
"6 mg Δ9-tetrahydrocannabinol (THC) in a randomized, placebo-controlled, within-subject dosing design."( Free and Glucuronide Urine Cannabinoids after Controlled Smoked, Vaporized and Oral Cannabis Administration in Frequent and Occasional Cannabis Users.
Abulseoud, OA; Andersson, M; Barnes, AJ; Blount, BC; Huestis, MA; Newmeyer, MN; Schroeder, J; Sempio, C; Smith, ML, 2020
)
0.56
" Those formulations which are approved are dosed several times a day, creating an unmet need for controlled release (CR) formulations of cannabinoids."( Investigation of cannabidiol gastro retentive tablets based on regional absorption of cannabinoids in rats.
Freidman, M; Hoffman, A; Izgelov, D, 2020
)
0.56
" Although detailed studies have not been published, the available data suggest that the absolute bioavailability of CBD after oral dosing under fasting conditions is approximately 6%, and increases fourfold when the medication is co-administered with a high-fat meal."( Critical Aspects Affecting Cannabidiol Oral Bioavailability and Metabolic Elimination, and Related Clinical Implications.
Bialer, M; Perucca, E, 2020
)
0.56
" The reasons behind this popularity is the compound's therapeutic properties, alongside a safe profile of administration lacking addictive properties such as euphoric state of mind and a wide dosing range."( Pharmacokinetic investigation of synthetic cannabidiol oral formulations in healthy volunteers.
Barasch, D; Davidson, E; Domb, AJ; Hoffman, A; Izgelov, D; Regev, A, 2020
)
0.56
"8 years; 7 male) performed fMRI Sternberg task before receiving CBD ("PRE") and after reaching stable dosage of CBD (15-25 mg/kg/day; "ON")."( Effects of highly purified cannabidiol (CBD) on fMRI of working memory in treatment-resistant epilepsy.
Allendorfer, JB; Bebin, EM; Gaston, TE; Grayson, LP; Martin, RC; Nair, S; Szaflarski, JP, 2020
)
0.56
" This allows for simultaneously printing an individual dose and encapsulating information relevant to the end-users and other stakeholders in a single dosage unit, which is readable by a standard smartphone."( Data-enriched edible pharmaceuticals (DEEP) of medical cannabis by inkjet printing.
Bøtker, J; Cornett, C; Frokjaer, S; Genina, N; Hansen, H; Öblom, H; Rades, T; Rantanen, J, 2020
)
0.56
" Dose-response relationships were calculated using Probit analysis and statistical significance was assessed with a two-sample z-test."( Cannabidiolic acid exhibits entourage-like improvements of anticonvulsant activity in an acute rat model of seizures.
Beenhakker, M; Goerl, B; Metcalf, C; Smith, M; Watkins, S, 2021
)
0.62
" Test compounds should be compared by sub-chronic dosing in the MES test in order to assess safety and pharmacokinetic profiles."( Cannabidiolic acid exhibits entourage-like improvements of anticonvulsant activity in an acute rat model of seizures.
Beenhakker, M; Goerl, B; Metcalf, C; Smith, M; Watkins, S, 2021
)
0.62
" The 25-mg/kg/day dosage had a better safety profile than the 50-mg/kg/day dosage."( Add-on Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex: A Placebo-Controlled Randomized Clinical Trial.
Bebin, EM; Bhathal, H; Checketts, D; Jansen, FE; Knappertz, V; Kotulska, K; Lawson, JA; O'Callaghan, FJ; Sahebkar, F; Thiele, EA; Wong, M, 2021
)
0.62
" Evidence in rodent models of EAE strongly supports CBD as effective, while clinical evidence is still limited and usually negative, due to paucity of studies and possibly to the use of suboptimal dosing regimens."( Immunomodulatory Potential of Cannabidiol in Multiple Sclerosis: a Systematic Review.
Cosentino, M; Ferrari, M; Furgiuele, A; Marino, F, 2021
)
0.62
" Data from this study show that for clinically meaningful efficacy against OA, CBD may have to be delivered in higher dosage or formulated with other medicinal plants with similar activities."( Antinociceptive and Anti-Inflammatory Properties of Cannabidiol Alone and in Combination with Standardized Bioflavonoid Composition.
Brownell, L; Hong, M; Horm, T; Jia, Q; Jiao, P; O'Neal, A; Rossiter, S; Yimam, M, 2021
)
0.62
" The bioavailability and pharmacokinetics of CBD are not well understood, and proper dosing schemes have not been adequately developed for its clinical use."( Food effects on the formulation, dosing, and administration of cannabidiol (CBD) in humans: A systematic review of clinical studies.
Capparelli, EV; Rosania, GR; Silmore, LH; Willmer, AR, 2021
)
0.62
"Daily high dosing with THC compromised performance on a task of cognition, and reduced activity in adolescent primates, with tolerance developing within weeks."( Effects of daily Δ
Bergman, J; Charles, S; Eisold, JE; George, SR; Gumbert, AB; Kangas, BD; Madras, BK; Withey, SL, 2021
)
0.62
"Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, decision-making surrounding appropriate dosing of cannabis used for medical purposes is limited."( Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.
Bonn-Miller, MO; Land, MH; MacNair, L; Mosesova, I; Peters, EN; Turcotte, C; Vandrey, R; Ware, MA, 2022
)
0.72
" Among the participants who had used or were using at least 1 CBD product, the most commonly used dosage form was sublingual, followed by topical: 46 (46/63 [73%]) and 34 (34/63 [54%]) participants, respectively."( Assessment of hemp oil-based cannabidiol use in a community-based pharmacy setting.
Gatewood, SS; Gicewicz, E; Goode, JR; Kaefer, TN; Nadpara, P,
)
0.13
"Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, informed physician and patient decision-making surrounding appropriate dosing of cannabis for medical purposes is limited."( Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Red Softgels in Healthy Participants.
Bonn-Miller, MO; Land, MH; MacNair, L; Mosesova, I; Peters, EN; Turcotte, C; Vandrey, R; Ware, MA, 2022
)
0.72
" In dose-response studies, adult, male CD1 mice were injected intraperitoneally with (1) CBD alone (0-96 mg/kg), (2) THC alone (0-6."( Effects of cannabidiol and Δ9-tetrahydrocannabinol in the elevated plus maze in mice.
Burnham, WM; Liu, J; Scott, BW, 2022
)
0.72
" There was no dose-response observed for CBD, suggesting a ceiling effect at the doses used and the potential for lower effective doses of CBD."( Cannabidiol reduces withdrawal symptoms in nicotine-dependent rats.
Boomhower, B; Carrette, LLG; Dowling, J; Fitzgerald, RL; George, O; Hanham, K; Hoffman, M; Kallupi, M; Momper, JD; Sepulveda, Y; Smith, LC; Suhandynata, RT; Tieu, L, 2021
)
0.62
"This pharmacokinetic (PK) drug-interaction trial investigated the effects of repeated dosing of a plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex in the United States and Epidyolex in Europe; 100 mg/mL oral solution) on caffeine clearance via modulation of cytochrome P450 (CYP) 1A2 activity in healthy adults."( A Phase 1 Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects.
Critchley, D; Tayo, B; Thai, C, 2021
)
0.62
" FDA authorization for the commercial use of four cannabinoid-derived products, available as oral dosage forms is a significant progress already."( Delivering therapeutic cannabinoids via skin: Current state and future perspectives.
Chukwunyere, UI; Frempong, D; Mishra, D; Puri, A; Thakur, D; Tijani, AO, 2021
)
0.62
"Medicinal cannabis is generally well tolerated when dosed appropriately."( A primer on medicinal cannabis safety and potential adverse effects.
Arnold, JC, 2021
)
0.62
" Risk mitigation strategies such as appropriate chemovar (strain) selection, routes of administration, and dosing are reviewed."( "Is medical cannabis safe for my patients?" A practical review of cannabis safety considerations.
Boivin, M; Lo, LA; MacCallum, CA, 2021
)
0.62
" Urine specimens were collected before and for 58 h after dosing on a residential research unit."( Urinary Pharmacokinetic Profile of Cannabidiol (CBD), Δ9-Tetrahydrocannabinol (THC) and Their Metabolites following Oral and Vaporized CBD and Vaporized CBD-Dominant Cannabis Administration.
Bigelow, GE; Cone, EJ; Flegel, RR; Goffi, E; Kuntz, D; Mitchell, JM; Sholler, DJ; Spindle, TR; Vandrey, R; Winecker, RE, 2022
)
0.72
" Our granular investigation reveals variability of CBD product dosing practices for fibromyalgia, and how past-year HTC use influences CBD product use."( Cannabidiol Product Dosing and Decision-Making in a National Survey of Individuals with Fibromyalgia.
Boehnke, KF; Gagnier, JJ; Matallana, L; Williams, DA, 2022
)
0.72
" This study presents a dose-response curve to understand better the effects of low doses (3 mg/kg) on CBD's antiallodynic and anxiolytic effects."( Cannabidiol effectively reverses mechanical and thermal allodynia, hyperalgesia, and anxious behaviors in a neuropathic pain model: Possible role of CB1 and TRPV1 receptors.
Crippa, JA; Garcia-Cairasco, N; Hallak, JE; Lazarini-Lopes, W; Leite-Panissi, CRA; Silva-Cardoso, GK; Zuardi, AW, 2021
)
0.62
"We demonstrate that commercial CBD products, especially aqueous beverages, can show inconsistent labeling, vary largely from their label claims should they make them, and show lot-to-lot variability making dosing unpredictable."( Analysis of cannabidiol (CBD) and THC in nonprescription consumer products: Implications for patients and practitioners.
Elder, EJ; Gidal, BE; Jones, KJ; Miller, OS, 2022
)
0.72
" Sigmoidal non-linear dose-response relationships are of grave concern."( Geotemporospatial and causal inference epidemiological analysis of US survey and overview of cannabis, cannabidiol and cannabinoid genotoxicity in relation to congenital anomalies 2001-2015.
Hulse, GK; Reece, AS, 2022
)
0.72
" This practical guide provides an overview of these main ASMs including their indications/contraindications, mechanism of action, efficacy, safety and tolerability profile, dosage requirements, and laboratory and clinical parameters to be evaluated."( A Practical Guide to the Treatment of Dravet Syndrome with Anti-Seizure Medication.
Schubert-Bast, S; Strzelczyk, A, 2022
)
0.72
" Our results showed that a well-designed CBD ocular dosage form can be stabilized for an extended shelf life."( The dose-dependent effect of a stabilized cannabidiol nanoemulsion on ocular surface inflammation and intraocular pressure.
Benita, S; Frušić-Zlotkin, M; Nassar, T; Ofri, R; Rebibo, L, 2022
)
0.72
" The aim of this study was to investigate similar dosing of CBG and CBGA from hemp plants that have been used for cannabidiol pharmacokinetic studies."( Single dose and chronic oral administration of cannabigerol and cannabigerolic acid-rich hemp extract in fed and fasted dogs: Physiological effect and pharmacokinetic evaluation.
Amstutz, K; Ellis, K; Gomez, B; Lyubimov, A; Schwark, WS; Venator, KP; Wakshlag, JJ; Zakharov, A, 2022
)
0.72
" Future research should focus on longer term symptom relief, including nausea-free intervals and dosing frequency; the risks of consumption of medical cannabis, especially among high-risk populations, such as pregnant women and children; and potential interactions between cannabis, conventional antiemetics, other medications, food, tobacco, alcohol, and street drugs among specific patient populations."( The Effectiveness of Common Cannabis Products for Treatment of Nausea.
Brockelman, F; Hall, B; Keeling, K; Li, X; Lopez, V; Orozco, J; Stith, SS; Vigil, JM, 2022
)
0.72
" CBD had dose-dependent, but variable, oral bioavailability at 1 mg/kg and 3 mg/kg daily dosing and was consistently detectable at steady state in synovial fluid at the higher dose."( Pharmacokinetics, Safety, and Synovial Fluid Concentrations of Single- and Multiple-Dose Oral Administration of 1 and 3 mg/kg Cannabidiol in Horses.
Contino, EK; Gustafson, DL; O'Fallon, ES; Yocom, AF, 2022
)
0.72
" We will begin with an overview of the legal and commercial environment, examine recent preclinical and clinical evidence on CBD, explore questions concerning CBD raised by healthcare professionals and patients, investigate dosing regimens and methods of administration, and address current challenges in the accumulation of sound evidence."( Cannabidiol (CBD) in Rheumatic Diseases (Musculoskeletal Pain).
Boehnke, KF; Fitzcharles, MA; Häuser, W, 2022
)
0.72
" Dosing for symptom relief has not yet been established."( Cannabidiol (CBD) in Rheumatic Diseases (Musculoskeletal Pain).
Boehnke, KF; Fitzcharles, MA; Häuser, W, 2022
)
0.72
" Future clinical trials may investigate different dosage regimens."( Cannabidiol enhancement of exposure therapy in treatment refractory patients with social anxiety disorder and panic disorder with agoraphobia: A randomised controlled trial.
Baas, JM; Batelaan, NM; Cath, DC; Duits, P; Eikelenboom, M; Groenink, L; Kwee, CM; Moerbeek, M; van Balkom, AJ; van der Flier, FE; van der Veen, DC, 2022
)
0.72
" CBD was fed relative to body mass at 0 (control), 30, 115, or 230 mg/Kg/day for 28 days; with 6 males and 6 females per dosing group."( Cannabidiol (CBD) Dosing: Plasma Pharmacokinetics and Effects on Accumulation in Skeletal Muscle, Liver and Adipose Tissue.
Child, RB; Tallon, MJ, 2022
)
0.72
" Management of the 260 DDIs detected included counseling only (89% [n = 232 interactions]), discontinuation of the interacting agent [9% (n = 22 interactions]), and dosage change for the interacting agent [2% (n = 6 interactions])."( Prescription cannabidiol for seizure disorder management: Initial drug-drug interaction management by specialty pharmacists.
Choi, L; DeClercq, J; Dial, H; Johnson, K; Owens, W; Shah, NB; Zuckerman, AD, 2022
)
0.72
" Analyzing the biological effects of CBD on MDA-MB-231, we have demonstrated that both CBD dosage and serum concentrations in the culture medium influence its outcomes; furthermore, light scattering studies demonstrated that serum impacts the CBD aggregation state by acting as a surfactant agent."( Cannabidiol Antiproliferative Effect in Triple-Negative Breast Cancer MDA-MB-231 Cells Is Modulated by Its Physical State and by IGF-1.
Ceriani, M; Costa, B; D'Aloia, A; Sacco, E; Stucchi, S; Tisi, R, 2022
)
0.72
"Concentrations of CBD and metabolites (7-COH CBD and 7-COOH CBD) were detected in all plasma samples up to 8 hours after dosing (oral and IV), with 7-COOH CBD being the most predominant metabolite."( Pharmacokinetics of cannabidiol in a randomized crossover trial in senior horses.
Adams, AA; Knych, HK; Turner, SE, 2022
)
0.72
" Further studies are currently ongoing to confirm dosing and effectiveness in other orthopaedic conditions."( Buccally Absorbed Cannabidiol Shows Significantly Superior Pain Control and Improved Satisfaction Immediately After Arthroscopic Rotator Cuff Repair: A Placebo-Controlled, Double-Blinded, Randomized Trial.
Alaia, MJ; Britton, B; Gonzalez-Lomas, G; Hurley, ET; Jazrawi, LM; Kaplan, K; Markus, DH; Rokito, AS; Vasavada, K, 2022
)
0.72
" These data may be useful in determining appropriate dosing of cannabinoids in the domestic rabbit."( Feeding decreases the oral bioavailability of cannabidiol and cannabidiolic acid in hemp oil in New Zealand White rabbits (Oryctolagus cuniculus).
Carpenter, JW; Gardhouse, SM; KuKanich, B; Magnin, GC; Rooney, TA; Tully, TN, 2022
)
0.72
" This continuing education article summarizes available efficacy and safety data involving cannabidiol, stiripentol, and fenfluramine and provides a practical review of dosing strategies, pharmacokinetics, and monitoring interventions relevant to their use."( Treatment-Refractory Dravet Syndrome: Considerations for Novel Medications.
Blackmer, AB; Lopez, JC; Orth, LE; Pare, JR,
)
0.13
" Heterogeneity in cannabis types, doses, timing of administration, and sleep outcome measures limit the ability to make specific dosing recommendations."( Cannabis dosing and administration for sleep: a systematic review.
Boerkoel, P; Cullen, K; Hawkins, M; Lai, WW; Malas, A; Roesler, J; Velzeboer, R, 2022
)
0.72
", dosage >12 sprays per day and/or not administered primarily for treatment of spasticity."( Effects of Sativex
Dykukha, I; Essner, U; Penner, IK; Raithel, LM; Schreiber, H, 2022
)
0.72
" Here we assessed CBD dose-response effects in the Genetically Epilepsy Prone Rats (GEPR-3) strain, which exhibits two types of epileptic seizures, brainstem-dependent generalized tonic-clonic seizures and limbic seizures."( Cannabidiol attenuates generalized tonic-clonic and suppresses limbic seizures in the genetically epilepsy-prone rats (GEPR-3) strain.
Campos-Rodriguez, C; Forcelli, PA; Garcia-Cairasco, N; Lazarini-Lopes, W; N'Gouemo, P, 2023
)
0.91
" Therefore, two different dose-response studies were performed, one for generalized tonic-clonic seizures and the other for limbic seizures."( Cannabidiol attenuates generalized tonic-clonic and suppresses limbic seizures in the genetically epilepsy-prone rats (GEPR-3) strain.
Campos-Rodriguez, C; Forcelli, PA; Garcia-Cairasco, N; Lazarini-Lopes, W; N'Gouemo, P, 2023
)
0.91
" Other factors, including dosage and clobazam co-therapy, were significantly associated with a greater effect on seizure control and side effects of CBD."( Clinical efficacy and safety of cannabidiol for pediatric refractory epilepsy indications: A systematic review and meta-analysis.
Aparasu, R; Estes, E; Reddy, DS; Talwar, A, 2023
)
0.91
" Randomized controlled canine trials with large sample sizes are needed to determine the range of therapeutic plasma concentrations, develop evidence-based dosing regimens, determine the efficacy of cannabidiol in drug-refractory epilepsy, and explore potential associations between treatment effects and different etiologies, epilepsy types, and drug combinations."( Cannabidiol in canine epilepsy.
Bhatti, SFM; McGrath, S; Potschka, H; Tipold, A, 2022
)
0.72
" Dosing guidelines to inform future human studies are however lacking."( Cannabidiol in clinical and preclinical anxiety research. A systematic review into concentration-effect relations using the IB-de-risk tool.
Baas, JM; Bongaerts, FL; Cath, DC; Groenink, L; Jacobs, G; Kwee, CM; van Gerven, JM, 2022
)
0.72
"A straightforward dosing recommendation was not possible, given variable concentration-effect relations across species, and no consistent linear effect of CBD on anxiety reduction."( Cannabidiol in clinical and preclinical anxiety research. A systematic review into concentration-effect relations using the IB-de-risk tool.
Baas, JM; Bongaerts, FL; Cath, DC; Groenink, L; Jacobs, G; Kwee, CM; van Gerven, JM, 2022
)
0.72
" While cannabidiol was generally safe and well tolerated even in high doses among the included studies, clearer dosing guidelines and increased regulation of cannabidiol products are also needed."( The Effectiveness and Safety of Cannabidiol in Non-seizure-related Indications: A Systematic Review of Published Randomized Clinical Trials.
Rudisill, TM; Tang, Y; Tonkovich, KL, 2022
)
0.72
" Eight cats were randomized into six dosing groups of four cats each."( Pharmacokinetics of escalating single-dose administration of cannabidiol to cats.
Bartner, LR; Castro, SC; Gustafson, DL; Kusick, BR; McGrath, S; Rozental, AJ, 2023
)
0.91
" Using currently available data, likely drug interactions of which prescribers of cannabidiol need to be aware, at the doses likely to cause clinically significant interactions, and drug dosing changes that may be needed are highlighted."( Cannabidiol drug interaction considerations for prescribers and pharmacists.
Graham, M; Lucas, CJ; Martin, JH; Murnion, B; Schneider, J, 2022
)
0.72
" For an individual patient, there are inherent limitations in providing clinical guidance due to gaps in specific drug dose-response data and knowledge of individual pharmacokinetic profiles, including different co-morbidities, and concurrent medicines."( Cannabidiol drug interaction considerations for prescribers and pharmacists.
Graham, M; Lucas, CJ; Martin, JH; Murnion, B; Schneider, J, 2022
)
0.72
" However, most use a mixture of CBD and the psychoactive, tetrahydrocannabinol (THC), and/or use variable dosing that is not consistent between individual patients."( Role of Cannabidiol for Improvement of the Quality of Life in Cancer Patients: Potential and Challenges.
Green, R; Khalil, R; Mohapatra, S; Mohapatra, SS, 2022
)
0.72
"" Reports that provided dosing regimens and patient outcomes were included."( Cannabidiol in refractory status epilepticus: A review of clinical experiences.
Duda, J; Reinert, JP, 2022
)
0.72
" Dosing of CBD ranged between 5-25 mg/kg/day and was titrated based on patient response to therapy."( Cannabidiol in refractory status epilepticus: A review of clinical experiences.
Duda, J; Reinert, JP, 2022
)
0.72
" Additional research is necessary to determine a definitive dosing strategy for this agent."( Cannabidiol in refractory status epilepticus: A review of clinical experiences.
Duda, J; Reinert, JP, 2022
)
0.72
" First, we determined the analgesic effect of CBD and BCP individually by establishing dose-response studies."( Cannabidiol and Beta-Caryophyllene in Combination: A Therapeutic Functional Interaction.
Benamar, K; Blanton, H; Duong, J; Yin, L, 2022
)
0.72
" Current literature poses the challenge that it does not provide standardized guidance on dosing for the above potential indications and cannabis use is dominated by recreational purposes."( Therapeutic and Supportive Effects of Cannabinoids in Patients with Brain Tumors (CBD Oil and Cannabis).
Butowski, N; Rodriguez-Almaraz, JE, 2023
)
0.91
" Overall, this study indicates that CBG is promising for developing a transdermal dosage for pain management."( The antinociceptive activity and mechanism of action of cannabigerol.
Li, R; Lin, G; Wang, Z; Wen, Y; Zhang, J; Zhang, R; Zhu, Y, 2023
)
0.91
"The goal of pharmacokinetic (PK) studies is to provide a basis for appropriate dosing regimens with novel therapeutic agents."( A One Health perspective on comparative cannabidiol and cannabidiolic acid pharmacokinetics and biotransformation in humans and domestic animals.
Schwark, WS; Wakshlag, JJ, 2023
)
0.91
" Additional studies are needed to determine the safe and effective CBD dosage for treating epilepsy."( Adverse Events of Cannabidiol Use in Patients With Epilepsy: A Systematic Review and Meta-analysis.
Fazlollahi, A; Gharagozli, K; Golabi, B; Kolahi, AA; Nejadghaderi, SA; Safiri, S; Sullman, MJM; Zahmatyar, M; ZareDini, M, 2023
)
0.91
" Maximum concentration and area under the concentration-time curve (AUC) from time of dosing to the last measurable concentration and extrapolated to infinity, of everolimus in whole blood were estimated using noncompartmental analysis, with geometric mean ratios and 90% confidence intervals for the ratios of everolimus dosed with CBD to everolimus dosed alone."( Pharmacokinetic Drug-Drug Interaction With Coadministration of Cannabidiol and Everolimus in a Phase 1 Healthy Volunteer Trial.
Berwaerts, J; Chen, C; Critchley, D; Hyland, K; Tayo, B; Thai, C; Wray, L, 2023
)
0.91
"We found heterogeneity regarding cannabidiol dosage and dosing frequency."( Assessment of cannabidiol use in pets according to a national survey in the USA.
Corsato Alvarenga, I; Duerr, F; Elam, LH; MacQuiddy, B; McGrath, S, 2023
)
0.91
" Age- and weight-based dosing of diazepam nasal spray were administered during a 12-month treatment period."( Concomitant cannabidiol does not impact safety and effectiveness of diazepam nasal spray for seizure clusters: Post hoc analysis of a phase 3 safety study.
Carrazana, E; Misra, SN; Peters, JM; Puri, V; Rabinowicz, AL; Segal, E, 2023
)
0.91
"2) days, with dosage escalating to twice per day."( Cognitive Safety Data from a Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9-Tetrahydrocannabinol Drug on Parkinson's Disease-Related Motor Symptoms.
Adkins, M; Bainbridge, J; Domen, CH; Klawitter, J; Leehey, MA; Liu, Y; Rajkovic, S; Sempio, C; Sillau, S, 2023
)
0.91
"Our findings indicate that acute dosing of cannabidiol over 24 h can lower blood pressure and arterial stiffness in individuals with untreated hypertension."( The Influence of Oral Cannabidiol on 24-h Ambulatory Blood Pressure and Arterial Stiffness in Untreated Hypertension: A Double-Blind, Placebo-Controlled, Cross-Over Pilot Study.
Brown, CV; Dragun, T; Dujić, Ž; Obad, A; Tulppo, MP, 2023
)
0.91
" Altogether, these results demonstrated that proliposomes may be a valuable intermediate for the preparation of deformable liposome-based cutaneous dosage forms, improving the stability without compromising the overall performances."( Micelles-in-Liposome Systems Obtained by Proliposomal Approach for Cannabidiol Delivery: Structural Features and Skin Penetration.
Casiraghi, A; Cilurzo, F; Del Favero, E; Franzè, S; Rama, F; Ricci, C, 2023
)
0.91
" A systematic pharmacokinetic study was performed to determine whether there are differences in the pharmacokinetic parameters and systemic exposure of CBD after oral dosing as an isolate, broad-spectrum, or full-spectrum product."( Comparative Pharmacokinetics of Commercially Available Cannabidiol Isolate, Broad-Spectrum, and Full-Spectrum Products.
Berthold, EC; Chiang, YH; Kamble, SH; Kanumuri, SRR; Kuntz, MA; McCurdy, CR; McMahon, LR; Senetra, AS; Sharma, A, 2023
)
0.91
" However, there is a significant need for more research that accurately reflects CBD dosing and administration regimens used in a real-world context."( Cannabidiol as a Harm Reduction Strategy for People Who Use Drugs: A Rapid Review.
Fehr, F; Koehn, M; Lo, LA; MacCallum, CA; Milloy, MJ; Mitchell, I; Nanson, K; Walsh, Z, 2023
)
0.91
"Results indicated no effect of acute CBD dosing on worry severity or anxiety symptoms."( The effects of cannabidiol on worry and anxiety among high trait worriers: a double-blind, randomized placebo controlled trial.
Bilsky, S; Ferretti, ML; Gournay, LR; Leen-Feldner, EW; Mann, E; Nguyen, AM; Vance, E; Williams, P, 2023
)
0.91
" Mouse proteome profiler cytokine/chemokine array revealed upregulation of complement C5/5a (anaphylatoxin), soluble intracellular adhesion molecule-1 (sICAM-1) and IL-1 receptor antagonist (IL-1RA) in animals dosed with β-CP (10 mg/mL)."( Epicutaneous Sensitization to the Phytocannabinoid β-Caryophyllene Induces Pruritic Inflammation.
Baltazar, CT; Inan, S; Javed, E; Nayak, AP; Peruggia, GA; Ward, SJ, 2023
)
0.91
" The 5 mg/kg/day dosage met futility requirements after 12 dogs, and a dosage of 9 mg/kg/day was used in the next 39 dogs."( The efficacy and safety of cannabidiol as adjunct treatment for drug-resistant idiopathic epilepsy in 51 dogs: A double-blinded crossover study.
Bartner, LR; Corsato Alvarenga, I; Gustafson, DL; Kusick, BR; McGrath, S; Rao, S; Rozental, AJ; Weisbeck, BG,
)
0.13
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
plant metaboliteAny eukaryotic metabolite produced during a metabolic reaction in plants, the kingdom that include flowering plants, conifers and other gymnosperms.
antimicrobial agentA substance that kills or slows the growth of microorganisms, including bacteria, viruses, fungi and protozoans.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
resorcinolsAny benzenediol in which the two hydroxy groups are meta to one another.
olefinic compoundAny organic molecular entity that contains at least one C=C bond.
phytocannabinoidA class of cannabinoid which are C21 terpenophenolic compounds isolated primarily from Cannabis sativa.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (3)

PathwayProteinsCompounds
cannabinoid biosynthesis122
CBD synthetic pathway08
Cannabinoid receptor signaling020

Protein Targets (45)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
PPM1D proteinHomo sapiens (human)Potency32.99930.00529.466132.9993AID1347411
Interferon betaHomo sapiens (human)Potency32.99930.00339.158239.8107AID1347411
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
AcetylcholinesteraseElectrophorus electricus (electric eel)IC50 (µMol)17.07000.00000.94539.9400AID1773262
L-lactate dehydrogenase A chainHomo sapiens (human)Ki24.00000.05003.76508.5000AID1782666
Cytochrome P450 1A1Homo sapiens (human)Ki0.16000.01200.94693.8000AID1692707
Cytochrome P450 1A2Homo sapiens (human)Ki2.69000.00561.15349.0000AID1692708
Cytochrome P450 2C11 Rattus norvegicus (Norway rat)Ki20.70000.00030.00030.0003AID1692721
Cytochrome P450 3A4Homo sapiens (human)Ki1.00000.00011.41629.9000AID1692724
Cytochrome P450 2D6Homo sapiens (human)Ki2.42000.00011.19868.0000AID1692723
Cytochrome P450 2A6Homo sapiens (human)Ki55.00000.00561.52717.5000AID1692718
Cytochrome P450 2C9 Homo sapiens (human)Ki5.60000.00031.684210.0000AID1692720
Fatty acid-binding protein, liverMus musculus (house mouse)Ki0.16700.02100.34832.0000AID1802031
Alpha-2B adrenergic receptorHomo sapiens (human)Ki3.20000.00020.725710.0000AID1692686
Alpha-2C adrenergic receptorHomo sapiens (human)Ki3.70000.00030.483410.0000AID1692688
Cannabinoid receptor 1Rattus norvegicus (Norway rat)Ki10.00000.00020.566510.0000AID260287
Cytochrome P450 2B6Homo sapiens (human)Ki0.69000.00041.416010.0000AID1692719
Cytochrome P450 3A5Homo sapiens (human)Ki0.19000.02202.60407.6000AID1692725
Cannabinoid receptor 1Homo sapiens (human)Ki3.13970.00010.50779.6000AID1127482; AID1625146; AID1692636; AID482748
D(1A) dopamine receptorHomo sapiens (human)Ki2.70000.00010.836310.0000AID1692684
Cytochrome P450 3A7Homo sapiens (human)Ki12.30000.02205.07407.6000AID1692726
5-hydroxytryptamine receptor 2CHomo sapiens (human)Ki1.10000.00010.954910.0000AID1692681
Cytochrome P450 2C19Homo sapiens (human)Ki0.79000.00010.830010.0000AID1692722
Cannabinoid receptor 2 Homo sapiens (human)Ki4.02300.00000.415610.0000AID1127483; AID1625147; AID1692637; AID482749
Mu-type opioid receptorHomo sapiens (human)Ki1.30000.00000.419710.0000AID1692682
Delta-type opioid receptorHomo sapiens (human)Ki6.40000.00000.59789.9300AID1692689
Kappa-type opioid receptorHomo sapiens (human)Ki2.30000.00000.362410.0000AID1692683
CholinesteraseEquus caballus (horse)IC50 (µMol)0.67000.00002.22149.4000AID1773260
N-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)IC50 (µMol)100.00000.70000.70000.7000AID1625159
Cytochrome P450 1B1Homo sapiens (human)Ki3.63000.00300.97417.4600AID1692709
Heat sensitive channel TRPV3Rattus norvegicus (Norway rat)IC50 (µMol)0.75000.75000.75000.7500AID1681222
Sigma intracellular receptor 2Homo sapiens (human)Ki3.40000.00010.83604.6005AID1692687
Transient receptor potential cation channel subfamily A member 1Rattus norvegicus (Norway rat)IC50 (µMol)0.45000.45003.42437.5000AID1681216
Transient receptor potential cation channel subfamily V member 1Homo sapiens (human)IC50 (µMol)3.70000.00020.606010.0000AID1681228
Transient receptor potential cation channel subfamily M member 8Rattus norvegicus (Norway rat)IC50 (µMol)2.80000.05802.65048.3000AID1681215
Transient receptor potential cation channel subfamily V member 4Rattus norvegicus (Norway rat)IC50 (µMol)5.90000.03701.45415.9000AID1681219
Transient receptor potential cation channel subfamily V member 2Rattus norvegicus (Norway rat)IC50 (µMol)1.10000.03701.93458.6000AID1681225
Diacylglycerol lipase-alphaHomo sapiens (human)IC50 (µMol)100.00000.00101.05385.0119AID1625150
Histamine H3 receptorHomo sapiens (human)Ki3.10000.00010.33998.5110AID1692685
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
5-hydroxytryptamine receptor 1AHomo sapiens (human)EC50 (µMol)8.00000.00010.25718.0000AID1692634
5-hydroxytryptamine receptor 2ARattus norvegicus (Norway rat)EC50 (µMol)32.00000.00010.49294.0000AID1692635
Caspase-1Homo sapiens (human)Kd0.01880.01880.01880.0188AID1780736
Cannabinoid receptor 2 Homo sapiens (human)EC50 (µMol)0.17910.00030.15173.2800AID1847100; AID1847103; AID1847106; AID1847108; AID1847114; AID1847121; AID1847127; AID1847131; AID1847133; AID1847137; AID1847139; AID1847145; AID1847151; AID1847158; AID1847162; AID1847164; AID1847168; AID1847169; AID1847171; AID1847177; AID1847183; AID1847189; AID1847193
Peroxisome proliferator-activated receptor gammaHomo sapiens (human)EC50 (µMol)25.00000.00000.992210.0000AID1657599
Heat sensitive channel TRPV3Rattus norvegicus (Norway rat)EC50 (µMol)0.51000.51000.51000.5100AID1681223
Transient receptor potential cation channel subfamily A member 1Rattus norvegicus (Norway rat)EC50 (µMol)0.28800.06002.22238.4000AID1681217; AID482146
Transient receptor potential cation channel subfamily V member 1Homo sapiens (human)EC50 (µMol)4.10000.00051.06746.3096AID1681229
Transient receptor potential cation channel subfamily V member 4Rattus norvegicus (Norway rat)EC50 (µMol)0.90000.03000.33150.9000AID1681220
Transient receptor potential cation channel subfamily V member 2Rattus norvegicus (Norway rat)EC50 (µMol)1.20000.03000.45071.7000AID1681226
G-protein coupled receptor 55Homo sapiens (human)EC50 (µMol)0.44500.00200.66622.0100AID482752
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Cannabinoid receptor 1Homo sapiens (human)Log Ki0.00360.00030.00190.0036AID49325
Cannabinoid receptor 2 Homo sapiens (human)Log Ki0.00350.00050.00200.0035AID49851
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (450)

Processvia Protein(s)Taxonomy
lactate metabolic processL-lactate dehydrogenase A chainHomo sapiens (human)
pyruvate metabolic processL-lactate dehydrogenase A chainHomo sapiens (human)
glycolytic processL-lactate dehydrogenase A chainHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
cellular response to organic cyclic compoundCytochrome P450 1A1Homo sapiens (human)
response to hypoxiaCytochrome P450 1A1Homo sapiens (human)
long-chain fatty acid metabolic processCytochrome P450 1A1Homo sapiens (human)
lipid hydroxylationCytochrome P450 1A1Homo sapiens (human)
fatty acid metabolic processCytochrome P450 1A1Homo sapiens (human)
steroid biosynthetic processCytochrome P450 1A1Homo sapiens (human)
porphyrin-containing compound metabolic processCytochrome P450 1A1Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 1A1Homo sapiens (human)
steroid metabolic processCytochrome P450 1A1Homo sapiens (human)
estrogen metabolic processCytochrome P450 1A1Homo sapiens (human)
amine metabolic processCytochrome P450 1A1Homo sapiens (human)
response to nematodeCytochrome P450 1A1Homo sapiens (human)
response to herbicideCytochrome P450 1A1Homo sapiens (human)
ethylene metabolic processCytochrome P450 1A1Homo sapiens (human)
coumarin metabolic processCytochrome P450 1A1Homo sapiens (human)
flavonoid metabolic processCytochrome P450 1A1Homo sapiens (human)
response to iron(III) ionCytochrome P450 1A1Homo sapiens (human)
insecticide metabolic processCytochrome P450 1A1Homo sapiens (human)
dibenzo-p-dioxin catabolic processCytochrome P450 1A1Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 1A1Homo sapiens (human)
response to foodCytochrome P450 1A1Homo sapiens (human)
response to lipopolysaccharideCytochrome P450 1A1Homo sapiens (human)
response to vitamin ACytochrome P450 1A1Homo sapiens (human)
response to immobilization stressCytochrome P450 1A1Homo sapiens (human)
vitamin D metabolic processCytochrome P450 1A1Homo sapiens (human)
retinol metabolic processCytochrome P450 1A1Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 1A1Homo sapiens (human)
9-cis-retinoic acid biosynthetic processCytochrome P450 1A1Homo sapiens (human)
camera-type eye developmentCytochrome P450 1A1Homo sapiens (human)
nitric oxide metabolic processCytochrome P450 1A1Homo sapiens (human)
response to arsenic-containing substanceCytochrome P450 1A1Homo sapiens (human)
digestive tract developmentCytochrome P450 1A1Homo sapiens (human)
tissue remodelingCytochrome P450 1A1Homo sapiens (human)
hydrogen peroxide biosynthetic processCytochrome P450 1A1Homo sapiens (human)
response to hyperoxiaCytochrome P450 1A1Homo sapiens (human)
maternal process involved in parturitionCytochrome P450 1A1Homo sapiens (human)
hepatocyte differentiationCytochrome P450 1A1Homo sapiens (human)
cellular response to copper ionCytochrome P450 1A1Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 1A1Homo sapiens (human)
positive regulation of G1/S transition of mitotic cell cycleCytochrome P450 1A1Homo sapiens (human)
response to 3-methylcholanthreneCytochrome P450 1A1Homo sapiens (human)
steroid catabolic processCytochrome P450 1A2Homo sapiens (human)
porphyrin-containing compound metabolic processCytochrome P450 1A2Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 1A2Homo sapiens (human)
cholesterol metabolic processCytochrome P450 1A2Homo sapiens (human)
estrogen metabolic processCytochrome P450 1A2Homo sapiens (human)
toxin biosynthetic processCytochrome P450 1A2Homo sapiens (human)
post-embryonic developmentCytochrome P450 1A2Homo sapiens (human)
alkaloid metabolic processCytochrome P450 1A2Homo sapiens (human)
regulation of gene expressionCytochrome P450 1A2Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 1A2Homo sapiens (human)
dibenzo-p-dioxin metabolic processCytochrome P450 1A2Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 1A2Homo sapiens (human)
lung developmentCytochrome P450 1A2Homo sapiens (human)
methylationCytochrome P450 1A2Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 1A2Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 1A2Homo sapiens (human)
retinol metabolic processCytochrome P450 1A2Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 1A2Homo sapiens (human)
cellular respirationCytochrome P450 1A2Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 1A2Homo sapiens (human)
hydrogen peroxide biosynthetic processCytochrome P450 1A2Homo sapiens (human)
oxidative demethylationCytochrome P450 1A2Homo sapiens (human)
cellular response to cadmium ionCytochrome P450 1A2Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 1A2Homo sapiens (human)
lipid hydroxylationCytochrome P450 3A4Homo sapiens (human)
lipid metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid catabolic processCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid metabolic processCytochrome P450 3A4Homo sapiens (human)
cholesterol metabolic processCytochrome P450 3A4Homo sapiens (human)
androgen metabolic processCytochrome P450 3A4Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A4Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A4Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 3A4Homo sapiens (human)
calcitriol biosynthetic process from calciolCytochrome P450 3A4Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D metabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D catabolic processCytochrome P450 3A4Homo sapiens (human)
retinol metabolic processCytochrome P450 3A4Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A4Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 3A4Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A4Homo sapiens (human)
oxidative demethylationCytochrome P450 3A4Homo sapiens (human)
behavioral fear response5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
gamma-aminobutyric acid signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of serotonin secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of vasoconstriction5-hydroxytryptamine receptor 1AHomo sapiens (human)
exploration behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of dopamine metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of hormone secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 1AHomo sapiens (human)
xenobiotic metabolic processCytochrome P450 2D6Homo sapiens (human)
steroid metabolic processCytochrome P450 2D6Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2D6Homo sapiens (human)
estrogen metabolic processCytochrome P450 2D6Homo sapiens (human)
coumarin metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid catabolic processCytochrome P450 2D6Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2D6Homo sapiens (human)
isoquinoline alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2D6Homo sapiens (human)
retinol metabolic processCytochrome P450 2D6Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2D6Homo sapiens (human)
negative regulation of bindingCytochrome P450 2D6Homo sapiens (human)
oxidative demethylationCytochrome P450 2D6Homo sapiens (human)
negative regulation of cellular organofluorine metabolic processCytochrome P450 2D6Homo sapiens (human)
arachidonic acid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2A6Homo sapiens (human)
steroid metabolic processCytochrome P450 2A6Homo sapiens (human)
coumarin metabolic processCytochrome P450 2A6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2A6Homo sapiens (human)
coumarin catabolic processCytochrome P450 2A6Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2A6Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C9 Homo sapiens (human)
steroid metabolic processCytochrome P450 2C9 Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2C9 Homo sapiens (human)
estrogen metabolic processCytochrome P450 2C9 Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C9 Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
urea metabolic processCytochrome P450 2C9 Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 2C9 Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C9 Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
amide metabolic processCytochrome P450 2C9 Homo sapiens (human)
icosanoid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
oxidative demethylationCytochrome P450 2C9 Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
MAPK cascadeAlpha-2B adrenergic receptorHomo sapiens (human)
angiogenesisAlpha-2B adrenergic receptorHomo sapiens (human)
regulation of vascular associated smooth muscle contractionAlpha-2B adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2B adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2B adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2B adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2B adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2B adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2B adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of blood pressureAlpha-2B adrenergic receptorHomo sapiens (human)
positive regulation of uterine smooth muscle contractionAlpha-2B adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2B adrenergic receptorHomo sapiens (human)
regulation of smooth muscle contractionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2C adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2C adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2C adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2C adrenergic receptorHomo sapiens (human)
xenobiotic metabolic processCytochrome P450 2B6Homo sapiens (human)
steroid metabolic processCytochrome P450 2B6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2B6Homo sapiens (human)
cellular ketone metabolic processCytochrome P450 2B6Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2B6Homo sapiens (human)
lipid hydroxylationCytochrome P450 3A5Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A5Homo sapiens (human)
steroid metabolic processCytochrome P450 3A5Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A5Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A5Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A5Homo sapiens (human)
retinol metabolic processCytochrome P450 3A5Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A5Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A5Homo sapiens (human)
oxidative demethylationCytochrome P450 3A5Homo sapiens (human)
positive regulation of acute inflammatory response to antigenic stimulusCannabinoid receptor 1Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerCannabinoid receptor 1Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayCannabinoid receptor 1Homo sapiens (human)
spermatogenesisCannabinoid receptor 1Homo sapiens (human)
axonal fasciculationCannabinoid receptor 1Homo sapiens (human)
response to nutrientCannabinoid receptor 1Homo sapiens (human)
memoryCannabinoid receptor 1Homo sapiens (human)
positive regulation of neuron projection developmentCannabinoid receptor 1Homo sapiens (human)
negative regulation of serotonin secretionCannabinoid receptor 1Homo sapiens (human)
positive regulation of fever generationCannabinoid receptor 1Homo sapiens (human)
negative regulation of fatty acid beta-oxidationCannabinoid receptor 1Homo sapiens (human)
regulation of synaptic transmission, GABAergicCannabinoid receptor 1Homo sapiens (human)
response to lipopolysaccharideCannabinoid receptor 1Homo sapiens (human)
negative regulation of mast cell activationCannabinoid receptor 1Homo sapiens (human)
negative regulation of dopamine secretionCannabinoid receptor 1Homo sapiens (human)
response to nicotineCannabinoid receptor 1Homo sapiens (human)
cannabinoid signaling pathwayCannabinoid receptor 1Homo sapiens (human)
response to cocaineCannabinoid receptor 1Homo sapiens (human)
glucose homeostasisCannabinoid receptor 1Homo sapiens (human)
positive regulation of apoptotic processCannabinoid receptor 1Homo sapiens (human)
response to ethanolCannabinoid receptor 1Homo sapiens (human)
negative regulation of action potentialCannabinoid receptor 1Homo sapiens (human)
negative regulation of blood pressureCannabinoid receptor 1Homo sapiens (human)
positive regulation of blood pressureCannabinoid receptor 1Homo sapiens (human)
regulation of insulin secretionCannabinoid receptor 1Homo sapiens (human)
regulation of synaptic transmission, glutamatergicCannabinoid receptor 1Homo sapiens (human)
maternal process involved in female pregnancyCannabinoid receptor 1Homo sapiens (human)
regulation of feeding behaviorCannabinoid receptor 1Homo sapiens (human)
regulation of penile erectionCannabinoid receptor 1Homo sapiens (human)
retrograde trans-synaptic signaling by endocannabinoidCannabinoid receptor 1Homo sapiens (human)
regulation of presynaptic cytosolic calcium ion concentrationCannabinoid receptor 1Homo sapiens (human)
trans-synaptic signaling by endocannabinoid, modulating synaptic transmissionCannabinoid receptor 1Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayCannabinoid receptor 1Homo sapiens (human)
regulation of metabolic processCannabinoid receptor 1Homo sapiens (human)
temperature homeostasisD(1A) dopamine receptorHomo sapiens (human)
conditioned taste aversionD(1A) dopamine receptorHomo sapiens (human)
behavioral fear responseD(1A) dopamine receptorHomo sapiens (human)
regulation of protein phosphorylationD(1A) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(1A) dopamine receptorHomo sapiens (human)
response to amphetamineD(1A) dopamine receptorHomo sapiens (human)
protein import into nucleusD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
activation of adenylate cyclase activityD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
synapse assemblyD(1A) dopamine receptorHomo sapiens (human)
memoryD(1A) dopamine receptorHomo sapiens (human)
mating behaviorD(1A) dopamine receptorHomo sapiens (human)
grooming behaviorD(1A) dopamine receptorHomo sapiens (human)
adult walking behaviorD(1A) dopamine receptorHomo sapiens (human)
visual learningD(1A) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(1A) dopamine receptorHomo sapiens (human)
astrocyte developmentD(1A) dopamine receptorHomo sapiens (human)
dopamine transportD(1A) dopamine receptorHomo sapiens (human)
transmission of nerve impulseD(1A) dopamine receptorHomo sapiens (human)
neuronal action potentialD(1A) dopamine receptorHomo sapiens (human)
dentate gyrus developmentD(1A) dopamine receptorHomo sapiens (human)
striatum developmentD(1A) dopamine receptorHomo sapiens (human)
cerebral cortex GABAergic interneuron migrationD(1A) dopamine receptorHomo sapiens (human)
positive regulation of cell migrationD(1A) dopamine receptorHomo sapiens (human)
peristalsisD(1A) dopamine receptorHomo sapiens (human)
operant conditioningD(1A) dopamine receptorHomo sapiens (human)
synaptic transmission, glutamatergicD(1A) dopamine receptorHomo sapiens (human)
regulation of dopamine metabolic processD(1A) dopamine receptorHomo sapiens (human)
vasodilationD(1A) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(1A) dopamine receptorHomo sapiens (human)
maternal behaviorD(1A) dopamine receptorHomo sapiens (human)
positive regulation of potassium ion transportD(1A) dopamine receptorHomo sapiens (human)
glucose importD(1A) dopamine receptorHomo sapiens (human)
habituationD(1A) dopamine receptorHomo sapiens (human)
sensitizationD(1A) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(1A) dopamine receptorHomo sapiens (human)
positive regulation of release of sequestered calcium ion into cytosolD(1A) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(1A) dopamine receptorHomo sapiens (human)
positive regulation of synaptic transmission, glutamatergicD(1A) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(1A) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
long-term synaptic potentiationD(1A) dopamine receptorHomo sapiens (human)
long-term synaptic depressionD(1A) dopamine receptorHomo sapiens (human)
cellular response to catecholamine stimulusD(1A) dopamine receptorHomo sapiens (human)
modification of postsynaptic structureD(1A) dopamine receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionD(1A) dopamine receptorHomo sapiens (human)
positive regulation of neuron migrationD(1A) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(1A) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
dopamine receptor signaling pathwayD(1A) dopamine receptorHomo sapiens (human)
lipid hydroxylationCytochrome P450 3A7Homo sapiens (human)
steroid biosynthetic processCytochrome P450 3A7Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A7Homo sapiens (human)
steroid metabolic processCytochrome P450 3A7Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A7Homo sapiens (human)
retinol metabolic processCytochrome P450 3A7Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A7Homo sapiens (human)
oxidative demethylationCytochrome P450 3A7Homo sapiens (human)
behavioral fear response5-hydroxytryptamine receptor 2CHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2CHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
locomotory behavior5-hydroxytryptamine receptor 2CHomo sapiens (human)
feeding behavior5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2CHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of nervous system process5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of appetite5-hydroxytryptamine receptor 2CHomo sapiens (human)
regulation of corticotropin-releasing hormone secretion5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of fat cell differentiation5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of calcium-mediated signaling5-hydroxytryptamine receptor 2CHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2CHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2CHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2CHomo sapiens (human)
cellular response to organic substanceCaspase-1Homo sapiens (human)
pattern recognition receptor signaling pathwayCaspase-1Homo sapiens (human)
proteolysisCaspase-1Homo sapiens (human)
apoptotic processCaspase-1Homo sapiens (human)
signal transductionCaspase-1Homo sapiens (human)
osmosensory signaling pathwayCaspase-1Homo sapiens (human)
protein autoprocessingCaspase-1Homo sapiens (human)
positive regulation of interleukin-1 beta productionCaspase-1Homo sapiens (human)
positive regulation of interleukin-18 productionCaspase-1Homo sapiens (human)
defense response to bacteriumCaspase-1Homo sapiens (human)
regulation of apoptotic processCaspase-1Homo sapiens (human)
positive regulation of canonical NF-kappaB signal transductionCaspase-1Homo sapiens (human)
positive regulation of cysteine-type endopeptidase activity involved in apoptotic processCaspase-1Homo sapiens (human)
icosanoid biosynthetic processCaspase-1Homo sapiens (human)
regulation of inflammatory responseCaspase-1Homo sapiens (human)
positive regulation of inflammatory responseCaspase-1Homo sapiens (human)
protein maturationCaspase-1Homo sapiens (human)
defense response to virusCaspase-1Homo sapiens (human)
pyroptosisCaspase-1Homo sapiens (human)
cellular response to lipopolysaccharideCaspase-1Homo sapiens (human)
cellular response to mechanical stimulusCaspase-1Homo sapiens (human)
cellular response to type II interferonCaspase-1Homo sapiens (human)
cytokine precursor processingCaspase-1Homo sapiens (human)
signaling receptor ligand precursor processingCaspase-1Homo sapiens (human)
AIM2 inflammasome complex assemblyCaspase-1Homo sapiens (human)
positive regulation of tumor necrosis factor-mediated signaling pathwayCaspase-1Homo sapiens (human)
long-chain fatty acid metabolic processCytochrome P450 2C19Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C19Homo sapiens (human)
steroid metabolic processCytochrome P450 2C19Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C19Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C19Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
response to amphetamineCannabinoid receptor 2 Homo sapiens (human)
inflammatory responseCannabinoid receptor 2 Homo sapiens (human)
immune responseCannabinoid receptor 2 Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerCannabinoid receptor 2 Homo sapiens (human)
leukocyte chemotaxisCannabinoid receptor 2 Homo sapiens (human)
negative regulation of synaptic transmission, GABAergicCannabinoid receptor 2 Homo sapiens (human)
response to lipopolysaccharideCannabinoid receptor 2 Homo sapiens (human)
negative regulation of mast cell activationCannabinoid receptor 2 Homo sapiens (human)
cannabinoid signaling pathwayCannabinoid receptor 2 Homo sapiens (human)
negative regulation of action potentialCannabinoid receptor 2 Homo sapiens (human)
regulation of metabolic processCannabinoid receptor 2 Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayCannabinoid receptor 2 Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMu-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
sensory perceptionMu-type opioid receptorHomo sapiens (human)
negative regulation of cell population proliferationMu-type opioid receptorHomo sapiens (human)
sensory perception of painMu-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
behavioral response to ethanolMu-type opioid receptorHomo sapiens (human)
positive regulation of neurogenesisMu-type opioid receptorHomo sapiens (human)
negative regulation of Wnt protein secretionMu-type opioid receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeMu-type opioid receptorHomo sapiens (human)
calcium ion transmembrane transportMu-type opioid receptorHomo sapiens (human)
cellular response to morphineMu-type opioid receptorHomo sapiens (human)
regulation of cellular response to stressMu-type opioid receptorHomo sapiens (human)
regulation of NMDA receptor activityMu-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayMu-type opioid receptorHomo sapiens (human)
negative regulation of gene expressionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of cholesterol effluxPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
long-chain fatty acid transportPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of osteoblast differentiationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of smooth muscle cell proliferationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of receptor signaling pathway via STATPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of low-density lipoprotein receptor activityPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of signaling receptor activityPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of gene expressionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of BMP signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of MAP kinase activityPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of adiponectin secretionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of miRNA transcriptionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of cardiac muscle hypertrophy in response to stressPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of connective tissue replacement involved in inflammatory response wound healingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of transcription by RNA polymerase IIPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
placenta developmentPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
regulation of transcription by RNA polymerase IIPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
lipid metabolic processPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
activation of cysteine-type endopeptidase activity involved in apoptotic processPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
signal transductionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
G protein-coupled receptor signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
response to nutrientPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
regulation of blood pressurePeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of gene expressionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of gene expressionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
macrophage derived foam cell differentiationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of macrophage derived foam cell differentiationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of cholesterol storagePeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of lipid storagePeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of sequestering of triglyceridePeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of angiogenesisPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
monocyte differentiationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
BMP signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
epithelial cell differentiationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
cellular response to insulin stimulusPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
response to lipidPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
peroxisome proliferator activated receptor signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
glucose homeostasisPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
regulation of circadian rhythmPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
mRNA transcription by RNA polymerase IIPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
lipoprotein transportPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of blood vessel endothelial cell migrationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
innate immune responsePeroxisome proliferator-activated receptor gammaHomo sapiens (human)
cell fate commitmentPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of fat cell differentiationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of DNA-templated transcriptionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of DNA-templated transcriptionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
retinoic acid receptor signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
cell maturationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
rhythmic processPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
white fat cell differentiationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of DNA-binding transcription factor activityPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
lipid homeostasisPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of type II interferon-mediated signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of SMAD protein signal transductionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
regulation of cholesterol transporter activityPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
cellular response to low-density lipoprotein particle stimulusPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
cellular response to hypoxiaPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of mitochondrial fissionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
regulation of cellular response to insulin stimulusPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of extracellular matrix assemblyPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of miRNA transcriptionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of miRNA transcriptionPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of cellular response to transforming growth factor beta stimulusPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of adipose tissue developmentPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of vascular associated smooth muscle cell proliferationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of vascular associated smooth muscle cell apoptotic processPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of vascular endothelial cell proliferationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
positive regulation of fatty acid metabolic processPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
fatty acid metabolic processPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
negative regulation of inflammatory responsePeroxisome proliferator-activated receptor gammaHomo sapiens (human)
cell differentiationPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
hormone-mediated signaling pathwayPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
immune responseDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerDelta-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
adult locomotory behaviorDelta-type opioid receptorHomo sapiens (human)
negative regulation of gene expressionDelta-type opioid receptorHomo sapiens (human)
negative regulation of protein-containing complex assemblyDelta-type opioid receptorHomo sapiens (human)
positive regulation of CREB transcription factor activityDelta-type opioid receptorHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationDelta-type opioid receptorHomo sapiens (human)
response to nicotineDelta-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
eating behaviorDelta-type opioid receptorHomo sapiens (human)
regulation of mitochondrial membrane potentialDelta-type opioid receptorHomo sapiens (human)
regulation of calcium ion transportDelta-type opioid receptorHomo sapiens (human)
cellular response to growth factor stimulusDelta-type opioid receptorHomo sapiens (human)
cellular response to hypoxiaDelta-type opioid receptorHomo sapiens (human)
cellular response to toxic substanceDelta-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayDelta-type opioid receptorHomo sapiens (human)
immune responseKappa-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
chemical synaptic transmissionKappa-type opioid receptorHomo sapiens (human)
sensory perceptionKappa-type opioid receptorHomo sapiens (human)
locomotory behaviorKappa-type opioid receptorHomo sapiens (human)
sensory perception of painKappa-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting opioid receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
response to insulinKappa-type opioid receptorHomo sapiens (human)
positive regulation of dopamine secretionKappa-type opioid receptorHomo sapiens (human)
negative regulation of luteinizing hormone secretionKappa-type opioid receptorHomo sapiens (human)
response to nicotineKappa-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
maternal behaviorKappa-type opioid receptorHomo sapiens (human)
eating behaviorKappa-type opioid receptorHomo sapiens (human)
response to estrogenKappa-type opioid receptorHomo sapiens (human)
estrous cycleKappa-type opioid receptorHomo sapiens (human)
response to ethanolKappa-type opioid receptorHomo sapiens (human)
regulation of saliva secretionKappa-type opioid receptorHomo sapiens (human)
behavioral response to cocaineKappa-type opioid receptorHomo sapiens (human)
sensory perception of temperature stimulusKappa-type opioid receptorHomo sapiens (human)
defense response to virusKappa-type opioid receptorHomo sapiens (human)
cellular response to lipopolysaccharideKappa-type opioid receptorHomo sapiens (human)
cellular response to glucose stimulusKappa-type opioid receptorHomo sapiens (human)
positive regulation of p38MAPK cascadeKappa-type opioid receptorHomo sapiens (human)
positive regulation of potassium ion transmembrane transportKappa-type opioid receptorHomo sapiens (human)
response to acrylamideKappa-type opioid receptorHomo sapiens (human)
positive regulation of eating behaviorKappa-type opioid receptorHomo sapiens (human)
conditioned place preferenceKappa-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayKappa-type opioid receptorHomo sapiens (human)
fatty acid metabolic processN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
sphingosine metabolic processN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
lipid catabolic processN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
N-acylethanolamine metabolic processN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
N-acylphosphatidylethanolamine metabolic processN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
cellular response to organic cyclic compoundCytochrome P450 1B1Homo sapiens (human)
angiogenesisCytochrome P450 1B1Homo sapiens (human)
trabecular meshwork developmentCytochrome P450 1B1Homo sapiens (human)
DNA modificationCytochrome P450 1B1Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 1B1Homo sapiens (human)
nitric oxide biosynthetic processCytochrome P450 1B1Homo sapiens (human)
cell adhesionCytochrome P450 1B1Homo sapiens (human)
response to nutrientCytochrome P450 1B1Homo sapiens (human)
steroid metabolic processCytochrome P450 1B1Homo sapiens (human)
estrogen metabolic processCytochrome P450 1B1Homo sapiens (human)
negative regulation of cell population proliferationCytochrome P450 1B1Homo sapiens (human)
male gonad developmentCytochrome P450 1B1Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to oxidative stressCytochrome P450 1B1Homo sapiens (human)
toxin metabolic processCytochrome P450 1B1Homo sapiens (human)
positive regulation of vascular endothelial growth factor productionCytochrome P450 1B1Homo sapiens (human)
positive regulation of smooth muscle cell migrationCytochrome P450 1B1Homo sapiens (human)
sterol metabolic processCytochrome P450 1B1Homo sapiens (human)
arachidonic acid metabolic processCytochrome P450 1B1Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 1B1Homo sapiens (human)
collagen fibril organizationCytochrome P450 1B1Homo sapiens (human)
adrenal gland developmentCytochrome P450 1B1Homo sapiens (human)
negative regulation of cell migrationCytochrome P450 1B1Homo sapiens (human)
negative regulation of NF-kappaB transcription factor activityCytochrome P450 1B1Homo sapiens (human)
response to follicle-stimulating hormoneCytochrome P450 1B1Homo sapiens (human)
response to estradiolCytochrome P450 1B1Homo sapiens (human)
negative regulation of cell adhesion mediated by integrinCytochrome P450 1B1Homo sapiens (human)
benzene-containing compound metabolic processCytochrome P450 1B1Homo sapiens (human)
retinol metabolic processCytochrome P450 1B1Homo sapiens (human)
retinal metabolic processCytochrome P450 1B1Homo sapiens (human)
positive regulation of apoptotic processCytochrome P450 1B1Homo sapiens (human)
blood vessel endothelial cell migrationCytochrome P450 1B1Homo sapiens (human)
endothelial cell migrationCytochrome P450 1B1Homo sapiens (human)
estrous cycleCytochrome P450 1B1Homo sapiens (human)
positive regulation of translationCytochrome P450 1B1Homo sapiens (human)
positive regulation of angiogenesisCytochrome P450 1B1Homo sapiens (human)
positive regulation of receptor signaling pathway via JAK-STATCytochrome P450 1B1Homo sapiens (human)
membrane lipid catabolic processCytochrome P450 1B1Homo sapiens (human)
response to arsenic-containing substanceCytochrome P450 1B1Homo sapiens (human)
blood vessel morphogenesisCytochrome P450 1B1Homo sapiens (human)
retinal blood vessel morphogenesisCytochrome P450 1B1Homo sapiens (human)
ganglion developmentCytochrome P450 1B1Homo sapiens (human)
cellular response to hydrogen peroxideCytochrome P450 1B1Homo sapiens (human)
cellular response to cAMPCytochrome P450 1B1Homo sapiens (human)
cellular response to tumor necrosis factorCytochrome P450 1B1Homo sapiens (human)
cellular response to luteinizing hormone stimulusCytochrome P450 1B1Homo sapiens (human)
cellular response to cortisol stimulusCytochrome P450 1B1Homo sapiens (human)
cellular response to progesterone stimulusCytochrome P450 1B1Homo sapiens (human)
response to dexamethasoneCytochrome P450 1B1Homo sapiens (human)
endothelial cell-cell adhesionCytochrome P450 1B1Homo sapiens (human)
response to indole-3-methanolCytochrome P450 1B1Homo sapiens (human)
cellular response to toxic substanceCytochrome P450 1B1Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 1B1Homo sapiens (human)
response to 3-methylcholanthreneCytochrome P450 1B1Homo sapiens (human)
regulation of reactive oxygen species metabolic processCytochrome P450 1B1Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCytochrome P450 1B1Homo sapiens (human)
positive regulation of DNA biosynthetic processCytochrome P450 1B1Homo sapiens (human)
regulation of cell growthSigma intracellular receptor 2Homo sapiens (human)
regulation of intracellular lipid transportSigma intracellular receptor 2Homo sapiens (human)
regulation of intracellular cholesterol transportSigma intracellular receptor 2Homo sapiens (human)
cholesterol homeostasisSigma intracellular receptor 2Homo sapiens (human)
positive regulation of wound healingSigma intracellular receptor 2Homo sapiens (human)
positive regulation of lipoprotein transportSigma intracellular receptor 2Homo sapiens (human)
thermoceptionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of transcription by RNA polymerase IITransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
fever generationTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
microglial cell activationTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
diet induced thermogenesisTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
peptide secretionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of systemic arterial blood pressureTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
lipid metabolic processTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cell surface receptor signaling pathwayTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
positive regulation of cytosolic calcium ion concentrationTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
chemosensory behaviorTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of heart rateTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of mitochondrial membrane potentialTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
glutamate secretionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calcium-mediated signalingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to heatTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
positive regulation of apoptotic processTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
response to peptide hormoneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
positive regulation of nitric oxide biosynthetic processTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
behavioral response to painTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
sensory perception of mechanical stimulusTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
detection of temperature stimulus involved in thermoceptionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
detection of temperature stimulus involved in sensory perception of painTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
detection of chemical stimulus involved in sensory perception of painTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
protein homotetramerizationTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
excitatory postsynaptic potentialTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
smooth muscle contraction involved in micturitionTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calcium ion transmembrane transportTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to alkaloidTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to ATPTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to tumor necrosis factorTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to acidic pHTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to temperature stimulusTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
negative regulation of establishment of blood-brain barrierTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calcium ion import across plasma membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
response to capsazepineTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
cellular response to nerve growth factor stimulusTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
G protein-coupled receptor signaling pathwayG-protein coupled receptor 55Homo sapiens (human)
activation of phospholipase C activityG-protein coupled receptor 55Homo sapiens (human)
positive regulation of Rho protein signal transductionG-protein coupled receptor 55Homo sapiens (human)
cannabinoid signaling pathwayG-protein coupled receptor 55Homo sapiens (human)
bone resorptionG-protein coupled receptor 55Homo sapiens (human)
negative regulation of osteoclast differentiationG-protein coupled receptor 55Homo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeG-protein coupled receptor 55Homo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayG-protein coupled receptor 55Homo sapiens (human)
monoacylglycerol biosynthetic processDiacylglycerol lipase-alphaHomo sapiens (human)
G protein-coupled glutamate receptor signaling pathwayDiacylglycerol lipase-alphaHomo sapiens (human)
neuroblast proliferationDiacylglycerol lipase-alphaHomo sapiens (human)
arachidonic acid metabolic processDiacylglycerol lipase-alphaHomo sapiens (human)
diacylglycerol catabolic processDiacylglycerol lipase-alphaHomo sapiens (human)
retrograde trans-synaptic signaling by endocannabinoidDiacylglycerol lipase-alphaHomo sapiens (human)
regulation of neuroinflammatory responseDiacylglycerol lipase-alphaHomo sapiens (human)
cannabinoid biosynthetic processDiacylglycerol lipase-alphaHomo sapiens (human)
neurotransmitter secretionHistamine H3 receptorHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayHistamine H3 receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerHistamine H3 receptorHomo sapiens (human)
chemical synaptic transmissionHistamine H3 receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayHistamine H3 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (136)

Processvia Protein(s)Taxonomy
L-lactate dehydrogenase activityL-lactate dehydrogenase A chainHomo sapiens (human)
protein bindingL-lactate dehydrogenase A chainHomo sapiens (human)
identical protein bindingL-lactate dehydrogenase A chainHomo sapiens (human)
cadherin bindingL-lactate dehydrogenase A chainHomo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
monooxygenase activityCytochrome P450 1A1Homo sapiens (human)
iron ion bindingCytochrome P450 1A1Homo sapiens (human)
protein bindingCytochrome P450 1A1Homo sapiens (human)
arachidonic acid monooxygenase activityCytochrome P450 1A1Homo sapiens (human)
oxidoreductase activityCytochrome P450 1A1Homo sapiens (human)
oxidoreductase activity, acting on diphenols and related substances as donorsCytochrome P450 1A1Homo sapiens (human)
flavonoid 3'-monooxygenase activityCytochrome P450 1A1Homo sapiens (human)
oxygen bindingCytochrome P450 1A1Homo sapiens (human)
enzyme bindingCytochrome P450 1A1Homo sapiens (human)
heme bindingCytochrome P450 1A1Homo sapiens (human)
Hsp70 protein bindingCytochrome P450 1A1Homo sapiens (human)
demethylase activityCytochrome P450 1A1Homo sapiens (human)
Hsp90 protein bindingCytochrome P450 1A1Homo sapiens (human)
aromatase activityCytochrome P450 1A1Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
long-chain fatty acid omega-hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
hydroperoxy icosatetraenoate dehydratase activityCytochrome P450 1A1Homo sapiens (human)
long-chain fatty acid omega-1 hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
monooxygenase activityCytochrome P450 1A2Homo sapiens (human)
iron ion bindingCytochrome P450 1A2Homo sapiens (human)
protein bindingCytochrome P450 1A2Homo sapiens (human)
electron transfer activityCytochrome P450 1A2Homo sapiens (human)
oxidoreductase activityCytochrome P450 1A2Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 1A2Homo sapiens (human)
enzyme bindingCytochrome P450 1A2Homo sapiens (human)
heme bindingCytochrome P450 1A2Homo sapiens (human)
demethylase activityCytochrome P450 1A2Homo sapiens (human)
caffeine oxidase activityCytochrome P450 1A2Homo sapiens (human)
aromatase activityCytochrome P450 1A2Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 1A2Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 1A2Homo sapiens (human)
hydroperoxy icosatetraenoate dehydratase activityCytochrome P450 1A2Homo sapiens (human)
monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
steroid bindingCytochrome P450 3A4Homo sapiens (human)
iron ion bindingCytochrome P450 3A4Homo sapiens (human)
protein bindingCytochrome P450 3A4Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A4Homo sapiens (human)
oxygen bindingCytochrome P450 3A4Homo sapiens (human)
enzyme bindingCytochrome P450 3A4Homo sapiens (human)
heme bindingCytochrome P450 3A4Homo sapiens (human)
vitamin D3 25-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
caffeine oxidase activityCytochrome P450 3A4Homo sapiens (human)
quinine 3-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1-alpha,25-dihydroxyvitamin D3 23-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
aromatase activityCytochrome P450 3A4Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1,8-cineole 2-exo-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
receptor-receptor interaction5-hydroxytryptamine receptor 1AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
monooxygenase activityCytochrome P450 2D6Homo sapiens (human)
iron ion bindingCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activityCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2D6Homo sapiens (human)
heme bindingCytochrome P450 2D6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
iron ion bindingCytochrome P450 2A6Homo sapiens (human)
coumarin 7-hydroxylase activityCytochrome P450 2A6Homo sapiens (human)
enzyme bindingCytochrome P450 2A6Homo sapiens (human)
heme bindingCytochrome P450 2A6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2A6Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2A6Homo sapiens (human)
monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
iron ion bindingCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
caffeine oxidase activityCytochrome P450 2C9 Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
aromatase activityCytochrome P450 2C9 Homo sapiens (human)
heme bindingCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C9 Homo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2B adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2B adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2B adrenergic receptorHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2C adrenergic receptorHomo sapiens (human)
alpha-2A adrenergic receptor bindingAlpha-2C adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2C adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2C adrenergic receptorHomo sapiens (human)
monooxygenase activityCytochrome P450 2B6Homo sapiens (human)
iron ion bindingCytochrome P450 2B6Homo sapiens (human)
testosterone 16-alpha-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
heme bindingCytochrome P450 2B6Homo sapiens (human)
testosterone 16-beta-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2B6Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2B6Homo sapiens (human)
monooxygenase activityCytochrome P450 3A5Homo sapiens (human)
iron ion bindingCytochrome P450 3A5Homo sapiens (human)
protein bindingCytochrome P450 3A5Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A5Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A5Homo sapiens (human)
oxygen bindingCytochrome P450 3A5Homo sapiens (human)
heme bindingCytochrome P450 3A5Homo sapiens (human)
aromatase activityCytochrome P450 3A5Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A5Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A5Homo sapiens (human)
cannabinoid receptor activityCannabinoid receptor 1Homo sapiens (human)
protein bindingCannabinoid receptor 1Homo sapiens (human)
identical protein bindingCannabinoid receptor 1Homo sapiens (human)
G protein-coupled receptor activityCannabinoid receptor 1Homo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via GsD(1A) dopamine receptorHomo sapiens (human)
G-protein alpha-subunit bindingD(1A) dopamine receptorHomo sapiens (human)
dopamine neurotransmitter receptor activityD(1A) dopamine receptorHomo sapiens (human)
protein bindingD(1A) dopamine receptorHomo sapiens (human)
heterotrimeric G-protein bindingD(1A) dopamine receptorHomo sapiens (human)
dopamine bindingD(1A) dopamine receptorHomo sapiens (human)
arrestin family protein bindingD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(1A) dopamine receptorHomo sapiens (human)
monooxygenase activityCytochrome P450 3A7Homo sapiens (human)
iron ion bindingCytochrome P450 3A7Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A7Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A7Homo sapiens (human)
oxygen bindingCytochrome P450 3A7Homo sapiens (human)
heme bindingCytochrome P450 3A7Homo sapiens (human)
all-trans retinoic acid 18-hydroxylase activityCytochrome P450 3A7Homo sapiens (human)
aromatase activityCytochrome P450 3A7Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A7Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A7Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A7Homo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
identical protein binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
1-(4-iodo-2,5-dimethoxyphenyl)propan-2-amine binding5-hydroxytryptamine receptor 2CHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2CHomo sapiens (human)
endopeptidase activityCaspase-1Homo sapiens (human)
cysteine-type endopeptidase activityCaspase-1Homo sapiens (human)
protein bindingCaspase-1Homo sapiens (human)
cysteine-type endopeptidase activator activity involved in apoptotic processCaspase-1Homo sapiens (human)
kinase bindingCaspase-1Homo sapiens (human)
cytokine bindingCaspase-1Homo sapiens (human)
identical protein bindingCaspase-1Homo sapiens (human)
CARD domain bindingCaspase-1Homo sapiens (human)
caspase bindingCaspase-1Homo sapiens (human)
monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
iron ion bindingCytochrome P450 2C19Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxygen bindingCytochrome P450 2C19Homo sapiens (human)
enzyme bindingCytochrome P450 2C19Homo sapiens (human)
heme bindingCytochrome P450 2C19Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
aromatase activityCytochrome P450 2C19Homo sapiens (human)
long-chain fatty acid omega-1 hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C19Homo sapiens (human)
protein bindingCannabinoid receptor 2 Homo sapiens (human)
cannabinoid receptor activityCannabinoid receptor 2 Homo sapiens (human)
G-protein alpha-subunit bindingMu-type opioid receptorHomo sapiens (human)
G protein-coupled receptor activityMu-type opioid receptorHomo sapiens (human)
beta-endorphin receptor activityMu-type opioid receptorHomo sapiens (human)
voltage-gated calcium channel activityMu-type opioid receptorHomo sapiens (human)
protein bindingMu-type opioid receptorHomo sapiens (human)
morphine receptor activityMu-type opioid receptorHomo sapiens (human)
G-protein beta-subunit bindingMu-type opioid receptorHomo sapiens (human)
neuropeptide bindingMu-type opioid receptorHomo sapiens (human)
transcription cis-regulatory region bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
transcription coregulator bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
nucleic acid bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
DNA bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
chromatin bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
double-stranded DNA bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
DNA-binding transcription factor activityPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
nuclear receptor activityPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
prostaglandin receptor activityPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
protein bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
zinc ion bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
enzyme bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
peptide bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
identical protein bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
sequence-specific DNA bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
nuclear retinoid X receptor bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
arachidonic acid bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
DNA binding domain bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
LBD domain bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
alpha-actinin bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
R-SMAD bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
E-box bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
STAT family protein bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
DNA-binding transcription factor bindingPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
G protein-coupled opioid receptor activityDelta-type opioid receptorHomo sapiens (human)
protein bindingDelta-type opioid receptorHomo sapiens (human)
receptor serine/threonine kinase bindingDelta-type opioid receptorHomo sapiens (human)
G protein-coupled enkephalin receptor activityDelta-type opioid receptorHomo sapiens (human)
neuropeptide bindingDelta-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor activityKappa-type opioid receptorHomo sapiens (human)
protein bindingKappa-type opioid receptorHomo sapiens (human)
receptor serine/threonine kinase bindingKappa-type opioid receptorHomo sapiens (human)
dynorphin receptor activityKappa-type opioid receptorHomo sapiens (human)
neuropeptide bindingKappa-type opioid receptorHomo sapiens (human)
hydrolase activity, acting on carbon-nitrogen (but not peptide) bondsN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
N-acylsphingosine amidohydrolase activityN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
fatty acid amide hydrolase activityN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
N-(long-chain-acyl)ethanolamine deacylase activityN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
ceramidase activityN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
DNA-binding transcription factor bindingN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
monooxygenase activityCytochrome P450 1B1Homo sapiens (human)
iron ion bindingCytochrome P450 1B1Homo sapiens (human)
protein bindingCytochrome P450 1B1Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 1B1Homo sapiens (human)
heme bindingCytochrome P450 1B1Homo sapiens (human)
aromatase activityCytochrome P450 1B1Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 1B1Homo sapiens (human)
hydroperoxy icosatetraenoate dehydratase activityCytochrome P450 1B1Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, NAD(P)H as one donor, and incorporation of one atom of oxygenCytochrome P450 1B1Homo sapiens (human)
protein bindingSigma intracellular receptor 2Homo sapiens (human)
oxysterol bindingSigma intracellular receptor 2Homo sapiens (human)
cholesterol bindingSigma intracellular receptor 2Homo sapiens (human)
transmembrane signaling receptor activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
extracellular ligand-gated monoatomic ion channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
voltage-gated calcium channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calcium channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
protein bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
calmodulin bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
ATP bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
intracellularly gated calcium channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
chloride channel regulator activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
phosphatidylinositol bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
identical protein bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
metal ion bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
phosphoprotein bindingTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
temperature-gated ion channel activityTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
G protein-coupled receptor activityG-protein coupled receptor 55Homo sapiens (human)
cannabinoid receptor activityG-protein coupled receptor 55Homo sapiens (human)
protein bindingDiacylglycerol lipase-alphaHomo sapiens (human)
metal ion bindingDiacylglycerol lipase-alphaHomo sapiens (human)
acylglycerol lipase activityDiacylglycerol lipase-alphaHomo sapiens (human)
lipoprotein lipase activityDiacylglycerol lipase-alphaHomo sapiens (human)
histamine receptor activityHistamine H3 receptorHomo sapiens (human)
G protein-coupled acetylcholine receptor activityHistamine H3 receptorHomo sapiens (human)
G protein-coupled serotonin receptor activityHistamine H3 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (71)

Processvia Protein(s)Taxonomy
nucleusL-lactate dehydrogenase A chainHomo sapiens (human)
cytosolL-lactate dehydrogenase A chainHomo sapiens (human)
membraneL-lactate dehydrogenase A chainHomo sapiens (human)
extracellular exosomeL-lactate dehydrogenase A chainHomo sapiens (human)
oxidoreductase complexL-lactate dehydrogenase A chainHomo sapiens (human)
mitochondrionL-lactate dehydrogenase A chainHomo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
mitochondrial inner membraneCytochrome P450 1A1Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 1A1Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1A1Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 1A2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1A2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1A2Homo sapiens (human)
cytoplasmCytochrome P450 3A4Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A4Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A4Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
synapse5-hydroxytryptamine receptor 1AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 1AHomo sapiens (human)
mitochondrionCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulumCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2D6Homo sapiens (human)
cytoplasmCytochrome P450 2D6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2A6Homo sapiens (human)
cytoplasmic microtubuleCytochrome P450 2A6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2A6Homo sapiens (human)
cytoplasmCytochrome P450 2A6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C9 Homo sapiens (human)
plasma membraneCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
cytoplasmCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
cytosolAlpha-2B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2B adrenergic receptorHomo sapiens (human)
cell surfaceAlpha-2B adrenergic receptorHomo sapiens (human)
intracellular membrane-bounded organelleAlpha-2B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2B adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-2C adrenergic receptorHomo sapiens (human)
endosomeAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2B6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2B6Homo sapiens (human)
cytoplasmCytochrome P450 2B6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A5Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A5Homo sapiens (human)
mitochondrial outer membraneCannabinoid receptor 1Homo sapiens (human)
plasma membraneCannabinoid receptor 1Homo sapiens (human)
actin cytoskeletonCannabinoid receptor 1Homo sapiens (human)
growth coneCannabinoid receptor 1Homo sapiens (human)
presynaptic membraneCannabinoid receptor 1Homo sapiens (human)
membrane raftCannabinoid receptor 1Homo sapiens (human)
glutamatergic synapseCannabinoid receptor 1Homo sapiens (human)
GABA-ergic synapseCannabinoid receptor 1Homo sapiens (human)
plasma membraneCannabinoid receptor 1Homo sapiens (human)
cytoplasmCannabinoid receptor 1Homo sapiens (human)
nucleusD(1A) dopamine receptorHomo sapiens (human)
endoplasmic reticulum membraneD(1A) dopamine receptorHomo sapiens (human)
plasma membraneD(1A) dopamine receptorHomo sapiens (human)
ciliumD(1A) dopamine receptorHomo sapiens (human)
presynaptic membraneD(1A) dopamine receptorHomo sapiens (human)
dendritic spineD(1A) dopamine receptorHomo sapiens (human)
postsynaptic membraneD(1A) dopamine receptorHomo sapiens (human)
ciliary membraneD(1A) dopamine receptorHomo sapiens (human)
non-motile ciliumD(1A) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(1A) dopamine receptorHomo sapiens (human)
GABA-ergic synapseD(1A) dopamine receptorHomo sapiens (human)
G protein-coupled receptor complexD(1A) dopamine receptorHomo sapiens (human)
plasma membraneD(1A) dopamine receptorHomo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A7Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2CHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2CHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2CHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2CHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2CHomo sapiens (human)
cytoplasmCaspase-1Homo sapiens (human)
cytosolCaspase-1Homo sapiens (human)
nucleolusCaspase-1Homo sapiens (human)
cytoplasmCaspase-1Homo sapiens (human)
cytosolCaspase-1Homo sapiens (human)
microtubuleCaspase-1Homo sapiens (human)
plasma membraneCaspase-1Homo sapiens (human)
canonical inflammasome complexCaspase-1Homo sapiens (human)
NLRP1 inflammasome complexCaspase-1Homo sapiens (human)
NLRP3 inflammasome complexCaspase-1Homo sapiens (human)
AIM2 inflammasome complexCaspase-1Homo sapiens (human)
protein-containing complexCaspase-1Homo sapiens (human)
IPAF inflammasome complexCaspase-1Homo sapiens (human)
protease inhibitor complexCaspase-1Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C19Homo sapiens (human)
plasma membraneCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
cytoplasmCytochrome P450 2C19Homo sapiens (human)
plasma membraneCannabinoid receptor 2 Homo sapiens (human)
dendriteCannabinoid receptor 2 Homo sapiens (human)
extrinsic component of cytoplasmic side of plasma membraneCannabinoid receptor 2 Homo sapiens (human)
perikaryonCannabinoid receptor 2 Homo sapiens (human)
endoplasmic reticulumCannabinoid receptor 2 Homo sapiens (human)
plasma membraneCannabinoid receptor 2 Homo sapiens (human)
cytoplasmCannabinoid receptor 2 Homo sapiens (human)
endosomeMu-type opioid receptorHomo sapiens (human)
endoplasmic reticulumMu-type opioid receptorHomo sapiens (human)
Golgi apparatusMu-type opioid receptorHomo sapiens (human)
plasma membraneMu-type opioid receptorHomo sapiens (human)
axonMu-type opioid receptorHomo sapiens (human)
dendriteMu-type opioid receptorHomo sapiens (human)
perikaryonMu-type opioid receptorHomo sapiens (human)
synapseMu-type opioid receptorHomo sapiens (human)
plasma membraneMu-type opioid receptorHomo sapiens (human)
neuron projectionMu-type opioid receptorHomo sapiens (human)
nucleusPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
nucleusPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
nucleoplasmPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
cytosolPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
intracellular membrane-bounded organellePeroxisome proliferator-activated receptor gammaHomo sapiens (human)
RNA polymerase II transcription regulator complexPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
chromatinPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
receptor complexPeroxisome proliferator-activated receptor gammaHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
synaptic vesicle membraneDelta-type opioid receptorHomo sapiens (human)
dendrite membraneDelta-type opioid receptorHomo sapiens (human)
presynaptic membraneDelta-type opioid receptorHomo sapiens (human)
axon terminusDelta-type opioid receptorHomo sapiens (human)
spine apparatusDelta-type opioid receptorHomo sapiens (human)
postsynaptic density membraneDelta-type opioid receptorHomo sapiens (human)
neuronal dense core vesicleDelta-type opioid receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
neuron projectionDelta-type opioid receptorHomo sapiens (human)
nucleoplasmKappa-type opioid receptorHomo sapiens (human)
mitochondrionKappa-type opioid receptorHomo sapiens (human)
cytosolKappa-type opioid receptorHomo sapiens (human)
plasma membraneKappa-type opioid receptorHomo sapiens (human)
membraneKappa-type opioid receptorHomo sapiens (human)
sarcoplasmic reticulumKappa-type opioid receptorHomo sapiens (human)
T-tubuleKappa-type opioid receptorHomo sapiens (human)
dendriteKappa-type opioid receptorHomo sapiens (human)
synaptic vesicle membraneKappa-type opioid receptorHomo sapiens (human)
presynaptic membraneKappa-type opioid receptorHomo sapiens (human)
perikaryonKappa-type opioid receptorHomo sapiens (human)
axon terminusKappa-type opioid receptorHomo sapiens (human)
postsynaptic membraneKappa-type opioid receptorHomo sapiens (human)
plasma membraneKappa-type opioid receptorHomo sapiens (human)
neuron projectionKappa-type opioid receptorHomo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
cytoplasmN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
lysosomeN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
membraneN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
lysosomal lumenN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
extracellular exosomeN-acylethanolamine-hydrolyzing acid amidaseHomo sapiens (human)
mitochondrionCytochrome P450 1B1Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 1B1Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1B1Homo sapiens (human)
endoplasmic reticulumSigma intracellular receptor 2Homo sapiens (human)
lysosomeSigma intracellular receptor 2Homo sapiens (human)
endoplasmic reticulumSigma intracellular receptor 2Homo sapiens (human)
rough endoplasmic reticulumSigma intracellular receptor 2Homo sapiens (human)
plasma membraneSigma intracellular receptor 2Homo sapiens (human)
rough endoplasmic reticulum membraneSigma intracellular receptor 2Homo sapiens (human)
nuclear membraneSigma intracellular receptor 2Homo sapiens (human)
plasma membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
external side of plasma membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
dendritic spine membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
neuronal cell bodyTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
postsynaptic membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
plasma membraneTransient receptor potential cation channel subfamily V member 1Homo sapiens (human)
plasma membraneG-protein coupled receptor 55Homo sapiens (human)
plasma membraneG-protein coupled receptor 55Homo sapiens (human)
plasma membraneDiacylglycerol lipase-alphaHomo sapiens (human)
early endosome membraneDiacylglycerol lipase-alphaHomo sapiens (human)
dendrite membraneDiacylglycerol lipase-alphaHomo sapiens (human)
dendritic spine membraneDiacylglycerol lipase-alphaHomo sapiens (human)
varicosityDiacylglycerol lipase-alphaHomo sapiens (human)
postsynaptic density membraneDiacylglycerol lipase-alphaHomo sapiens (human)
dendrite membraneDiacylglycerol lipase-alphaHomo sapiens (human)
cytoplasmDiacylglycerol lipase-alphaHomo sapiens (human)
postsynaptic membraneDiacylglycerol lipase-alphaHomo sapiens (human)
plasma membraneHistamine H3 receptorHomo sapiens (human)
presynapseHistamine H3 receptorHomo sapiens (human)
plasma membraneHistamine H3 receptorHomo sapiens (human)
synapseHistamine H3 receptorHomo sapiens (human)
dendriteHistamine H3 receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (366)

Assay IDTitleYearJournalArticle
AID1692729Anti-seizure activity in Lennox-Gastaut patient assessed as median percent reduction in seizure frequency at 20 mg/kg administered daily for 14 weeks (Rvb = 17%)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692668Inhibition of D2 dopamine receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID132300The difference between the preinjection and postinjection (60 min) temperatures in mice was evaluated at a dose 100 mg/kg1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Hashish: synthesis and central nervous system activity of some novel analogues of cannabidiol and oxepin derivatives of delta 9-tetrahydrocannabinol.
AID1847167Partial agonist activity at wild type CB2 receptor (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1847162Partial agonist activity at wild type CB2 receptor (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths by DMR assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692675Inhibition of D1 dopamine receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692712Half-life in human at 10 mg/kg, po BID administered for 6 weeks measured weekly for 15 weeks by GC/MS analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692660Inhibition of muscarinic acetylcholine receptor M2 (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1303157Displacement of [3H]CP 55940 from human recombinant CB1 receptor expressed in CHO cell membranes at 10 uM after 120 mins by scintillation counting analysis2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID482748Displacement of [3H]CP-55940 from human cannabinoid CB1 receptor expressed in CHO cells2010Journal of medicinal chemistry, Jun-10, Volume: 53, Issue:11
Emerging targets in osteoporosis disease modification.
AID1692731Drug degradation in simulated gastric fluid at 40 mg incubated for 2 hrs by UPLC-MS analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1625146Displacement of [3H]-CP55940 from recombinant human CB1 receptor expressed in Sf9 cell membranes co-expressing Galphai3beta1gamma2 measured after 90 mins by scintillation counting method2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1847133Partial agonist activity at wild type CB2 receptor (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1303156Therapeutic index, ratio of TC50 for rat hippocampal neurons to EC50 for protection against ammonium acetate induced toxicity in rat hippocampal neurons after 5 hrs by carboxyfluorescein diacetate based fluorimetric analysis2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1193125Induction of rat TRPV3 expressed in HEK293 cells assessed as increase of Ca2+ level relative to ionomycin2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1780730Downregulation of IL-1beta mRNA expression in H2O2- stimulated human HaCaT cells at 10 uM incubated for 6 hrs by SPE based fluorescence amplification assay relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692690Critical aggregation concentration of compound by dynamic light scattering2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847171Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692709Competitive inhibition of human recombinant CYP1B1 using 7-Ethoxyresorufin as substrate by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847130Partial agonist activity at CBR2 S2857.39L mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HTR2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1660158Inhibition of NLRP3 inflammasome activation in LPS-stimulated human THP1 cells assessed as reduction in IL-1beta secretion at 10 uM incubated for 1 hr followed by nigericin addition and measured after 1 hr by ELISA relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1692671Inhibition of histamine H2 receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847127Partial agonist activity at CBR2 S2857.39L mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HTR2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1863994Protective index, ratio of TD50 for toxicity in CD-1 seizure mouse model assessed as effect on motor coordination administered ip measured after 0.5 hrs for 3 mins by rotarod test to ED50 for antiseizure activity against ScPTZ-induced seizure in ip dosed
AID1681222Antagonist activity at rat TRPV3 expressed in HEK293 cells assessed as inhibition of thymol-induced Ca2+ response preincubated for 5 mins followed by thymol addition by Fluo-4AM dye based fluorescence assay2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1847168Positive allosteric modulation of JWH-133-induced agonist activity at wild type CB2 receptor (unknown origin) stably expressed in HEK293T cells assessed as inhibition of forskolin-stimulated cAMP levels preincubated for 15 mins followed by forskolin addit2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1762670Cytotoxicity against mouse BV-2 cells assessed as reduction in cell viability incubated for 24 hrs in presence of DHA by crystal violet dye based assay2021Bioorganic & medicinal chemistry, 06-01, Volume: 39Cannabidiol-dihydroartemisinin conjugates for ameliorating neuroinflammation with reduced cytotoxicity.
AID1762668Cytotoxicity against mouse BV-2 cells assessed as reduction in cell viability incubated for 24 hrs by crystal violet dye based assay2021Bioorganic & medicinal chemistry, 06-01, Volume: 39Cannabidiol-dihydroartemisinin conjugates for ameliorating neuroinflammation with reduced cytotoxicity.
AID362542Antibacterial activity against macrolide-resistant Staphylococcus aureus RN4220 after 18 hrs2008Journal of natural products, Aug, Volume: 71, Issue:8
Antibacterial cannabinoids from Cannabis sativa: a structure-activity study.
AID1780731Inhibition of caspase-1 activity in H2O2-stimulated human HaCaT cells assessed as reduction in enzyme activity at 10 uM using YUAD-Pna as a substrate measured after 2 hrs by colorimetric assay relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692658Inhibition of PBR (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692685Inhibition of histamine H3 receptor (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1863986Toxicity in CD-1 seizure mouse model assessed as effect on motor coordination administered ip measured after 1 hrs for 3 mins by rotarod test
AID1303162Apparent permeability from apical to basolateral side in MDCK cells expressing MDR12016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1625162Inhibition of [14C]-AEA uptake in rat RBL2H3 cells by scintillation counting method2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1692707Competitive inhibition of human recombinant CYP1A1 using 7-Ethoxyresorufin as substrate by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692697Cmax in human plasma at 3.5 +/- 5.5 mg, INH2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1681229Agonist activity at human TRPV1 stably transfected in HEK293 cells assessed as increase in calcium influx in presence of ionomycin by Fluo-4-AM dye based spectrofluorimetric method2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1773264Permeability of the compound at 100 ug/ml incubated for 18 hrs by PAMPA2021European journal of medicinal chemistry, Nov-05, Volume: 223Novel cannabidiol-carbamate hybrids as selective BuChE inhibitors: Docking-based fragment reassembly for the development of potential therapeutic agents against Alzheimer's disease.
AID133447Compound was evaluated for the maximum possible effect in tail-flick test in mice at dose 50 mg/kg; Not tested1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Hashish: synthesis and central nervous system activity of some novel analogues of cannabidiol and oxepin derivatives of delta 9-tetrahydrocannabinol.
AID1660156Inhibition of NLRP3 inflammasome activation in LPS-stimulated human THP1 cells assessed as reduction in IL-1beta secretion at 0.1 uM incubated for 1 hr followed by nigericin addition and measured after 1 hr by ELISA relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1692682Inhibition of mu-type opioid receptor (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847172Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths by DMR assay relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1193126Induction of rat TRPV3 expressed in HEK293 cells assessed as increase of Ca2+ level2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1847183Partial agonist activity at CBR2 A2827.36M mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1847103Partial agonist activity at wild type CB2 receptor (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HT2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1524907Cytotoxicity against human SH-SY5Y cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1692664Inhibition of D3 dopamine receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692676Inhibition of histamine H3 receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1681219Antagonist activity at rat TRPV4 expressed in HEK293 cells assessed as inhibition of GSK1016790A-induced Ca2+ response preincubated for 5 mins followed by GSK1016790A addition by Fluo-4AM dye based fluorescence assay2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1625155Inhibition of MAGL in African green monkey COS cell homogenates at 50 uM using [3H]-arachidonoylglycerol as substrate measured after 20 mins by scintillation counting method relative to control2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1524901Cytotoxicity against human HCT116 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1780722Cytoprotective activity against H2O2-induced oxidative stress in human HaCaT cells assessed as change in cellular ROS level at 10 uM incubated for 6 hrs followed by H2O2 stimulation measured after 24 hrs by DCF-DA dye based fluorescence analysis (Rvb = 8.2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692679Inhibition of alpha2C receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID362543Antibacterial activity against tetracycline-resistant Staphylococcus aureus XU212 after 18 hrs2008Journal of natural products, Aug, Volume: 71, Issue:8
Antibacterial cannabinoids from Cannabis sativa: a structure-activity study.
AID1692726Mixed type inhibition of human recombinant CYP3A7 expressed in baculovirus-infected insect cells using diltiazem as substrate incubated for 30 mins followed by NADPH-generating system addition by Michaelis-Menten plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692693Cmax in human plasma at 14+/- 15 mg, po2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692722Mixed type inhibition of human recombinant CYP2C19 using (S)-mephenytoin as substrate preincubated for 5 mins followed by NADPH-generating system addition measured after 40 mins by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692727Mixed type inhibition of CYP17 in Sprague-Dawley rat testis microsomes assessed as reduction in 17alpha-Hydroxylase activity in presence of NADPH-generating system incubated for 2 mins by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID482749Displacement of [3H]CP-55940 from human cannabinoid CB2 receptor expressed in CHO cells2010Journal of medicinal chemistry, Jun-10, Volume: 53, Issue:11
Emerging targets in osteoporosis disease modification.
AID1625157Inhibition of FAAH in rat brain membranes at 50 uM using [14C]-AEA as substrate measured after 30 mins by scintillation counting method relative to control2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1660161Modulation of P2X7 receptor in nigericin-stimulated human THP1 cells assessed as intracellular potassium efflux at 10 uM incubated for 30 mins followed by 1 uM nigericin challenge and measured after 30 mins by Green-2 AM dye based flow cytometric analysis2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1692716Elimination rate constant in human at 20 mg using aerosol spray measured for 6 weeks2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1863977Antiseizure activity against electrical stimulus induced seizure in ip dosed CD-1 mouse model assessed as reduction in hindlimb tonic extension pretreated for 1 hr by maximal electroshock seizure test
AID1692674Inhibition of kappa-type opioid receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1193113Reduction of lecithin content in Niemann-Pick patient fibroblast at 30 uM2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1692657Inhibition of rat brain BZP at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847101Partial agonist activity at wild type CB2 receptor (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins by HTRF assay relative to co2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1780737Binding affinity to recombinant human caspase-1 assessed as association constant measured after 60 sec by SPR method2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692672Inhibition of 5-HT2C (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692684Inhibition of D1 dopamine receptor (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1660150Cytotoxicity against human THP1 cells assessed as cell viability at 100 uM after 24 hrs by CellTiter-Glo luminescent cell viability assay relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1847165Partial agonist activity at wild type CB2 receptor (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths by DMR assay relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692659Inhibition of alpha1D receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1524912Cytotoxicity against human PC3 cells assessed as reduction in cell viability incubated for 24 to 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1692717Elimination rate constant in human at 20 mg using nebulizer measured for 6 weeks2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1625156Inhibition of FAAH in rat brain membranes using [14C]-AEA as substrate measured after 30 mins by scintillation counting method2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1692713Apparent oral clearance in human at 5 to 20 mg using oromucosal-spray formulation by GC-MS analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID49491Binding affinity for Cannabinoid receptor 1 by the ability to displace radiolabeled CP-55940 from purified rat forebrain synaptosomes2002Bioorganic & medicinal chemistry letters, Dec-16, Volume: 12, Issue:24
Novel 1',1'-chain substituted Delta(8)-tetrahydrocannabinols.
AID1863998Antiseizure activity against electrical stimulus induced seizure in ip dosed CD-1 mouse model assessed as normal behavior within 10 seconds after stimulation at 6 Hz and 44 mA for 3 secs pretreated for 1 hr by psychomotor seizure test
AID1127484Selectivity ratio of Ki for human CB1 receptor to Ki for human CB2 receptor2013Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21
Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID260287Displacement of [3H]HU243 from CB1 receptor in Sabra rat brain2006Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3
New cannabidiol derivatives: synthesis, binding to cannabinoid receptor, and evaluation of their antiinflammatory activity.
AID1303151Neuroprotective activity in rat hippocampal neurons assessed as protection against ethanol induced cell death by measuring neuronal viability after 5 hrs by carboxyfluorescein diacetate dye based fluorimetric analysis2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1692705Elimination half-life in human at 10 mg, po using PTL401 formulation measured upto 24 hrs by LC-MS/MS assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847145Partial agonist activity at CBR2 V361.35M mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1762669Antiinflammatory activity in mouse BV-2 cells assessed as reduction in LPS-induced nitric oxide production incubated for 24 hrs in presence of DHA by 2, 3-diaminonaphthalene based assay2021Bioorganic & medicinal chemistry, 06-01, Volume: 39Cannabidiol-dihydroartemisinin conjugates for ameliorating neuroinflammation with reduced cytotoxicity.
AID362544Antibacterial activity against methicillin-resistant Staphylococcus aureus ATCC 25923 after 18 hrs2008Journal of natural products, Aug, Volume: 71, Issue:8
Antibacterial cannabinoids from Cannabis sativa: a structure-activity study.
AID1780733Anti-pyroptosis activity in human HaCaT cells assessed as reduction in H2O2-induced LDH production at 1 uM incubated for 6 hrs followed by H2O2 stimulation measured after 24 hrs by LDH assay relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1681217Agonist activity at rat TRPA1 stably transfected in HEK293 cells assessed as increase in calcium influx in presence of allylisothiocyanate by Fluo-4-AM dye based spectrofluorimetric method2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1692706Elimination half-life in human at 10 mg using oromucosal-spray formulation measured upto 24 hrs by LC-MS/MS assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692689Inhibition of delta-type opioid receptor receptor (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1660155Antiinflammatory activity in human THP1 cells assessed as reduction in LPS-induced IL-1beta secretion at 0.1 to 10 uM incubated for 1 hr followed by LPS stimulation and measured after 24 hrs by ELISA2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID482746Induction of bone formation in GPR55 knockout male mouse assessed as increase in tibia mass volume2010Journal of medicinal chemistry, Jun-10, Volume: 53, Issue:11
Emerging targets in osteoporosis disease modification.
AID1692691Protein binding in human plasma incubated for 20 to 24 hrs2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1780717Effect on cell cycle distribution in human HaCaT cells assessed as accumulation of cells at S phase at 10 uM pretreated for 6 hrs followed by H2O2 challenge for 24 hrs by propidium iodide staining based flow cytometry analysis (Rvb= 28.1%)2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1847106Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins by HTRF assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692695Cmax in human plasma at 525 +/- 340 mg, po2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692635Displacement of [3H] ketanserin from rat 5-HT2aR expressed in mouse NIH/3T3 cells incubated for 30 mins by liquid scintillation counting method2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692651Inhibition of 5-HT2B (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID49852Binding affinity for Cannabinoid receptor 2 by the ability to displace radiolabeled CP-55940 from mouse spleen synaptosomes2002Bioorganic & medicinal chemistry letters, Dec-16, Volume: 12, Issue:24
Novel 1',1'-chain substituted Delta(8)-tetrahydrocannabinols.
AID362541Antibacterial activity against methicillin-resistant Staphylococcus aureus SA1199B after 18 hrs2008Journal of natural products, Aug, Volume: 71, Issue:8
Antibacterial cannabinoids from Cannabis sativa: a structure-activity study.
AID1692728Toxicity in pig assessed as mean arterial blood pressure drop at 50 mg/kg, iv administered for 15 mins by pulse oximetry relative to baseline2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692654Inhibition of alpha1B receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847136Partial agonist activity at wild type CB2 receptor (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1252767Cytotoxicity against cdkn2a/TRPV1 doubly deficient PDGFB amplified mouse neurosphere glioma cells using bis-AAF-R110 as substrate at 10 uM preincubated for 24 hrs followed by substrate addition measured after 2 hrs by fluorescence analysis2015European journal of medicinal chemistry, Oct-20, Volume: 103Wittig derivatization of sesquiterpenoid polygodial leads to cytostatic agents with activity against drug resistant cancer cells and capable of pyrrolylation of primary amines.
AID1681221Agonist activity at rat TRPV4 stably transfected in HEK293 cells assessed as increase in calcium influx by Fluo-4-AM dye based spectrofluorimetric method relative to ionomycin2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1780734Anti-pyroptosis activity in human HaCaT cells assessed as reduction in H2O2-induced LDH production at 10 uM incubated for 6 hrs followed by H2O2 stimulation measured after 24 hrs by LDH assay relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692636Displacement of [3H]CP-55,940 from human CB1 receptor expressed in CHO cells incubated for 1 hr by liquid scintillation spectrometry2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1625150Inhibition of recombinant human DAGLalpha expressed in COS7 cells using [14C]-oleoyl-2-arachidonoyl-glycerol as substrate measured after 20 mins by beta-counting method2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1847131Partial agonist activity at wild type CB2 receptor (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins by AlphaScreenSureFire method2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID243998Inhibitory potency against fatty acid amide hydrolase activity in mouse brain microsomes in presence of 58 uM anandamide at 160 uM2005Journal of medicinal chemistry, Aug-11, Volume: 48, Issue:16
The endocannabinoid system: drug targets, lead compounds, and potential therapeutic applications.
AID167511Number of rabbits convulsed at 15 mg/kg, iv out of 7 rabbits tested1982Journal of medicinal chemistry, May, Volume: 25, Issue:5
Use of a potential rabbit model for structure--behavioral activity studies of cannabinoids.
AID1193123Antiinflammatory activity in human glial cells assessed as reduction of LPS-induced nitrate expression at 1 uM2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1252765Cytotoxicity against cdkn2a-deficient EGFRvIII amplified mouse neurosphere glioma cells using bis-AAF-R110 as substrate at 10 uM preincubated for 24 hrs followed by substrate addition measured after 2 hrs by fluorescence analysis2015European journal of medicinal chemistry, Oct-20, Volume: 103Wittig derivatization of sesquiterpenoid polygodial leads to cytostatic agents with activity against drug resistant cancer cells and capable of pyrrolylation of primary amines.
AID1660149Cytotoxicity against human THP1 cells assessed as cell viability at 10 uM after 24 hrs by CellTiter-Glo luminescent cell viability assay relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1193120Reduction of IL-1beta release in C57BL/6J mouse hippocampus inoculated with human amyloid beta (1 to 42) at 10 ug/kg, ip after 10 days by ELISA2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1847152Positive allosteric modulation of JWH-133-induced agonist activity at wild type CB2 receptor (unknown origin) stably expressed in HEK293T cells assessed as inhibition of forskolin-stimulated cAMP levels preincubated for 15 mins followed by forskolin addit2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692719Mixed type inhibition of human recombinant CYP2B6 expressed in baculovirus-infected insect cells using coumarin as substrate preincubated for 5 mins followed by NADPH-generating system addition by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1524908Cytotoxicity against human HCT116 cells assessed as reduction in cell viability incubated for 24 to 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1660159Inhibition of NLRP3 inflammasome activation in LPS-stimulated human THP1 cells assessed as IL-1beta secretion at 10 uM incubated for 1 hr followed by nigericin addition and measured after 1 hr by ELISA relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1303161Efflux ratio of permeability from basolateral to apical over apical to basolateral side in human Caco cells2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1692647Inhibition of alpha1A receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID132313The difference between the preinjection and postinjection (60 min) temperatures in mice was evaluated at a dose 75 mg/kg1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Hashish: synthesis and central nervous system activity of some novel analogues of cannabidiol and oxepin derivatives of delta 9-tetrahydrocannabinol.
AID1780735Antiapoptotic activity in human HaCaT cells assessed as reduction in apoptotic cells at 10 uM incubated for 6 hrs followed by H2O2 stimulation measured after 24 hrs by Mitotracker red/annexin V double staining based flow cytometry analysis (Rvb= 12.1%)2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692663Inhibition of beta-2 adrenergic receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1524904Cytotoxicity against human MCF7 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1847105Partial agonist activity at wild type CB2 receptor (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HT2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1524905Cytotoxicity against human PC3 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID49325Binding affinity towards cloned human Cannabinoid receptor 12000Journal of medicinal chemistry, Jun-15, Volume: 43, Issue:12
A 3D-QSAR study on the structural requirements for binding to CB(1) and CB(2) cannabinoid receptors.
AID1692673Inhibition of mu-type opioid receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID482752Binding affinity to GPR552010Journal of medicinal chemistry, Jun-10, Volume: 53, Issue:11
Emerging targets in osteoporosis disease modification.
AID130160Compound was evaluated for the percent antagonism in tail-flick test in mice at dose 40 mg/kg1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Hashish: synthesis and central nervous system activity of some novel analogues of cannabidiol and oxepin derivatives of delta 9-tetrahydrocannabinol.
AID1692694Tmax in human plasma at 525 +/- 340 mg, po2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1681230Agonist activity at human TRPV1 stably transfected in HEK293 cells assessed as increase in calcium influx by Fluo-4-AM dye based spectrofluorimetric method relative to ionomycin2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID362546Antibacterial activity against epidemic methicillin-resistant Staphylococcus aureus 16 after 18 hrs2008Journal of natural products, Aug, Volume: 71, Issue:8
Antibacterial cannabinoids from Cannabis sativa: a structure-activity study.
AID167517Number of rabbits convulsed at 20 mg/kg, iv out of 6 rabbits tested1982Journal of medicinal chemistry, May, Volume: 25, Issue:5
Use of a potential rabbit model for structure--behavioral activity studies of cannabinoids.
AID1524911Cytotoxicity against human MCF7 cells assessed as reduction in cell viability incubated for 24 to 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1692669Inhibition of histamine H1 receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1681216Antagonist activity at rat TRPA1 expressed in HEK293 cells assessed as inhibition of allylisothiocyanate-induced Ca2+ response preincubated for 5 mins followed by allylisothiocyanate addition by Fluo-4AM dye based fluorescence assay2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1847553Metabolic stability in rat liver microsomes assessed as intrinsic clearance2021European journal of medicinal chemistry, Dec-15, Volume: 226Carbon-silicon switch led to the discovery of novel synthetic cannabinoids with therapeutic effects in a mouse model of multiple sclerosis.
AID1782665Inhibition of human LDHB assessed as reduction in lactate production using pyruvate as substrate at 10 uM in presence of NADH by spectrophotometric analysis relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabichromene and Δ
AID1692661Inhibition of 5-HT1B (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID260282Ability to suppress nitric acid production by LPS-activated peritoneal macrophages form C57BL/6 mice at 4 ug/ml2006Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3
New cannabidiol derivatives: synthesis, binding to cannabinoid receptor, and evaluation of their antiinflammatory activity.
AID1193122Antiinflammatory activity in human glial cells assessed as reduction of LPS-induced iNOS expression at 1 uM2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID130147Spontaneous activity in mice at a dose 40 mg/kg1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Hashish: synthesis and central nervous system activity of some novel analogues of cannabidiol and oxepin derivatives of delta 9-tetrahydrocannabinol.
AID1681227Agonist activity at rat TRPV2 stably transfected in HEK293 cells assessed as increase in calcium influx by Fluo-4-AM dye based spectrofluorimetric method relative to ionomycin2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1681224Agonist activity at rat TRPV3 stably transfected in HEK293 cells assessed as increase in calcium influx by Fluo-4-AM dye based spectrofluorimetric method relative to ionomycin2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1681226Agonist activity at rat TRPV2 stably transfected in HEK293 cells assessed as increase in calcium influx in presence of ionomycin by Fluo-4-AM dye based spectrofluorimetric method2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1660148Cytotoxicity against human THP1 cells assessed as cell viability at 1 uM after 24 hrs by CellTiter-Glo luminescent cell viability assay relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1524914Cytotoxicity against human SH-SY5Y cells assessed as reduction in cell viability incubated for 24 to 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1780736Binding affinity to recombinant human caspase-1 assessed as dissociation constant measured after 90 sec by SPR method2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1625147Displacement of [3H]-CP55940 from recombinant human CB2 receptor expressed in Sf9 cell membranes co-expressing Galphai3beta1gamma2 measured after 90 mins by scintillation counting method2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1847148Partial agonist activity at CBR2 V361.35M mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1830992Inhibition of Beta-hematin in Plasmodium falciparum cells assessed as hemozoin formation after 32 hrs by NP40 detergent-mediated assay2021Bioorganic & medicinal chemistry letters, 12-15, Volume: 54THC shows activity against cultured Plasmodium falciparum.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1681215Antagonist activity at rat TRPM8 expressed in HEK293 cells assessed as inhibition of icilin-induced Ca2+ response preincubated for 5 mins followed by icilin addition by Fluo-4AM dye based fluorescence assay2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID482753Antiosteoporotic activity in mouse assessed as decrease in bone resorption-associated serum CTX-1 level at 10 mg/kg administered 3 times a week for 8 weeks2010Journal of medicinal chemistry, Jun-10, Volume: 53, Issue:11
Emerging targets in osteoporosis disease modification.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1649358Anti-seizure activity in ip dosed CF1 mouse assessed as attenuation of psychomotor seizures at stimulus intensities of 42 mA at pre-treated at 1 hr before test by 6 Hz limbic seizure test relative to control
AID1847177Partial agonist activity at CBR2 V361.35M mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1847117Partial agonist activity at CBR2 V361.35M mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HTRF2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692653Inhibition of DRD4 (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1657599Agonist activity at GAL4-tagged PPARgamma (unknown origin) transiently expressed in HEK293T cells co-transfected with GAL4-tagged luc incubated for 6 hrs by dual luciferase reporter gene assay2020Journal of natural products, 05-22, Volume: 83, Issue:5
The Oxidation of Phytocannabinoids to Cannabinoquinoids.
AID1692637Displacement of [3H]CP-55,940 from human CB2 receptor expressed in CHO cells incubated for 1 hr by liquid scintillation spectrometry2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1193117Reduction of iNOS protein expression in C57BL/6J mouse hippocampus inoculated with human amyloid beta (1 to 42) at 10 ug/kg, ip after 10 days by immunofluorescence analysis2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1847158Partial agonist activity at CBR2 S2857.39L mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692632Inhibition of 5-HT7A (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID165405Capability to induce convulsions in tetrahydrocannabinol-seizure susceptible (THC-SS) rabbit1982Journal of medicinal chemistry, May, Volume: 25, Issue:5
Use of a potential rabbit model for structure--behavioral activity studies of cannabinoids.
AID1692639Inhibition of H4 receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692662Inhibition of DAT (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1681228Antagonist activity at human TRPV1 expressed in HEK293 cells assessed as inhibition of capsaicin-induced Ca2+ response preincubated for 5 mins followed by capsaicin addition by Fluo-4AM dye based fluorescence assay2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1773252Cytotoxicity against human L02 cells assessed as cell viability at 50 uM incubated for 24 hrs by MTT assay2021European journal of medicinal chemistry, Nov-05, Volume: 223Novel cannabidiol-carbamate hybrids as selective BuChE inhibitors: Docking-based fragment reassembly for the development of potential therapeutic agents against Alzheimer's disease.
AID1847109Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins by HTRF assay relative to con2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1780727Antioxidant activity in human HaCaT cells assessed as reduction in mitochondria-derived ROS production by measuring mean fluorescence intensity at 10 uM preincubated for 6 hrs followed by H2O2 stimulation at 400 uM measured after 24 hrs by mitoSOX stainin2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID482146Agonist activity at rat TRPA1 channel expressed in HEK293 cells assessed as increase in intracellular calcium influx2010Journal of medicinal chemistry, Jul-22, Volume: 53, Issue:14
Transient receptor potential ankyrin 1 (TRPA1) channel as emerging target for novel analgesics and anti-inflammatory agents.
AID227699Virtual screen for compounds with anticonvulsant activity2003Bioorganic & medicinal chemistry letters, Aug-18, Volume: 13, Issue:16
Topological virtual screening: a way to find new anticonvulsant drugs from chemical diversity.
AID1692634Displacement of [3H]8-OH-DPAT from human 5-HT1a receptor expressed in CHO cells incubated for 30 mins by liquid scintillation counting method2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1780713Cytotoxicity against human HaCaT cells assessed as cell viability at 1 to 10 uM incubated for 24 hrs followed by H2O2 stimulation by celltiter-glo assay relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1625163Inhibition of [14C]-AEA uptake in rat RBL2H3 cells at 25 uM by scintillation counting method relative to control2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1692701Apparent oral volume of distribution in human at 5 to 20 mg using oromucosal-spray formulation administered for 9 days cotreated with THC by GC-MS analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847169Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths by DMR assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692714Apparent oral clearance in human in fed state at 5 to 20 mg using oromucosal-spray formulation cotreated with THC by GC-MS analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID260280Ability to suppress the production of reactive oxygen intermediates by activated RAW 264.7 macrophages from BALB/c mice at 4 ug/ml2006Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3
New cannabidiol derivatives: synthesis, binding to cannabinoid receptor, and evaluation of their antiinflammatory activity.
AID1660154Antiinflammatory activity in LPS-induced human THP1 cells assessed as IL-1beta secretion at 10 uM incubated for 1 hr followed by LPS stimulation and measured after 24 hrs by ELISA (Rvb = 51.2 pg/mL)2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1692710Half-life in human at 20 mg, iv measured after 0.05 to 72 hrs by gas chromatograph mass spectrometry2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1863993Protective index, ratio of TD50 for toxicity in CD-1 seizure mouse model assessed as effect on motor coordination administered ip measured after 0.5 hrs for 3 mins by rotarod test to ED50 for antiseizure activity against electrical stimulus induced seizur
AID1692628Plasma concentration in human at 100 mg/kg, po2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692633Inhibition of 5-HT2A (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847137Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins by AlphaScreenSureFire method2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID260283Ability to suppress nitric acid production by LPS-activated peritoneal macrophages form C57BL/6 mice at 8 ug/ml2006Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3
New cannabidiol derivatives: synthesis, binding to cannabinoid receptor, and evaluation of their antiinflammatory activity.
AID1780715Effect on cell cycle distribution in human HaCaT cells assessed as <2N cells at 10 uM pretreated for 6 hrs followed by H2O2 challenge for 24 hrs by propidium iodide staining based flow cytometry analysis (Rvb= 1.88%)2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1864000Protective index, ratio of TD50 for toxicity in CD-1 seizure mouse model assessed as effect on motor coordination administered ip measured after 0.5 hrs for 3 mins by rotarod test to ED50 for antiseizure activity against electrical stimulus induced seizur
AID1303152Neuroprotective activity in rat hippocampal neurons assessed as protection against ethanol induced cell death after 5 hrs by propidium iodide staining based fluorimetric analysis2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID260281Ability to suppress the production of reactive oxygen intermediates by activated RAW 264.7 macrophages from BALB/c mice at 8 ug/ml2006Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3
New cannabidiol derivatives: synthesis, binding to cannabinoid receptor, and evaluation of their antiinflammatory activity.
AID1692715Elimination rate constant in human using oromucosal-spray measured for 6 weeks2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692700Volume of distribution in human at 20 mg, iv measured after 0.05 to 72 hrs by gas chromatograph mass spectrometry2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1780732Inhibition of IL-1beta expression in H2O2- stimulated human HaCaT cells at 10 uM incubated for 6 hrs followed by H2O2 stimulation measured after 24 hrs by ELISA relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1773260Inhibition of equine serum BuChE using butyrylthiocholine iodide as substrate preincubated with enzyme for 20 mins followed by substrate addition and measured after 20 mins by Ellman's method2021European journal of medicinal chemistry, Nov-05, Volume: 223Novel cannabidiol-carbamate hybrids as selective BuChE inhibitors: Docking-based fragment reassembly for the development of potential therapeutic agents against Alzheimer's disease.
AID1692678Inhibition of sigma2 receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847139Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1782666Non-competitive inhibition of human LDHA assessed as reduction in lactate production using pyruvate as substrate in presence of NADH by Lineweaver-Burk plot analysis2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabichromene and Δ
AID1692681Inhibition of 5-HT2C (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692677Inhibition of alpha2B receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID482747Induction of bone formation in GPR55 knockout male mouse assessed as increase in femur mass volume2010Journal of medicinal chemistry, Jun-10, Volume: 53, Issue:11
Emerging targets in osteoporosis disease modification.
AID1193124Antiinflammatory activity in human glial cells assessed as reduction of LPS-induced S100B expression at 1 uM2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1692704Elimination half-life in human at 20 mg using aerosol spray measured for 6 weeks2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1303155Toxicity in rat hippocampal neurons assessed as neuronal viability after 5 hrs by carboxyfluorescein diacetate dye based fluorimetric analysis2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1692680Inhibition of delta-type opioid receptor receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1193116Reduction of sphingomyelin content in human fibroblast at 30 uM2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1780725Antioxidant activity in human HaCaT cells assessed as reduction in mean fluorescence intensity at 10 uM preincubated for 6 hrs followed by H2O2 stimulation at 600 uM measured after 24 hrs by cellROS staining based flow cytometry analysis2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID132309The difference between the preinjection and postinjection (60 min) temperatures in mice was evaluated at a dose 50 mg/kg1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Hashish: synthesis and central nervous system activity of some novel analogues of cannabidiol and oxepin derivatives of delta 9-tetrahydrocannabinol.
AID1863983Antiseizure activity against ScPTZ-induced seizure in ip dosed CD-1 mouse model assessed as clonic seizures pretreated for 1 hr and measured after 30 mins by subcutaneous pentylenetetrazole test
AID1773253Cytotoxicity against human HepG2 cells assessed as cell viability at 25 uM incubated for 24 hrs by MTT assay2021European journal of medicinal chemistry, Nov-05, Volume: 223Novel cannabidiol-carbamate hybrids as selective BuChE inhibitors: Docking-based fragment reassembly for the development of potential therapeutic agents against Alzheimer's disease.
AID1692699Bioavailability in dog at 180 mg2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1773266Neuroprotective activity against H2O2-induced cytotoxicity in rat PC-12 cells assessed as cell viability at 25 uM pretreated for 3 hrs followed by H2O2 stimulation and measured after 24 hrs by MTT assay (Rvb = 38.7%)2021European journal of medicinal chemistry, Nov-05, Volume: 223Novel cannabidiol-carbamate hybrids as selective BuChE inhibitors: Docking-based fragment reassembly for the development of potential therapeutic agents against Alzheimer's disease.
AID1692641Inhibition of sigma 1 receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1303158Displacement of [3H]WIN 55212-2 from human recombinant CB2 receptor expressed in CHO cell membranes at 10 uM after 120 mins by scintillation counting analysis2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1453018Competitive inhibition of human liver microsomes CYP1A1 expressed in supersomes coexpressing NADPH-CYP reductase using 7-Ethoxyresorufin as substrate measured every 5 mins for 30 mins in presence of NADPH by fluorescence assay2017European journal of medicinal chemistry, Jul-28, Volume: 135Inhibitors of cytochrome P450 (CYP) 1B1.
AID1692640Inhibition of M3 receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692718Non-competitive inhibition of human recombinant CYP2A6 expressed in baculovirus-infected insect cells using coumarin as substrate preincubated for 5 mins followed by NADPH-generating system addition by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1625151Inhibition of recombinant human DAGLalpha expressed in COS7 cells at 50 uM using [14C]-oleoyl-2-arachidonoyl-glycerol as substrate measured after 20 mins by beta-counting method relative to control2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1692646Inhibition of 5-HT3 receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1193121Antiinflammatory activity in Swiss OF1 mouse assessed as reduction of LPS-induced TNF-alpha expression at 10 mg/kg, ip by immunoblotting analysis2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1773263n-Octanol/PBS partition coefficient, logP of the compound incubated for 48 hrs at pH 7.4 by shake flask method2021European journal of medicinal chemistry, Nov-05, Volume: 223Novel cannabidiol-carbamate hybrids as selective BuChE inhibitors: Docking-based fragment reassembly for the development of potential therapeutic agents against Alzheimer's disease.
AID1692724Competitive inhibition of human recombinant CYP3A4 expressed in baculovirus-infected insect cells using diltiazem as substrate incubated for 15 mins followed by NADPH-generating system addition by Michaelis-Menten plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1780719Effect on cell cycle distribution in human HaCaT cells assessed as >4N cells at 10 uMpretreated for 6 hrs followed by H2O2 challenge for 24 hrs by propidium iodide staining based flow cytometry analysis (Rvb= 11.1%)2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1524913Cytotoxicity against human HepG2 cells assessed as reduction in cell viability incubated for 24 to 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1830990Antiplasmodial activity against chloroquine-sensitive Plasmodium falciparum NF542021Bioorganic & medicinal chemistry letters, 12-15, Volume: 54THC shows activity against cultured Plasmodium falciparum.
AID1590134Reduction in anandamide production in athymic CD-1 nude mouse xenografted with human U87 cells at 0.5 mg/mouse/day administered peritumorally for 5 days by RP-HPLC with fluorimetric detection method relative to control2019Bioorganic & medicinal chemistry, 07-01, Volume: 27, Issue:13
Eicosanoid mediation of cannabinoid actions.
AID1847114Partial agonist activity at CBR2 V361.35M mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HTRF2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1847161Partial agonist activity at CBR2 S2857.39L mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692702Maximum drug concentration in Swiss mouse brain at 120 mg/kg, po measured up to 24 hrs by HPLC analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847140Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins by AlphaScreenSureFire method relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1863992Protective index, ratio of TD50 for toxicity in CD-1 seizure mouse model assessed as effect on motor coordination administered ip measured after 0.5 hrs for 3 mins by rotarod test to ED50 for antiseizure activity against electrical stimulus induced seizur
AID1847155Partial agonist activity at CBR2 A2827.36M mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1524902Cytotoxicity against human OVCAR cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1193119Reduction of NO release in C57BL/6J mouse hippocampus inoculated with human amyloid beta (1 to 42) at 10 ug/kg, ip after 7 days2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1660166Modulation of intracellular calcium release in LPS-stimulated human THP1 cells at 1 to 100 uM incubated for 1 hr followed by nigericin challenge and measured after 1 hr by Fluo-3dye based flow cytometric analysis2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1830991Antiplasmodial activity against multidrug-resistant Plasmodium falciparum K12021Bioorganic & medicinal chemistry letters, 12-15, Volume: 54THC shows activity against cultured Plasmodium falciparum.
AID1692723Inhibition of CYP2D6 in human liver microsomes using dextromethorphan as substrate incubated for 10 mins in presence of NADPH generating by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1303160Apparent permeability from apical to basolateral side in human Caco cells2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1847151Partial agonist activity at CBR2 A2827.36M mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1625161Inhibition of recombinant human NAAA expressed in HEK293 cells at 50 uM using [14C]-N-palmitoylethanolamine as substrate measured after 30 mins by beta-counting method relative to control2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1847100Partial agonist activity at wild type CB2 receptor (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins by HTRF assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1193114Reduction of sphingomyelin content in Niemann-Pick patient fibroblast at 30 uM2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1692687Inhibition of sigma2 receptor (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847186Partial agonist activity at CBR2 A2827.36M mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1660160Inhibition of TNF-alpha secretion in LPS-stimulated human THP1 cells assessed as TNF-alpha level at 10 uM incubated for 1 hr followed by nigericin addition and measured after 1 hr by ELISA (Rvb = 957.6 pg/mL)2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1649367Toxicity in CF1 mouse assessed as induction of motor impairment during acute (1 hr) observation period by rotarod assay
AID1524903Cytotoxicity against human A549 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1847121Partial agonist activity at CBR2 A2827.36M mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HTR2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1863980Anti-seizure activity against electrical stimulus induced seizure in ip dosed CD-1 mouse model assessed as normal behavior within 10 seconds after stimulation at 6 Hz and 32 mA for 3 secs pretreated for 1 hr by psychomotor seizure test
AID1692686Inhibition of alpha2B receptor (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847108Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HTR2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1847189Partial agonist activity at CBR2 S2857.39L mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1780738Binding affinity to recombinant human caspase-1 assessed as dissociation constant at equilibrium measured after 30 sec by SPR method2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1847192Partial agonist activity at CBR2 S2857.39L mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1762667Antiinflammatory activity in mouse BV-2 cells assessed as reduction in LPS-induced nitric oxide production incubated for 24 hrs by 2, 3-diaminonaphthalene based assay2021Bioorganic & medicinal chemistry, 06-01, Volume: 39Cannabidiol-dihydroartemisinin conjugates for ameliorating neuroinflammation with reduced cytotoxicity.
AID1590133Reduction in LTB4 production in athymic CD-1 nude mouse xenografted with human U87 cells at 0.5 mg/mouse/day administered peritumorally for 5 days by RP-HPLC analysis relative to control2019Bioorganic & medicinal chemistry, 07-01, Volume: 27, Issue:13
Eicosanoid mediation of cannabinoid actions.
AID260286Ability to suppress TNFalpha production by LPS-activated peritoneal macrophages form C57BL/6 mice at 8 ug/ml2006Journal of medicinal chemistry, Feb-09, Volume: 49, Issue:3
New cannabidiol derivatives: synthesis, binding to cannabinoid receptor, and evaluation of their antiinflammatory activity.
AID1692665Inhibition of 5-HT1A (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID132306The difference between the preinjection and postinjection (60 min) temperatures in mice was evaluated at a dose 40 mg/kg1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Hashish: synthesis and central nervous system activity of some novel analogues of cannabidiol and oxepin derivatives of delta 9-tetrahydrocannabinol.
AID1847549Metabolic stability in human liver microsomes assessed as half life2021European journal of medicinal chemistry, Dec-15, Volume: 226Carbon-silicon switch led to the discovery of novel synthetic cannabinoids with therapeutic effects in a mouse model of multiple sclerosis.
AID1681225Antagonist activity at rat TRPV2 expressed in HEK293 cells assessed as inhibition of LPC-induced Ca2+ response preincubated for 5 mins followed by LPC addition by Fluo-4AM dye based fluorescence assay2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1847124Partial agonist activity at CBR2 A2827.36M mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HTR2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1127483Binding affinity to human CB2 receptor2013Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21
Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
AID1692642Inhibition of alpha2A receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692650Inhibition of NET receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1660152Antiinflammatory activity in LPS-induced human THP1 cells assessed as IL-1beta secretion at 0.1 uM incubated for 1 hr followed by LPS stimulation and measured after 24 hrs by ELISA (Rvb = 51.2 pg/mL)2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1692656Inhibition of GABAA receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692692Tmax in human plasma at 14+/- 15 mg, po2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1681220Agonist activity at rat TRPV4 stably transfected in HEK293 cells assessed as increase in calcium influx in presence of ionomycin by Fluo-4-AM dye based spectrofluorimetric method2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1681218Agonist activity at rat TRPA1 stably transfected in HEK293 cells assessed as increase in calcium influx by Fluo-4-AM dye based spectrofluorimetric method relative to allylisothiocyanate2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1692725Competitive inhibition of human recombinant CYP3A5 expressed in baculovirus-infected insect cells using diltiazem as substrate incubated for 15 mins followed by NADPH-generating system addition by Michaelis-Menten plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847193Negative allosteric modulation of JWH-133-induced agonist activity at wild type CB2 receptor (unknown origin) stably expressed in HEK293T cells assessed as decrease in cAMP levels preincubated for 15 mins followed by forskolin addition incubated for 15 mi2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1303153Neuroprotective activity in rat hippocampal neurons assessed as protection against ammonium acetate induced cell death by measuring neuronal viability after 5 hrs by carboxyfluorescein diacetate dye based fluorimetric analysis2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1660157Inhibition of NLRP3 inflammasome activation in LPS-stimulated human THP1 cells assessed as reduction in IL-1beta secretion at 1 uM incubated for 1 hr followed by nigericin addition and measured after 1 hr by ELISA relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1692721Competitive inhibition of CYP2C11 in rat liver microsomes2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847551Metabolic stability in mouse liver microsomes assessed as half life2021European journal of medicinal chemistry, Dec-15, Volume: 226Carbon-silicon switch led to the discovery of novel synthetic cannabinoids with therapeutic effects in a mouse model of multiple sclerosis.
AID1780728Antioxidant activity in human HaCaT cells assessed as reduction in mitochondria-derived ROS production by measuring mean fluorescence intensity at 10 uM preincubated for 6 hrs followed by H2O2 stimulation at 600 uM measured after 24 hrs by mitoSOX stainin2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1847552Metabolic stability in human liver microsomes assessed as intrinsic clearance2021European journal of medicinal chemistry, Dec-15, Volume: 226Carbon-silicon switch led to the discovery of novel synthetic cannabinoids with therapeutic effects in a mouse model of multiple sclerosis.
AID1692643Inhibition of D5 dopamine receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1660164Modulation of P2X7 receptor in LPS-stimulated human THP1 cells assessed as LPS-nigericin-stimulated intracellular potassium efflux at 1 uM incubated for 1 hr followed by nigericin challenge and measured after 1 hr by Green-2 AM dye based flow cytometric a2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1780723Antioxidant activity in human HaCaT cells assessed as reduction in mean fluorescence intensity at 10 uM preincubated for 6 hrs followed by H2O2 stimulation at 200 uM measured after 24 hrs by cellROS staining based flow cytometry analysis2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1867003Activation of Nrf2 transcriptional activity in human HaCaT-ARE-Luc cells at 1 to 25 uM incubated for 6 hrs by luciferase activity assay
AID1692683Inhibition of kappa-type opioid receptor (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1773262Inhibition of electric eel AChE using acetylthiocholine iodide as substrate preincubated with enzyme for 20 mins followed by substrate addition and measured after 20 mins by Ellman's method2021European journal of medicinal chemistry, Nov-05, Volume: 223Novel cannabidiol-carbamate hybrids as selective BuChE inhibitors: Docking-based fragment reassembly for the development of potential therapeutic agents against Alzheimer's disease.
AID1692655Inhibition of muscarinic acetylcholine receptor M5 (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1127482Binding affinity to human CB1 receptor2013Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21
Therapeutic utility of cannabinoid receptor type 2 (CB(2)) selective agonists.
AID1847142Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins in presence of JWH-133 by AlphaScreenSureFire method relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692720Competitive inhibition of CYP2C9 in pooled human liver microsomes using S-warfarin as substrate preincubated for 5 mins followed by NADPH-generating system addition and measured after 20 mins by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1524910Cytotoxicity against human A549 cells assessed as reduction in cell viability incubated for 24 to 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1692649Inhibition of beta-3 adrenergic receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1780716Effect on cell cycle distribution in human HaCaT cells assessed as 2N cells at 10 uM pretreated for 6 hrs followed by H2O2 challenge for 24 hrs by propidium iodide staining based flow cytometry analysis (Rvb= 17.9%)2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692688Inhibition of alpha2C receptor (unknown origin)2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID624672Mechanism based inhibition of mouse cytochrome P450 CYP3A112005Current drug metabolism, Oct, Volume: 6, Issue:5
Cytochrome p450 enzymes mechanism based inhibitors: common sub-structures and reactivity.
AID1692732Drug degradation in simulated gastric fluid at 40 mg assessed as formation of d9-tetrahydrocannabinol incubated for 2 hrs by UPLC-MS analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1780724Antioxidant activity in human HaCaT cells assessed as reduction in mean fluorescence intensity at 10 uM preincubated for 6 hrs followed by H2O2 stimulation at 400 uM measured after 24 hrs by cellROS staining based flow cytometry analysis2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1193127Inhibition of human neutrophil migration incubated for 30 mins prior to fMLP challenge by boyden chamber assay2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1303163Efflux ratio of permeability from basolateral to apical over apical to basolateral side in MDCK cells expressing MDR12016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1193115Reduction of lecithin content in human fibroblast at 30 uM2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1626211Binding affinity to human serum albumin at 40 uM by surface plasmon resonance method2016Journal of medicinal chemistry, 07-28, Volume: 59, Issue:14
Chromenopyrazole, a Versatile Cannabinoid Scaffold with in Vivo Activity in a Model of Multiple Sclerosis.
AID1847180Partial agonist activity at CBR2 V361.35M mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692696Tmax in human plasma at 3.5 +/- 5.5 mg, INH2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1303159Kinetic aqueous solubility of the compound at pH 7.42016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1303164Displacement of [3H]-HU-243 from CB1 receptor in Sabra rat brain synaptosomes after 90 mins2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1692703Cmax in mouse brain at 10 mg/kg, sc measured after 1 to 3 hrs by HPLC analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847164Partial agonist activity at wild type CB2 receptor (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1773259Antioxidant activity assessed as DPPH radical scavenging activity at 100 uM incubated for 2 hrs by microplate reader method2021European journal of medicinal chemistry, Nov-05, Volume: 223Novel cannabidiol-carbamate hybrids as selective BuChE inhibitors: Docking-based fragment reassembly for the development of potential therapeutic agents against Alzheimer's disease.
AID1847134Partial agonist activity at wild type CB2 receptor (unknown origin) expressed in HEK293T assessed as increase in ERK1/2 phosphorylation incubated for 7 mins by AlphaScreenSureFire method relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID1692698Bioavailability in human at 3.5 +/- 5.5 mg, INH measured after 0.05 to 72 hrs by gas chromatograph mass spectrometry2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1660147Cytotoxicity against human THP1 cells assessed as cell viability at 0.1 uM after 24 hrs by CellTiter-Glo luminescent cell viability assay relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1780721Cytoprotective activity against H2O2-induced oxidative stress in human HaCaT cells assessed as change in cellular ROS level at 1 uM incubated for 6 hrs followed by H2O2 stimulation measured after 24 hrs by DCF-DA dye based fluorescence analysis (Rvb = 8.22021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692666Inhibition of 5-HT5A (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847111Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) stably expressed in HEK293T assessed as decrease in forskolin induced cAMP level preincubated for 15 mins followed by forskolin addition incubated for 15 mins in presence of JWH-133 by HTR2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID362545Antibacterial activity against epidemic methicillin-resistant Staphylococcus aureus 15 after 18 hrs2008Journal of natural products, Aug, Volume: 71, Issue:8
Antibacterial cannabinoids from Cannabis sativa: a structure-activity study.
AID1692652Inhibition of 5-HT6 (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1660163Modulation of P2X7 receptor in nigericin-stimulated human THP1 cells assessed as intracellular potassium efflux at 10 uM incubated for 30 mins followed by 10 uM nigericin challenge and measured after 30 mins by Green-2 AM dye based flow cytometric analysi2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1660153Antiinflammatory activity in LPS-induced human THP1 cells assessed as IL-1beta secretion at 1 uM incubated for 1 hr followed by LPS stimulation and measured after 24 hrs by ELISA (Rvb = 51.2 pg/mL)2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1692670Inhibition of SERT (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1625153Inhibition of MAGL in African green monkey COS cell homogenates using [3H]-arachidonoylglycerol as substrate measured after 20 mins by scintillation counting method2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1692644Inhibition of 5-HT1E receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1780718Effect on cell cycle distribution in human HaCaT cells assessed as 4N cells at 10 uM pretreated for 6 hrs followed by H2O2 challenge for 24 hrs by propidium iodide staining based flow cytometry analysis (Rvb= 41.0%)2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1626212Binding affinity to PDEA modified AGP (unknown origin) at 40 uM by surface plasmon resonance method2016Journal of medicinal chemistry, 07-28, Volume: 59, Issue:14
Chromenopyrazole, a Versatile Cannabinoid Scaffold with in Vivo Activity in a Model of Multiple Sclerosis.
AID1660165Modulation of P2X7 receptor in LPS-stimulated human THP1 cells assessed as LPS-nigericin-stimulated intracellular potassium efflux at 10 uM incubated for 1 hr followed by nigericin challenge and measured after 1 hr by Green-2 AM dye based flow cytometric 2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1625159Inhibition of recombinant human NAAA expressed in HEK293 cells using [14C]-N-palmitoylethanolamine as substrate measured after 30 mins by beta-counting method2019Journal of natural products, 03-22, Volume: 82, Issue:3
Plant-Based Modulators of Endocannabinoid Signaling.
AID1681223Agonist activity at rat TRPV3 stably transfected in HEK293 cells assessed as increase in calcium influx in presence of ionomycin by Fluo-4-AM dye based spectrofluorimetric method2020Journal of natural products, 09-25, Volume: 83, Issue:9
Cannabitwinol, a Dimeric Phytocannabinoid from Hemp,
AID1660151Cytotoxicity against human THP1 cells assessed as cell viability at 0.1 to 100 uM after 24 hrs in presence of LPS by CellTiter-Glo luminescent cell viability assay relative to control2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1780726Antioxidant activity in human HaCaT cells assessed as reduction in mitochondria-derived ROS production by measuring mean fluorescence intensity at 10 uM preincubated for 6 hrs followed by H2O2 stimulation at 200 uM measured after 24 hrs by mitoSOX stainin2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1692730Drug conversion in artificial gastric juice assessed as formation of d9-tetrahydrocannabinol at 250 ug incubated for 20 hrs by GC-MS analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1847174Partial agonist activity at CBR2 V1133.32M mutant (unknown origin) expressed in HEK293T assessed as increase in picometer shifts of reflected light wavelengths in presence of JWH-133 by DMR assay relative to control2021Journal of medicinal chemistry, 07-08, Volume: 64, Issue:13
Design of Negative and Positive Allosteric Modulators of the Cannabinoid CB
AID482754Antiosteoporotic activity in mouse assessed as increase in bone volume at 10 mg/kg administered 3 times a week for 8 weeks2010Journal of medicinal chemistry, Jun-10, Volume: 53, Issue:11
Emerging targets in osteoporosis disease modification.
AID1780714Cytoprotective activity against H2O2-induced oxidative stress in human HaCaT cells assessed as increase in cell viability at 10 uM incubated for 24 hrs followed by H2O2 stimulation by celltiter-glo assay relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1847550Metabolic stability in rat liver microsomes assessed as half life2021European journal of medicinal chemistry, Dec-15, Volume: 226Carbon-silicon switch led to the discovery of novel synthetic cannabinoids with therapeutic effects in a mouse model of multiple sclerosis.
AID1692708Competitive inhibition of human recombinant CYP1A2 using 7-Ethoxyresorufin as substrate by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID49851Binding affinity towards cloned human cannabinoid receptor 22000Journal of medicinal chemistry, Jun-15, Volume: 43, Issue:12
A 3D-QSAR study on the structural requirements for binding to CB(1) and CB(2) cannabinoid receptors.
AID1303154Neuroprotective activity in rat hippocampal neurons assessed as protection against ammonium acetate induced cell death after 5 hrs by propidium iodide staining based fluorimetric analysis2016ACS medicinal chemistry letters, Apr-14, Volume: 7, Issue:4
Discovery of KLS-13019, a Cannabidiol-Derived Neuroprotective Agent, with Improved Potency, Safety, and Permeability.
AID1524906Cytotoxicity against human HepG2 cells assessed as reduction in cell viability incubated for 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1692645Inhibition of beta1 adrenergic receptor (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1692711Half-life in human at 20 mg via smoking measured after 0.05 to 72 hrs by gas chromatograph mass spectrometry2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1660162Modulation of P2X7 receptor in nigericin-stimulated human THP1 cells assessed as intracellular potassium efflux at 10 uM incubated for 30 mins followed by 5 uM nigericin challenge and measured after 30 mins by Green-2 AM dye based flow cytometric analysis2020Journal of natural products, 06-26, Volume: 83, Issue:6
Inhibitory Effect of Cannabidiol on the Activation of NLRP3 Inflammasome Is Associated with Its Modulation of the P2X7 Receptor in Human Monocytes.
AID1780729Downregulation of caspase-1 mRNA expression in H2O2- stimulated human HaCaT cells at 10 uM incubated for 6 hrs by SPE based fluorescence amplification assay relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1524915Inhibition of Wnt/beta-catenin signaling pathway in human HepG2 cells assessed as reduction in TCF-dependent beta-catenin mediated transcription incubated for 24 hrs by Topflash reporter assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1692667Inhibition of muscarinic acetylcholine receptor M1 (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1780720Effect on cell cycle distribution in human HaCaT cells assessed as accumulation of cells in G2-M phase at 10 uM pretreated for 6 hrs followed by H2O2 challenge for 24 hrs by propidium iodide staining based flow cytometry analysis relative to control2021Journal of natural products, 05-28, Volume: 84, Issue:5
Cannabidiol Protects Human Skin Keratinocytes from Hydrogen-Peroxide-Induced Oxidative Stress via Modulation of the Caspase-1-IL-1β Axis.
AID1193118Reduction of IL-1beta protein expression in C57BL/6J mouse hippocampus inoculated with human amyloid beta (1 to 42) at 10 ug/kg, ip after 10 days by immunofluorescence analysis2015Bioorganic & medicinal chemistry, Apr-01, Volume: 23, Issue:7
Cannabidiol (CBD) and its analogs: a review of their effects on inflammation.
AID1617308Anticonvulsant activity against hyperthermia-induced seizure in ip administered Scn1aRX/+ mouse model of Dravet syndrome assessed as effective dose causing increase in generalized tonic-clonic seizure temperature threshold measured by RET-3 rectal probe2019Journal of natural products, 11-22, Volume: 82, Issue:11
Pharmacokinetics of Phytocannabinoid Acids and Anticonvulsant Effect of Cannabidiolic Acid in a Mouse Model of Dravet Syndrome.
AID133446Compound was evaluated for the maximum possible effect in tail-flick test in mice at dose 40 mg/kg1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Hashish: synthesis and central nervous system activity of some novel analogues of cannabidiol and oxepin derivatives of delta 9-tetrahydrocannabinol.
AID1847554Metabolic stability in mouse liver microsomes assessed as intrinsic clearance2021European journal of medicinal chemistry, Dec-15, Volume: 226Carbon-silicon switch led to the discovery of novel synthetic cannabinoids with therapeutic effects in a mouse model of multiple sclerosis.
AID1692638Inhibition of muscarinic acetylcholine receptor M4 (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1252763Cytotoxicity against cdkn2a-deficient mouse neurosphere glioma cells at 10 uM after 24 hrs2015European journal of medicinal chemistry, Oct-20, Volume: 103Wittig derivatization of sesquiterpenoid polygodial leads to cytostatic agents with activity against drug resistant cancer cells and capable of pyrrolylation of primary amines.
AID1524909Cytotoxicity against human OVCAR cells assessed as reduction in cell viability incubated for 24 to 72 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Analyzing the role of cannabinoids as modulators of Wnt/β-catenin signaling pathway for their use in the management of neuropathic pain.
AID1692648Inhibition of 5-HT1D (unknown origin) at 10 uM relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
The Essential Medicinal Chemistry of Cannabidiol (CBD).
AID1346701Human CB1 receptor (Cannabinoid receptors)2015British journal of pharmacology, Oct, Volume: 172, Issue:20
Cannabidiol is a negative allosteric modulator of the cannabinoid CB1 receptor.
AID1345070Human GPR55 (GPR18, GPR55 and GPR119)2010Pharmacological reviews, Dec, Volume: 62, Issue:4
International Union of Basic and Clinical Pharmacology. LXXIX. Cannabinoid receptors and their ligands: beyond CB₁ and CB₂.
AID1345070Human GPR55 (GPR18, GPR55 and GPR119)2007British journal of pharmacology, Dec, Volume: 152, Issue:7
The orphan receptor GPR55 is a novel cannabinoid receptor.
AID1346561Human TRPV2 (Transient Receptor Potential channels)2008The Journal of neuroscience : the official journal of the Society for Neuroscience, Jun-11, Volume: 28, Issue:24
TRPV2 is activated by cannabidiol and mediates CGRP release in cultured rat dorsal root ganglion neurons.
AID1346564Rat TRPV2 (Transient Receptor Potential channels)2008The Journal of neuroscience : the official journal of the Society for Neuroscience, Jun-11, Volume: 28, Issue:24
TRPV2 is activated by cannabidiol and mediates CGRP release in cultured rat dorsal root ganglion neurons.
AID1346814Human GPR18 (GPR18, GPR55 and GPR119)2012British journal of pharmacology, Apr, Volume: 165, Issue:8
Δ(9) -Tetrahydrocannabinol and N-arachidonyl glycine are full agonists at GPR18 receptors and induce migration in human endometrial HEC-1B cells.
AID1347414qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Secondary screen by immunofluorescence2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347412qHTS assay to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Counter screen cell viability and HiBit confirmation2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1802031FABP1 Fluorescent Ligand Displacement Assay from Article 10.1021/acs.biochem.6b00446: \\FABP1: A Novel Hepatic Endocannabinoid and Cannabinoid Binding Protein.\\2016Biochemistry, 09-20, Volume: 55, Issue:37
FABP1: A Novel Hepatic Endocannabinoid and Cannabinoid Binding Protein.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (3,178)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990205 (6.45)18.7374
1990's62 (1.95)18.2507
2000's203 (6.39)29.6817
2010's1091 (34.33)24.3611
2020's1617 (50.88)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials321 (9.79%)5.53%
Reviews624 (19.03%)6.00%
Case Studies73 (2.23%)4.05%
Observational40 (1.22%)0.25%
Other2,221 (67.73%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (260)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5). [NCT05269459]Phase 2180 participants (Anticipated)Interventional2022-12-01Recruiting
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of CBD TPM Capsules in Adults for Use in the Reduction of Insomnia Severity [NCT05840822]Phase 3540 participants (Anticipated)Interventional2023-06-30Not yet recruiting
Effects of Cannabidiol in Alcohol Use Disorder [NCT03252756]Phase 1/Phase 227 participants (Actual)Interventional2019-09-01Completed
Cannabidiol as Treatment Intervention for Opioid Relapse [NCT01311778]Phase 118 participants (Actual)Interventional2010-02-28Completed
Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial [NCT05822362]Phase 2236 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Tolerability and Efficacy of Hemp-Derived CBD for the Treatment of Alcohol Use Disorder [NCT04873453]Phase 245 participants (Actual)Interventional2021-08-30Completed
Randomized Placebo-controlled Trial to Determine the Biological Signature of Cannabidiol as a Treatment for Social Anxiety Disorder (R61) [NCT05571592]Phase 260 participants (Anticipated)Interventional2023-01-26Recruiting
Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD) [NCT02759185]Phase 280 participants (Actual)Interventional2017-01-02Completed
An Open-label Extension Trial to Investigate the Long-term Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome [NCT04252586]Phase 321 participants (Actual)Interventional2020-02-28Terminated(stopped due to Study was terminated due to COVID-19 pandemic and recruitment challenges in the parent study (GWND18064 - NCT03848832).)
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients [NCT04056442]Phase 228 participants (Anticipated)Interventional2019-07-07Recruiting
A Randomized Placebo-controlled Trial of Cannabidiol to Treat Severe Behavioral Problems in Children and Adolescents With Intellectual Disability [NCT04821856]Phase 2140 participants (Anticipated)Interventional2021-05-11Recruiting
A Pilot Human Laboratory Study of Cannabidiol in Alcohol Use Disorder [NCT03904849]Phase 1/Phase 20 participants (Actual)Interventional2019-10-01Withdrawn(stopped due to This study was intended to produce pilot data for a center grant component that will no longer be conducted.)
Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder [NCT03102918]Phase 110 participants (Actual)Interventional2016-02-20Completed
University of Alabama at Birmingham (UAB) Adult CBD Program [NCT02700412]Phase 180 participants (Actual)Interventional2015-04-30Completed
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease [NCT02392780]Phase 210 participants (Anticipated)Interventional2015-04-30Not yet recruiting
The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol [NCT03164512]Phase 119 participants (Actual)Interventional2018-06-01Completed
Mechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain Phenotype [NCT05269628]Phase 2166 participants (Anticipated)Interventional2022-03-25Recruiting
Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans [NCT01180374]Early Phase 127 participants (Actual)Interventional2010-02-01Completed
The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children [NCT02815540]Phase 1/Phase 22 participants (Actual)Interventional2017-02-16Terminated(stopped due to Investigator no longer at institution, and difficult recruitment; study will not resume)
The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking [NCT02112292]10 participants (Actual)Interventional2014-04-30Completed
Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV [NCT05514899]Phase 2100 participants (Anticipated)Interventional2023-07-15Recruiting
Cannabidiol Effects on Learning and Anxiety [NCT05283382]Early Phase 1160 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study [NCT02083874]Phase 25 participants (Anticipated)Interventional2014-03-31Active, not recruiting
Phase I, Single Center, Open-label Study of Cannabidiol in Patients With Heart Failure in AHA/ACC Stages A-C [NCT03634189]Phase 120 participants (Anticipated)Interventional2021-03-01Not yet recruiting
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery [NCT05240755]Early Phase 150 participants (Anticipated)Interventional2022-07-01Recruiting
Impact of Cannabidiol-Rich Hemp Extract Oil on Reconsolidation Disruption of Naturalistic Interoceptive Aversive Memory in Humans [NCT04726475]Phase 1/Phase 296 participants (Anticipated)Interventional2022-01-31Recruiting
Shifting Brain Excitation-Inhibition Balance Through the Endocannabinoid System in Men With Autism Spectrum Disorder (ASD) and in Healthy Controls [NCT03537950]38 participants (Actual)Interventional2016-08-22Active, not recruiting
Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis [NCT03883360]Phase 20 participants (Actual)Interventional2050-01-31Withdrawn(stopped due to not funded)
Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Placebo-Controlled Pilot Trial [NCT05388058]Phase 230 participants (Actual)Interventional2022-06-09Active, not recruiting
PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product [NCT03984565]Phase 256 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Cannabidiol as an Adjunctive to Prolonged Exposure for the Treatment of PTSD [NCT03518801]Phase 2136 participants (Anticipated)Interventional2019-03-01Recruiting
Physician Expanded Access to Investigational New Drug Cannabidiol for the Treatment of Drug Resistant Epilepsy [NCT02461706]0 participants Expanded AccessNo longer available
A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of [NCT03196934]0 participants Expanded AccessAvailable
CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study [NCT03693833]Phase 2136 participants (Actual)Interventional2018-11-28Completed
Interaction Between Cannabidiol, Meal Ingestion, and Liver Function [NCT04971837]26 participants (Actual)Interventional2021-05-20Completed
Randomized Double-Blind, Placebo-Controlled Parallel Multi-Center Study to Assess the Efficacy of Cannabidiol (BRCX014) Combined With Standard-Of-Care Treatment in Subjects With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies [NCT03607643]Phase 1/Phase 2160 participants (Anticipated)Interventional2019-01-15Not yet recruiting
Observational, Prospective, Multicenter Study of Epidyolex® (Cannabidiol CBD 100 mg/ml) Oral Solution, as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) [NCT05485831]70 participants (Anticipated)Observational2024-03-01Not yet recruiting
A Four-week, Multicentre, Double-blinded, Randomised, Active- and Placebo- Controlled, Parallel-group Trial Investigating Efficacy and Safety of Cannabidiol in Acute, Early-stage Schizophrenic Patients [NCT02088060]Phase 2150 participants (Anticipated)Interventional2014-03-31Active, not recruiting
Cannabidiol for the Treatment of Pediatric Epilepsy (Expanded Access/Compassionate Use Protocol) [NCT02556008]0 participants Expanded AccessNo longer available
A 2-part Study to Investigate the Dose-ranging Pharmacokinetics and Tolerability, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With [NCT02286986]Phase 126 participants (Actual)Interventional2014-09-18Completed
An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes. [NCT02224573]Phase 3681 participants (Actual)Interventional2015-06-11Completed
[NCT02255292]Phase 260 participants (Anticipated)Interventional2014-11-30Not yet recruiting
Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies [NCT05613608]Phase 2/Phase 3180 participants (Anticipated)Interventional2023-04-30Recruiting
A Phase 2, Open-label, Dose-finding Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures [NCT03336242]Phase 220 participants (Actual)Interventional2017-12-29Terminated(stopped due to More patients in Cohort 1 than Cohort 2 demonstrated a clinically meaningful reduction of seizure count. Given this, enrollment of Cohort 3 was discontinued.)
Effects of Cannabidiol (CBD) Oral Solution in Patients Undergoing Bilateral Total Knee Arthroplasty: a Randomized, Controlled, Parallel, Triple Blind, Pilot Study [NCT04749628]Phase 436 participants (Anticipated)Interventional2022-11-02Recruiting
A Randomized Placebo-Controlled Evaluation of the Safety of Oral Cannabidiol in a Clinically Relevant Model of Opioid Withdrawal [NCT04238754]Phase 1/Phase 23 participants (Actual)Interventional2020-11-01Completed
Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis [NCT04911127]Phase 1/Phase 260 participants (Anticipated)Interventional2021-10-05Recruiting
A Double-blind, Randomized Placebo-controlled Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epileptic Crisis in Children and Adolescents [NCT02783092]Phase 3126 participants (Anticipated)Interventional2019-01-09Active, not recruiting
Enhancing Recovery in Early Schizophrenia - a Multi-center, Two-arm, Double-blind, Randomized Phase II Trial Investigating Cannabidiol vs. Placebo as an add-on to an Individualized Antipsychotic Treatment [NCT02926859]Phase 2180 participants (Anticipated)Interventional2017-04-08Recruiting
Open-label Pilot Study to Assess the Efficacy and Safety of Cannabidiol Oral Solution as an Adjunctive Treatment for Children and Young Adults With Rare Disease-associated Severe Epilepsy [NCT05803434]Phase 230 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Cannabidiol for Reducing Drinking in Alcohol Use Disorder and Modifying the Effects of Alcohol on the Brain and the Liver: a Phase 2 Clinical Trial.-The CARAMEL Study [NCT05159830]Phase 276 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Cannabidiol for the Treatment of Anxiety Disorders: An 8-Week Pilot Study [NCT03549819]Phase 350 participants (Anticipated)Interventional2021-12-15Recruiting
Cannabidiol (CBD) in Patients With Mild to Moderate Symptoms of Coronavirus 2019: A Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT04467918]Phase 2/Phase 3100 participants (Anticipated)Interventional2020-07-06Active, not recruiting
Effects of D-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on Human Episodic Memory Function [NCT02291562]20 participants (Actual)Interventional2014-07-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children, Adolescents and Young Adults With Fragile X Syndrome - RECONNECT [NCT04977986]Phase 3204 participants (Anticipated)Interventional2021-09-13Recruiting
Pilot Trial of Cannabidiol (CBD) for Sleep Problems in People With HIV [NCT05097651]Phase 216 participants (Anticipated)Interventional2023-04-01Recruiting
Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD) [NCT02291536]20 participants (Actual)Interventional2014-02-28Completed
Hemp-derived Cannabidiol for the Treatment of Cannabis Use Disorder: A Double-blind Placebo-controlled Randomized Trial [NCT06107062]Phase 2165 participants (Anticipated)Interventional2024-03-01Not yet recruiting
Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human Subjects [NCT06105138]36 participants (Actual)Interventional2021-03-09Completed
Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study [NCT03467620]Phase 2/Phase 30 participants (Actual)Interventional2018-07-31Withdrawn(stopped due to Inadequate funding)
A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study [NCT02954887]Phase 39 participants (Actual)Interventional2017-05-12Completed
A Single-arm, Open-label Feasibility Pilot of Cannabidiol as an Adjunct to Sublingual Buprenorphine on Cue-induced Cravings Among Individuals With Opioid Use Disorder [NCT04192370]Phase 28 participants (Actual)Interventional2020-08-03Completed
Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System and Brain Function [NCT02492074]Phase 160 participants (Anticipated)Interventional2020-06-30Not yet recruiting
Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation [NCT02478424]Phase 210 participants (Anticipated)Interventional2015-07-31Not yet recruiting
Neuroimaging and CBD for Opiod Use Disorder [NCT04567784]Phase 2160 participants (Anticipated)Interventional2020-11-12Recruiting
Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder [NCT05015439]Phase 140 participants (Anticipated)Interventional2023-04-20Recruiting
Cannabidiol Effects on Chronic Periodontitis: Monocentric, Randomized, Interventional and Placebo-controlled Study [NCT05498012]Phase 1/Phase 290 participants (Actual)Interventional2020-11-05Completed
A Randomized, Controlled Trial of Cannabis in Bipolar Disorder Patients and Healthy Volunteers Evaluating Cognition and Endocannabinoid Levels [NCT04231643]Early Phase 1144 participants (Anticipated)Interventional2021-09-01Recruiting
Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System, Cognition and Neuronal Oscillations [NCT02487381]Phase 160 participants (Anticipated)Interventional2015-04-30Completed
A Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease [NCT02818777]Phase 213 participants (Actual)Interventional2016-10-31Completed
A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression [NCT03310593]Phase 2/Phase 336 participants (Actual)Interventional2017-11-01Terminated(stopped due to It was interrupted due to the coronavirus pandemic outbreak.)
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo [NCT02051387]Phase 174 participants (Actual)Interventional2013-01-31Completed
Modulation of ∆9-tetrahydrocannabinol Acute Psychoactive Effects by Ranging Doses of Cannabidiol in Healthy, Occasional Cannabis Users: a Controlled, Triple Blind, Randomized, Cross-over Study [NCT06099379]Phase 1/Phase 2100 participants (Anticipated)Interventional2023-11-15Not yet recruiting
Do Adolescents and Adults Differ in Their Acute Subjective, Behavioural and Neural Responses to Cannabis, With and Without Cannabidiol? [NCT04851392]48 participants (Actual)Interventional2019-03-11Completed
A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Carpal Tunnel Syndrome [NCT06108349]Phase 220 participants (Anticipated)Interventional2023-11-01Not yet recruiting
An Open-Label Exploratory Investigation of Cognitive Outcomes With Cannabidiol Oral Solution (EPIDIOLEX®; GWP42003-P) [NCT04133480]Phase 40 participants (Actual)Interventional2020-10-31Withdrawn(stopped due to The decision to withdraw the study was based on pandemic-related concerns of conducting a Phase IV study requiring multiple clinic visits when medication is commercially available. The study was withdrawn before any participants were recruited.)
Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder: A Pilot Study [NCT05132699]Phase 1/Phase 222 participants (Actual)Interventional2022-04-04Completed
Sublingual Cannabidiol for Anxiety [NCT02548559]Phase 297 participants (Anticipated)Interventional2018-08-14Recruiting
Sublingual Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting in Elective Gynaecological Patients at the University Hospital of the West Indies (UHWI) [NCT06137027]Early Phase 1120 participants (Anticipated)Interventional2023-09-21Recruiting
Sex Differences in the Interface Between Cannabis Use and Stress Among Emerging Adults [NCT05885542]Phase 1/Phase 2148 participants (Anticipated)Interventional2023-11-01Recruiting
Cannabidiol as a New Treatment for Cocaine Addiction [NCT02559167]Phase 279 participants (Actual)Interventional2016-07-01Completed
Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain [NCT03891264]Phase 47 participants (Actual)Interventional2019-11-13Terminated(stopped due to Funding obtained to do a larger placebo-controlled trial)
A Double-Blind, Crossover Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism [NCT04517799]Phase 2/Phase 342 participants (Actual)Interventional2020-06-01Active, not recruiting
Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers [NCT02751359]Phase 1/Phase 218 participants (Actual)Interventional2016-07-31Completed
Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study [NCT04267679]Phase 20 participants (Actual)Interventional2020-03-01Withdrawn(stopped due to Stopped due to COVID-19 pandemic.)
Cannabidiol (CBD) for the Management of Emergency Dental Pain [NCT04642404]Phase 1/Phase 264 participants (Actual)Interventional2021-03-01Completed
A Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy [NCT02607891]Phase 235 participants (Actual)Interventional2016-11-09Completed
An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Yea [NCT04485104]Phase 327 participants (Anticipated)Interventional2021-05-19Recruiting
Randomized, Double-blind Phase II Study of a Single Dose of Cannabidiol (CBD) for Acute Anticipatory Anxiety in Advanced Breast Cancer [NCT04482244]Phase 250 participants (Anticipated)Interventional2022-01-19Recruiting
Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial [NCT05180240]Phase 2100 participants (Anticipated)Interventional2022-06-22Recruiting
Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee [NCT04992624]Phase 2200 participants (Anticipated)Interventional2022-02-22Recruiting
A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome [NCT03848832]Phase 329 participants (Actual)Interventional2019-07-29Terminated(stopped due to The study was terminated due to enrollment challenges and the COVID-19 pandemic.)
An Open-Label, Randomized, Single-Dose, Two-Sequence, Two-Treatment, Four-Period, Crossover Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience. [NCT02325011]Phase 114 participants (Actual)Interventional2014-11-30Completed
Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients [NCT04271917]Phase 368 participants (Actual)Interventional2020-02-24Completed
Epidiolex® For The Treatment Of Anxiety Comorbidity in Refractory Pediatric Epilepsy [NCT05324449]Phase 420 participants (Anticipated)Interventional2022-04-05Recruiting
The Effects of Topical Cannabidiol Cream on Post-exercise Recovery [NCT05044936]Early Phase 10 participants (Actual)Interventional2023-05-15Withdrawn(stopped due to The researchers were not able to acquire funding to initiate the study. Also, the study was not approved by the local IRB which requested a FDA new drug application.)
The Effect of Medical Cannabidiol on Lean Body Mass in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy [NCT04585841]Phase 132 participants (Actual)Interventional2020-12-01Completed
Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia [NCT00588731]Phase 241 participants (Actual)Interventional2009-02-28Completed
Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES). [NCT04721691]Phase 134 participants (Anticipated)Interventional2021-03-10Recruiting
CBD Cannabis Extract: Pharmacokinetic Studies [NCT04280289]Early Phase 110 participants (Anticipated)Interventional2020-12-01Not yet recruiting
An Exploratory, Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder [NCT04745026]Phase 2160 participants (Anticipated)Interventional2021-05-31Active, not recruiting
A Randomised Controlled Trial of Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal [NCT04205682]Early Phase 152 participants (Anticipated)Interventional2020-01-31Not yet recruiting
Evaluation of the Antipsychotic Efficacy of the Phytocannabinoid Cannabidiol in Treating Acute Schizophrenic Psychosis. A Double-Blind, Controlled Clinical Trial [NCT00628290]Phase 242 participants (Anticipated)Interventional2002-10-31Completed
A Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy [NCT02607904]Phase 230 participants (Actual)Interventional2016-12-15Completed
Evaluation of Cannabidiol for Reduction of Brain Neuroinflammation [NCT05066308]Phase 280 participants (Anticipated)Interventional2022-01-04Recruiting
A Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut Syndrome [NCT04611438]Phase 3107 participants (Anticipated)Interventional2020-03-30Recruiting
Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation [NCT01385124]Phase 1/Phase 230 participants (Anticipated)Interventional2012-09-30Recruiting
Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy [NCT04044729]Early Phase 152 participants (Anticipated)Interventional2020-03-16Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Multiple Crossover N-of-1 Study Design of the Use of Medicinal Cannabis Oil-Based Extracts for Symptom Management in Cancer Patients [NCT03948074]Phase 2150 participants (Anticipated)Interventional2021-02-01Recruiting
Sex Differences in Neural Response to Cannabidiol [NCT04777643]Early Phase 119 participants (Actual)Interventional2022-06-07Completed
A Controlled-Dose Study Using A One Time Low Dose Cannabidiol Tablet For The Treatment of Mild to Moderate Musculoskeletal Pain [NCT04193631]Phase 116 participants (Actual)Interventional2019-12-07Completed
Physiological and Appetitive Effects of Four Weeks of 60 mg/Day CBD Supplementation in an Adult Population [NCT05774574]30 participants (Anticipated)Interventional2023-01-20Recruiting
A Phase IIa/b, Randomised, Double-blind, Placebo-controlled, Single-site, Parallel Group Clinical Trial to Examine Cannabidiol (CBD) as a Pharmacological Treatment for Cannabis Dependence. [NCT02044809]Phase 282 participants (Actual)Interventional2014-03-31Completed
A Randomized, Open-Label Trial on the Effects of Cannabidiol Isolate on Menstrual-Related Symptoms [NCT05679830]Phase 233 participants (Actual)Interventional2020-09-23Completed
Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease [NCT01037322]Phase 1/Phase 220 participants (Actual)Interventional2010-01-31Completed
Effectiveness of a Combined Therapy With Paravertebral Oxygen-ozone Injections and Topical Patch Containing Cannabidiol and β-Caryophyllene for Treatment of Neck Pain: a Prospective, Randomized, Controlled Trial. [NCT06099171]Phase 352 participants (Anticipated)Interventional2024-02-01Not yet recruiting
A Phase 4, Interventional, Multicenter, Open-Label, Single-Arm Study to Assess Behavioral and Other Co-occurring Outcomes Following Treatment With EPID(I/Y)OLEX as Add-on Therapy in Participants (Aged 1 to 65 Years Old) With Seizures Associated With Tuber [NCT05864846]Phase 475 participants (Anticipated)Interventional2023-06-29Recruiting
Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome: A Phase II Trial [NCT04447846]Phase 211 participants (Actual)Interventional2019-10-14Completed
Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use [NCT04105231]Phase 2130 participants (Anticipated)Interventional2021-06-01Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome [NCT02844933]Phase 27 participants (Actual)Interventional2018-05-09Terminated(stopped due to Insys Therapeutics filed Chapter 11 and terminated all studies.)
Cannabidiol Treatment for Severe and Critical COVID-19 Pulmonary Infection [NCT04731116]Phase 1/Phase 240 participants (Anticipated)Interventional2021-01-10Recruiting
The Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III Trial [NCT04613102]Phase 2/Phase 30 participants (Actual)Interventional2020-08-01Withdrawn(stopped due to The study protocol should to be updated (major updates), following the second Health Canada review /requests. The study has been withdrawn form the REB review and will not be performed at SickKids.)
Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint. [NCT04609748]Phase 230 participants (Anticipated)Interventional2021-01-27Recruiting
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study, Evaluating the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution in Subjects With Social Anxiety Disorder [NCT05600114]Phase 2225 participants (Anticipated)Interventional2022-10-27Active, not recruiting
A Phase I/II, Randomized, Double-blind, Placebo-controlled, Single-center Study of the Effects of Cannabidiol (CBD) on Opioid Plasma Levels in Participants With Chronic Radiculopathic Pain Syndromes Maintained on Chronic Opioid Therapy (COT) [NCT04760613]Phase 1/Phase 214 participants (Actual)Interventional2022-02-03Completed
A Phase II, Blinded, Randomised, Placebo Controlled Clinical Trial to Determine the Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis [NCT05942911]Phase 2128 participants (Anticipated)Interventional2023-11-22Recruiting
The Effects of Topical Cannabidiol on Paramedian Forehead Flap Scar Healing: A Split Scar Study [NCT05650697]Early Phase 110 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Multicenter, Open-Label, Flexible Dose Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures [NCT03355300]Phase 211 participants (Actual)Interventional2018-02-20Terminated(stopped due to Insys Therapeutics filed Chapter 11 and terminated all studies.)
Investigation of the Pharmacokinetic Profile of CBD [NCT05023070]Phase 124 participants (Anticipated)Interventional2021-07-22Active, not recruiting
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder [NCT05457465]Phase 225 participants (Anticipated)Interventional2023-06-01Recruiting
Effects of Cannabidiol (CBD) on the Brain [NCT04831294]15 participants (Actual)Interventional2021-07-15Active, not recruiting
Evaluation of Potential Central Glucoregulatory Compounds to Treat/Ameliorate the Symptoms of Schizophrenia: a Proof-of-concept Study in Healthy Volunteers. [NCT00916201]Phase 186 participants (Anticipated)Interventional2020-06-30Not yet recruiting
A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma [NCT05629702]Phase 2234 participants (Anticipated)Interventional2023-02-03Recruiting
CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level [NCT05209867]Phase 44 participants (Actual)Interventional2022-05-01Completed
Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation in Patients With Severe Alcohol Use Disorder: A Phase II Trial [NCT05860699]Phase 2210 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Chronic Effects of Effective Oral Cannabidiol Delivery on 24-hour Ambulatory Blood Pressure and Vascular Outcomes in Treated and Untreated Hypertension: A Randomized, Placebo-controlled and Crossover Study [NCT05346562]Phase 170 participants (Actual)Interventional2022-04-08Completed
Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota [NCT05285449]30 participants (Actual)Interventional2022-02-09Active, not recruiting
Effects of Cannabidiol on Memory Reconsolidation and Trauma-Related Symptoms: A Randomized Clinical Trial [NCT05892276]120 participants (Anticipated)Interventional2024-08-31Suspended(stopped due to The UT IRB determined that CBD oil is being used as a drug as defined by the FDA. Therefore, an IND must be obtained for the use of CBD oil in this research study in accordance with FDA regulations, 21 CFR 312.)
Open-Label, Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome [NCT05149898]Phase 1/Phase 220 participants (Actual)Interventional2020-03-03Completed
Endocannabinoid Control of Microglia Activation as a New Therapeutic Target in the Treatment of Schizophrenia [NCT02932605]32 participants (Actual)Interventional2017-11-03Completed
Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers [NCT05022186]Phase 490 participants (Anticipated)Interventional2021-04-01Recruiting
Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients. [NCT05646459]Phase 10 participants (Actual)Interventional2019-06-30Withdrawn(stopped due to Study was unable to obtain IRB approval because CBD was not legal in Nebraska at that time.)
A Randomised, Partially-blind, Placebo-controlled, Pilot, Dose-ranging Study To Assess The Effect Of Cannabidiol (CBD) On Liver Fat Levels In Subjects With Fatty Liver Disease. [NCT01284634]Phase 225 participants (Actual)Interventional2011-05-03Completed
Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus [NCT05490511]Phase 172 participants (Anticipated)Interventional2022-10-31Recruiting
A Randomized, Double-blind, Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients [NCT05753007]Phase 236 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder [NCT03787628]Phase 260 participants (Anticipated)Interventional2022-05-19Recruiting
A Randomized Controlled Pilot Study of the Use of Cannabidiol in the Management of Endometriosis Pain [NCT04527003]Phase 336 participants (Anticipated)Interventional2020-12-04Recruiting
A Randomized, Double-blind, Placebo-controlled, Multisite, Phase 3 Study to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P) in Children and Adolescents With Epilepsy With Myoclonic-Atonic Seizures [NCT05288283]Phase 33 participants (Actual)Interventional2022-10-31Terminated(stopped due to The study was terminated due to a business decision.)
A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease [NCT03582137]Phase 274 participants (Actual)Interventional2018-09-17Completed
Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes [NCT03215940]Early Phase 175 participants (Anticipated)Interventional2018-02-01Recruiting
Does Cannabidiol Attenuate the Acute Effects of ∆9-tetrahydrocannabinol Intoxication in Individuals Diagnosed With Schizophrenia? A Double-blind, Randomised, Placebo-controlled Experimental Study [NCT04605393]36 participants (Actual)Interventional2021-01-01Completed
Efficacy of Cannabidiol in Treatment of Pain Due to Symptomatic Osteoarthritis of the Knee: A Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT04607603]Phase 486 participants (Actual)Interventional2020-10-13Completed
Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant [NCT06113237]50 participants (Anticipated)Observational2024-01-31Not yet recruiting
Cannabidiol Adjunctive Therapy for Acute Bipolar Depression: A Randomized Double-Blind, Placebo Controlled Trial [NCT05867849]Phase 3360 participants (Anticipated)Interventional2023-10-15Recruiting
Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder [NCT05317546]Phase 250 participants (Anticipated)Interventional2022-10-01Recruiting
Safety and Efficacy of CBD (Epidiolex) in Idiopathic Generalized Epilepsy With Typical Absence Seizures [NCT04899050]Phase 414 participants (Actual)Interventional2021-07-30Completed
Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction [NCT04396730]Phase 49 participants (Actual)Interventional2020-04-08Completed
A Randomised, Double Blind, Placebo Controlled, Parallel Group, Pilot Study of 1:1 and 20:1 Ratio of Formulated GWP42003 : GWP42004 Plus GWP42003 and GWP42004 Alone in the Treatment of Dyslipidaemia in Subjects With Type 2 Diabetes [NCT01217112]Phase 262 participants (Actual)Interventional2010-10-31Completed
Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana [NCT01844687]Phase 250 participants (Actual)Interventional2013-05-31Completed
Cannabidiol (CBD) Cannabis Extract Oral Solution for Drug Resistant Pediatric Epilepsy (Expanded Access Use) [NCT03676049]0 participants Expanded AccessAvailable
Cannabidiol and Autonomic Function in Individuals at Rest [NCT04731779]Early Phase 118 participants (Actual)Interventional2021-08-30Completed
A Phase I/Ib Study on the Safety of Epidiolex in Patients With Prostate Cancer With Rising PSA After Localized Therapy With Either Surgery or Radiation [NCT04428203]Phase 121 participants (Actual)Interventional2020-08-03Completed
Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial [NCT04360044]Phase 292 participants (Actual)Interventional2020-11-20Completed
Cannabidiol on reward-and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder: A Double-blind, Placebo-controlled, Cross-over Trial [NCT04982029]Phase 215 participants (Actual)Interventional2022-04-14Completed
An Open-Label Trial of Epidiolex in the Treatment of Obsessive Compulsive Disorder and Related Disorders: Proof of Concept Study [NCT04978428]Phase 215 participants (Anticipated)Interventional2022-04-14Recruiting
An Assessment of the Drug Interaction Potential Between Oral Cannabidiol (Epidiolex®) and the CES1 Substrate Methylphenidate in Healthy Volunteers [NCT04603391]Phase 412 participants (Actual)Interventional2021-02-25Completed
Endocannabinoid System Engagement to Reduce Anxiety Reactivity With Cannabidiol in Social Anxiety Disorder (R61 Project) [NCT05823753]Phase 260 participants (Anticipated)Interventional2023-04-19Recruiting
A Phase II Trial of Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy [NCT04582591]Phase 254 participants (Actual)Interventional2021-03-03Active, not recruiting
A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol [NCT00309413]Phase 229 participants (Actual)Interventional2006-03-31Completed
A Double Blind, Randomized, Cross Over, Placebo Controlled Phase 2 Clinical Trial to Asses Neuroprotection by Cannabinoids in Huntington's Disease [NCT01502046]Phase 225 participants (Actual)Interventional2011-09-30Completed
The Use of Cannabis (Marijuana) and Cannabidiol (CBD) Among Cancer Patients: A Pilot Study [NCT05836857]100 participants (Anticipated)Observational2023-01-30Recruiting
Are Natural Killer Cells Novel Mediators of the Effects of Cannabidiol on Physical Fitness, Mental Health and Well-Being, Sleep Quantity, Sleep Quantity and Immune Function? [NCT04881539]50 participants (Actual)Interventional2021-05-15Completed
Cannabidiol Effects on Cardiovascular System and Exercise Responses [NCT05232123]Early Phase 160 participants (Anticipated)Interventional2023-07-31Suspended(stopped due to waiting on funding)
Sativex Associated With Behavioral-relapse Prevention Strategy as Treatment for Cannabis Dependence [NCT01747850]Phase 245 participants (Actual)Interventional2013-03-31Completed
Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation [NCT05032807]Phase 114 participants (Actual)Interventional2022-07-01Completed
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC) [NCT04349930]Phase 10 participants (Actual)Interventional2021-01-31Withdrawn(stopped due to Need to obtain IND approval.)
Long-term Follow-up of a Multicentre, Non-interventional, Prospective Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting [NCT05772429]150 participants (Anticipated)Observational2023-04-17Recruiting
The Effect of Cannabidiol in Learning and Memory of Adults [NCT06074172]Phase 257 participants (Actual)Interventional2020-03-14Completed
A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy [NCT05672342]Early Phase 1120 participants (Anticipated)Interventional2023-12-06Not yet recruiting
The Role of Cannabidiol in Regulating Meal Time Anxiety in Anorexia Nervous: Safety, Tolerability and Pharmacokinetics [NCT04878627]Early Phase 140 participants (Anticipated)Interventional2022-01-20Recruiting
A Multicenter, Randomized, Double-blind, Placebo- Controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Dravet Syndrom [NCT02318563]Phase 30 participants (Actual)Interventional2017-12-30Withdrawn(stopped due to Sponsor elected not to continue with study.)
A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol (GWP42003-P) [NCT02565108]Phase 220 participants (Actual)Interventional2016-01-20Completed
A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol (GWP42003-P) [NCT02564952]Phase 218 participants (Actual)Interventional2016-03-11Completed
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures [NCT02544750]Phase 3199 participants (Actual)Interventional2016-08-31Completed
Randomized, Double Blind Clinical Trial to Study the Effect of Cannabidiol (CBD) 133mg + Cannabigerol (CBG) 66mg + Tetrahydrocannabinol (THC) 4mg a Day as Adjunctive Therapy in the Treatment of Chronic Migraine - CAMTREA TRIAL [NCT04989413]Phase 4110 participants (Anticipated)Interventional2022-10-18Recruiting
Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients [NCT03233633]Phase 166 participants (Actual)Interventional2017-05-10Completed
A Phase 2a Open Label, Single Arm Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis [NCT04129489]Phase 22 participants (Actual)Interventional2019-02-07Terminated(stopped due to low recruitment)
The Use of Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis. A Double-Blind, Randomized Control Study [NCT05020028]Phase 2/Phase 3100 participants (Anticipated)Interventional2022-06-22Recruiting
Cannabis Use, Cognition, and the Endocannabinoid System in HIV [NCT04883255]Early Phase 1138 participants (Anticipated)Interventional2023-05-03Recruiting
A Phase 1/2 Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Pharmaceutical Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Seizure Disorders [NCT02324673]Phase 1/Phase 261 participants (Actual)Interventional2015-04-13Completed
Characterisation of Relative Bioavailability of GLA-015 in Comparison With an Oily Cannabidiol Solution (NRF 22.10) - a Multiple Dose, Randomised, 2-period Crossover-trial With Twice Daily Administration in Healthy Adult Male and Female Subjects [NCT04790136]Phase 118 participants (Actual)Interventional2021-03-17Completed
Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy [NCT02660255]0 participants Expanded AccessApproved for marketing
Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users [NCT01748799]16 participants (Actual)Interventional2013-02-28Completed
Evaluation of a Specific Transdermal Cannabidiol Product for Chronic Musculoskeletal Joint Pain. [NCT05002114]Phase 10 participants (Actual)Interventional2023-01-31Withdrawn(stopped due to there were issues with the primary study material that prohibited continuation at this time)
Cannabidiol Treatment in Patients With Early Psychosis [NCT02504151]Phase 218 participants (Actual)Interventional2016-01-28Completed
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures [NCT02544763]Phase 3224 participants (Actual)Interventional2016-04-06Completed
Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation [NCT01596075]Phase 1/Phase 240 participants (Anticipated)Interventional2012-07-31Recruiting
The CANabidiol Use for RElief of Short Term Insomnia (CAN-REST). A Randomised, Double-Blind, Placebo-Controlled Clinical Study [NCT05253417]Phase 2208 participants (Actual)Interventional2022-05-01Completed
A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study [NCT02953548]Phase 39 participants (Actual)Interventional2017-04-24Completed
Evaluation of Hemp-Derived Botanical Dietary Supplementation to Promote Healthy Brain Function During Recovery From Brain Injury [NCT03826368]0 participants (Actual)Observational2020-04-13Withdrawn(stopped due to Lack of initial funding after approval of study)
An Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut Syndrome [NCT03467113]Phase 19 participants (Actual)Interventional2018-01-19Completed
A Double-blind, Randomised, Placebo-controlled, Parallel Group Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder [NCT02006628]Phase 288 participants (Actual)Interventional2014-02-25Completed
Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome [NCT02332655]Phase 1/Phase 25 participants (Actual)Interventional2014-12-31Completed
A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution [NCT05044819]Phase 4150 participants (Anticipated)Interventional2021-07-07Recruiting
A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome [NCT03614663]Phase 2/Phase 3212 participants (Actual)Interventional2018-06-12Completed
Cannabidiol for Treating PTSD Symptoms and Neurocognitive Impairment in PTSD and PTSD Comorbid With TBI: A Placebo-controlled RCT With Neural-circuit Centered Precision Medicine Prediction of Response. [NCT04550377]Phase 2120 participants (Anticipated)Interventional2021-05-26Recruiting
Cannabidiol as a Treatment for Alcohol Use Disorder Comorbid With Posttraumatic Stress Disorder [NCT03248167]Phase 1/Phase 295 participants (Actual)Interventional2019-09-16Completed
Reducing Pain and Opioid Use With CBD [NCT05299944]Phase 2150 participants (Anticipated)Interventional2022-03-08Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults. [NCT02224560]Phase 3225 participants (Actual)Interventional2015-06-08Completed
Effects of Cannabidiol on Responses to Emotional Stimuli [NCT02902081]38 participants (Actual)Interventional2013-02-28Completed
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia [NCT03941288]Phase 2111 participants (Actual)Interventional2019-09-04Completed
Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain [NCT04587791]Early Phase 140 participants (Anticipated)Interventional2021-12-08Recruiting
A Controlled Study of the Effect of Cannabis on Visual Functions in Healthy Subjects and in Retinitis Pigmentosa Patients [NCT03078309]Early Phase 150 participants (Anticipated)Interventional2018-09-01Recruiting
Cannabidiol for Fibromyalgia -The CANNFIB Trial Protocol for a Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial [NCT04729179]Phase 3200 participants (Anticipated)Interventional2021-03-01Recruiting
An Open Label, Multi-Center Study to Investigate the Safety of Cannabinoid (GWP42003-P) in Children With Medication Resistant Epilepsy [NCT02397863]0 participants Expanded Access2014-12-31Available
A Phase 2 Study to Assess the Efficacy and Safety of Cannabidiol Oral Solution for the Treatment of Refractory Infantile Spasms [NCT02551731]Phase 29 participants (Actual)Interventional2016-01-27Terminated(stopped due to Sponsor elected not to continue with study)
The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis [NCT03172741]Phase 2/Phase 30 participants (Actual)Interventional2017-01-31Withdrawn(stopped due to Did not pursue study)
University of Alabama at Birmingham (UAB) Pediatric CBD Program [NCT02695537]Phase 189 participants (Actual)Interventional2015-04-30Completed
A Multicenter, Open-Label Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi Syndrome [NCT03458416]Phase 22 participants (Actual)Interventional2018-09-06Terminated(stopped due to Insys Therapeutics filed Chapter 11 and terminated all studies.)
Bioequivalence Assessment of Cannabidiol (CBD) Administrated in Oral Formulations [NCT03877991]Early Phase 112 participants (Actual)Interventional2019-05-02Completed
Cannabidiol as Treatment Intervention for Opioid Relapse [NCT01605539]Phase 210 participants (Actual)Interventional2012-05-31Completed
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile Spasms [NCT03421496]Phase 32 participants (Actual)Interventional2018-09-05Terminated(stopped due to The study was terminated due to slow enrollment and failure to identify adequate patients that met entry criteria.)
Population Pharmacokinetics of Antiepileptic in Pediatrics [NCT03196466]1,000 participants (Anticipated)Observational2017-06-19Recruiting
Bioequivalence Assessment of Oral Administration Vs. Oral Spray of a Cannabinoid Combination (Δ9 -Tetrahydrocannabinol (THC) and Cannabidiol (CBD) In 1:1 Ratio) [NCT01893424]Phase 112 participants (Actual)Interventional2013-08-31Completed
A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy. [NCT00530764]Phase 2360 participants (Actual)Interventional2007-11-30Completed
Investigating the Effects of Cannabidiol on Social Anxiety Disorder [NCT05649059]Phase 450 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET). [NCT03805750]Phase 1/Phase 27 participants (Actual)Interventional2019-01-22Completed
The Pharmacokinetics of Oral Tetrahydrocannabinol and Cannabidiol Across the Spectrum of Glomerular Filtration Rate: a PharmacoKinetic Study [NCT05742724]Phase 124 participants (Anticipated)Interventional2023-01-11Recruiting
Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi [NCT04387617]Phase 2/Phase 390 participants (Actual)Interventional2021-02-15Completed
A Phase 1/2, Safety, Tolerability, and Dose-Finding Study of Cannabidiol for Drug-Resistant Epilepsies [NCT03014440]0 participants Expanded AccessNo longer available
Cannabidiol Effects on Fear Extinction in Social Phobia [NCT06123702]Early Phase 120 participants (Anticipated)Interventional2023-11-30Not yet recruiting
Anxiety Symptoms in Relation to Use of Hemp-Derived, Full Spectrum Cannabidiol (CBD): a Cohort Study [NCT05023759]30 participants (Actual)Observational2020-06-01Completed
Why Antiprogestrone (Mifepristone) and Cyp 26 Inhibitor Must be Combined With Tamoxifen or ( Tamoxifen and Retinoic Acid) for Treating Early Breast Cancer [NCT05016349]Phase 3160 participants (Anticipated)Interventional2021-08-31Not yet recruiting
CAnnabidiol Study in Children With Autism Spectrum DisordEr (CASCADE): A Double-Blind, Placebo-Controlled Study to Investigate Efficacy and Safety of Cannabidiol in Children and Adolescents With Autism [NCT04520685]Phase 270 participants (Anticipated)Interventional2021-12-15Recruiting
An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome [NCT03802799]Phase 2/Phase 3450 participants (Anticipated)Interventional2018-11-09Enrolling by invitation
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Knee Arthroscopic Surgery [NCT05934500]Early Phase 1100 participants (Anticipated)Interventional2023-10-15Not yet recruiting
Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study [NCT04423341]Phase 2/Phase 312 participants (Actual)Interventional2020-05-20Completed
Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial [NCT05632627]Phase 2120 participants (Anticipated)Interventional2023-04-11Recruiting
Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation [NCT05456113]48 participants (Anticipated)Interventional2024-12-01Enrolling by invitation
Cannabidiol in the Treatment of Opioid Use Disorder [NCT05269706]Phase 2200 participants (Actual)Interventional2022-05-18Active, not recruiting
A Retrospective Cohort Study to Evaluate the Effects of Cannabidiol (CBD)-Containing Test Products on Anxiety Among Women in the U.S. [NCT05108220]1,350 participants (Actual)Observational2020-10-15Completed
A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of [NCT02318602]Phase 352 participants (Actual)Interventional2016-01-08Completed
Oral Cannabidiol for Tobacco Cessation [NCT05445804]Phase 150 participants (Anticipated)Interventional2022-11-01Recruiting
Evaluation of the Efficacy of CANNABIDIOL on the Pruritus in Children With Hereditary Epidermolysis Bullosa [NCT05651607]Phase 210 participants (Anticipated)Interventional2023-07-06Recruiting
Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study [NCT03471559]Phase 18 participants (Actual)Interventional2018-12-10Terminated(stopped due to Two step study, step two was not feasible based on results from phase one.)
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults. [NCT02224690]Phase 3171 participants (Actual)Interventional2015-04-28Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Lennox-Gastaut [NCT02318537]Phase 30 participants (Actual)Interventional2017-12-30Withdrawn(stopped due to Sponsor elected not to continue with study.)
CBD/THC Solution as a Pharmacological Strategy for Patients With Fibromyalgia. Single-center, Double-blind, Randomized, Placebo-controlled Clinical Trial Protocol (FibroCann) [NCT05283161]Phase 2/Phase 340 participants (Anticipated)Interventional2022-04-15Not yet recruiting
Reducing the Harmful Effects of Cannabis Use: Finding the Optimal CBD:THC Ratio [NCT05170217]46 participants (Actual)Interventional2017-11-08Completed
The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence: An Exploratory Pilot Study [NCT05387148]Phase 220 participants (Anticipated)Interventional2022-06-30Recruiting
Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis: Understanding the Mechanism and Mediators of Action [NCT04411225]Phase 3120 participants (Anticipated)Interventional2021-07-01Recruiting
The Effects of Cannabidiol on the Driving Ability of Healthy Adults: a Clinical Trial [NCT04590495]Phase 240 participants (Actual)Interventional2021-04-01Completed
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome. [NCT02224703]Phase 3199 participants (Actual)Interventional2015-04-13Completed
A Double Blind, Placebo-controlled, Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome [NCT02091206]Phase 234 participants (Actual)Interventional2014-10-22Completed
Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias [NCT04754399]Phase 240 participants (Actual)Interventional2021-04-16Completed
The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults. [NCT03295903]Early Phase 124 participants (Anticipated)Interventional2018-01-01Active, not recruiting
Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling (Bonsai Study) wIth COVID-19: a Randomised Controlled Trial [NCT04504877]Phase 2/Phase 3120 participants (Actual)Interventional2020-06-16Completed
A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome [NCT02091375]Phase 3120 participants (Actual)Interventional2015-03-30Completed
Study to Evaluate the Efficacy and Safety of CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors A Double-blind, Placebo-controlled Trial [NCT04615949]Phase 2/Phase 390 participants (Actual)Interventional2021-04-30Terminated(stopped due to The changing nature of COVID-19 including a more vaccinated population, increasing natural population immunity, milder variants and other related factors has meant that it is no longer realistic to recruit the patients in a reasonable time frame.)
A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis [NCT01562314]Phase 260 participants (Actual)Interventional2012-05-09Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00530764 (9) [back to overview]Change in Brief Pain Inventory - Short Form (BPI-SF)
NCT00530764 (9) [back to overview]Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)
NCT00530764 (9) [back to overview]Change in Montgomery Asberg Depression Rating Scale (MADRS)
NCT00530764 (9) [back to overview]Change in Mean Daily NRS Pain Score (Worst Pain).
NCT00530764 (9) [back to overview]Change in Cumulative Average Pain Response Curves
NCT00530764 (9) [back to overview]Change in Mean Daily NRS Pain Score (Average Pain).
NCT00530764 (9) [back to overview]Change in Patient Global Impression of Change - PGIC
NCT00530764 (9) [back to overview]Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline
NCT00530764 (9) [back to overview]Change in Sleep Disruption NRS
NCT00588731 (2) [back to overview]Overall Cognition as Measured on the MATRICS Battery
NCT00588731 (2) [back to overview]Verbal Short Term Memory
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)
NCT01217112 (44) [back to overview]The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]Adverse Events as a Measure of Patient Safety
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
NCT01217112 (44) [back to overview]The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
NCT01284634 (6) [back to overview]Change From Baseline To The EOT In Mean Serum Triglyceride Levels
NCT01284634 (6) [back to overview]Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels
NCT01284634 (6) [back to overview]Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio
NCT01284634 (6) [back to overview]Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
NCT01284634 (6) [back to overview]Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels
NCT01284634 (6) [back to overview]Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels
NCT01562314 (18) [back to overview]Number Of Participants Who Reported An Improvement In The Subject Global Impression Of Change (SGIC) Questionnaire At EOT
NCT01562314 (18) [back to overview]Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency NRS - PP Analysis
NCT01562314 (18) [back to overview]Number Of Participants Who Reported An Improvement In The SGIC Questionnaire At EOT - PP Analysis
NCT01562314 (18) [back to overview]Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency Numerical Rating Scale (NRS)
NCT01562314 (18) [back to overview]Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT
NCT01562314 (18) [back to overview]Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT - PP Analysis
NCT01562314 (18) [back to overview]Change From Baseline To EOT In Levels Of Fecal Calprotectin
NCT01562314 (18) [back to overview]Change From Baseline To EOT In Levels Of Fecal Calprotectin- PP Analysis
NCT01562314 (18) [back to overview]Change From Baseline To EOT In The IBDQ Total Score - PP Analysis
NCT01562314 (18) [back to overview]Change From Baseline To EOT In The Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
NCT01562314 (18) [back to overview]Change From Baseline To EOT In The Mayo Partial Score
NCT01562314 (18) [back to overview]Change From Baseline To EOT In The Mayo Partial Score - PP Analysis Set
NCT01562314 (18) [back to overview]Change From Baseline To EOT In The Mayo Total Score
NCT01562314 (18) [back to overview]Change From Baseline To EOT In The Mayo Total Score - PP Analysis
NCT01562314 (18) [back to overview]Change From Baseline To EOT In The PGAS Score
NCT01562314 (18) [back to overview]Change From Baseline To EOT In The PGAS Score - PP Analysis
NCT01562314 (18) [back to overview]Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS
NCT01562314 (18) [back to overview]Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS - PP Analysis
NCT01605539 (9) [back to overview]Visual Analog Scale for Anxiety (VASA)
NCT01605539 (9) [back to overview]The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data
NCT01605539 (9) [back to overview]The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data
NCT01605539 (9) [back to overview]Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)
NCT01605539 (9) [back to overview]Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)
NCT01605539 (9) [back to overview]Vital Signs - Blood Pressure
NCT01605539 (9) [back to overview]Vital Signs - Heart Rate
NCT01605539 (9) [back to overview]Vital Signs - Respiratory Rate
NCT01605539 (9) [back to overview]Vital Signs - Temperature
NCT01747850 (5) [back to overview]Withdrawal
NCT01747850 (5) [back to overview]Cannabis Use (in Days)
NCT01747850 (5) [back to overview]Tolerability
NCT01747850 (5) [back to overview]Cannabis Use (Grams)
NCT01747850 (5) [back to overview]Cannabis Craving
NCT01748799 (3) [back to overview]Cannabis Withdrawal
NCT01748799 (3) [back to overview]Feasibility
NCT01748799 (3) [back to overview]Tolerability of Sativex in Persons That Are Cannabis Dependent
NCT01844687 (7) [back to overview]Plasma Concentration of CBD
NCT01844687 (7) [back to overview]Mood Scale - Subscale 'Feeling High'
NCT01844687 (7) [back to overview]Marijuana Rating Form - Strength
NCT01844687 (7) [back to overview]Number of Optional Puffs of MJ Cigarette Taken
NCT01844687 (7) [back to overview]Marijuana Rating Form - Like
NCT01844687 (7) [back to overview]Optional Additional Puffs of MJ Cigarette
NCT01844687 (7) [back to overview]Heart Rate
NCT02006628 (8) [back to overview]Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)
NCT02006628 (8) [back to overview]Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)
NCT02006628 (8) [back to overview]Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)
NCT02006628 (8) [back to overview]Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score
NCT02006628 (8) [back to overview]Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score
NCT02006628 (8) [back to overview]Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score
NCT02006628 (8) [back to overview]Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score
NCT02006628 (8) [back to overview]Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score
NCT02091206 (3) [back to overview]Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22
NCT02091206 (3) [back to overview]Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)
NCT02091206 (3) [back to overview]Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations
NCT02091375 (11) [back to overview]Number Of Participants With Inpatient Hospitalizations Due To Epilepsy
NCT02091375 (11) [back to overview]Change From Baseline In Sleep Disruption 0 To 10 Numerical Rating Scale (0 to 10 NRS) Score
NCT02091375 (11) [back to overview]Change From Baseline In Quality Of Life In Childhood Epilepsy (QOLCE) Score
NCT02091375 (11) [back to overview]Change From Baseline In Epworth Sleepiness Scale (ESS) Score
NCT02091375 (11) [back to overview]Number Of Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period
NCT02091375 (11) [back to overview]Caregiver Global Impression Of Change In Seizure Duration (CGICSD)
NCT02091375 (11) [back to overview]Change From Baseline In Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score
NCT02091375 (11) [back to overview]Percentage Change From Baseline In Non-Convulsive Seizure Frequency During The Treatment Period
NCT02091375 (11) [back to overview]Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period
NCT02091375 (11) [back to overview]Number Of Participants Using Rescue Medication
NCT02091375 (11) [back to overview]Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period
NCT02224560 (4) [back to overview]Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period
NCT02224560 (4) [back to overview]Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period
NCT02224560 (4) [back to overview]Subject/Caregiver Global Impression Of Change (S/CGIC) Assessment
NCT02224560 (4) [back to overview]Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Both Hands Z Score)
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Dominant Hand Z Score)
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Non Dominant Hand Z Score)
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Quality of Life in Childhood Epilepsy (QOLCE) Scores
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Red Blood Cells (RBCs) Values
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Visual Perception Standard Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WASI-II Matrix Reasoning T Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Abbreviated Scale of Intelligence (WASI)-II Vocabulary T Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Adult Intelligence Scale (WAIS) Coding Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Intelligence Scale for Children (WISC) Coding Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Backward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Forward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Backward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Forward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Receptive Vocabulary T Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment QOL in Epilepsy Scores (QOLIE-31-P) in Participants With Lennox-Gastaut Syndrome
NCT02224573 (67) [back to overview]Mean Subject/Caregiver Global Impression of Change (S/CGIC) Score
NCT02224573 (67) [back to overview]Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Albumin and Protein
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, and Gamma Glutamyl Transferase
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine (Jaffe), Creatinine (Enzymatic), and Bilirubin
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine Clearance (Schwartz) and Creatinine Clearance (Cockcroft-Gault)
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs)
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Preschool & Primary Scale of Intelligence (WPPSI)-IV Bug Search T Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Matrix Reasoning T Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Matrix Reasoning T Score
NCT02224573 (67) [back to overview]Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group
NCT02224573 (67) [back to overview]Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose
NCT02224573 (67) [back to overview]Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus)
NCT02224573 (67) [back to overview]Number of Participants With Inpatient Hospitalizations Due to Epilepsy Since the Previous Visit
NCT02224573 (67) [back to overview]Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose
NCT02224573 (67) [back to overview]Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures
NCT02224573 (67) [back to overview]Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures
NCT02224573 (67) [back to overview]Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome
NCT02224573 (67) [back to overview]Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome
NCT02224573 (67) [back to overview]Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency
NCT02224573 (67) [back to overview]Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency
NCT02224573 (67) [back to overview]Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD)
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Hemoglobin
NCT02224573 (67) [back to overview]Mean Pediatric Cannabinoid Withdrawal Scale (PCWS) Score at the End of Treatment, the End of Taper, the Post-Taper Safety Call, and at Safety Follow-up
NCT02224573 (67) [back to overview]Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in a Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Body Mass Index (BMI)
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Letter Sequencing Completion Time Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Motor Speed Completion Time Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number Sequencing Completion Time Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number-letter Switching Completion Time Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Delis-Kaplan Executive Function System (D-KEFS) Visual Scanning Completion Time Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Volume
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Expressive One-Word Picture Vocabulary Test (EOWPVT) Scaled Score
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hematocrit Values
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hemoglobin Levels
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Insulin-like Growth Factor-1 (IGF-1) Levels
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prolactin
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin International Normalized Ratio
NCT02224573 (67) [back to overview]Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin Time
NCT02224690 (4) [back to overview]Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period
NCT02224690 (4) [back to overview]Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period
NCT02224690 (4) [back to overview]Subject/Caregiver Global Impression Of Change Assessment (S/CGIC)
NCT02224690 (4) [back to overview]Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period
NCT02224703 (3) [back to overview]Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period
NCT02224703 (3) [back to overview]Change In Total Seizures During The Treatment Period Compared To Baseline
NCT02224703 (3) [back to overview]Change In Convulsive Seizures During The Treatment Period Compared To Baseline
NCT02318602 (8) [back to overview]Percentage of Participants With Adverse Events
NCT02318602 (8) [back to overview]Vineland Adaptive Behavior Scales (VABS)
NCT02318602 (8) [back to overview]Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
NCT02318602 (8) [back to overview]Vineland Adaptive Behavior Scales (VABS)
NCT02318602 (8) [back to overview]Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values
NCT02318602 (8) [back to overview]Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT02318602 (8) [back to overview]Percentage of Participants With Serious Adverse Events
NCT02318602 (8) [back to overview]Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs
NCT02324673 (32) [back to overview]Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1
NCT02324673 (32) [back to overview]Dose Normalized AUC(0-inf) [AUC(0-inf)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol
NCT02324673 (32) [back to overview]Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT02324673 (32) [back to overview]Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1
NCT02324673 (32) [back to overview]Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10
NCT02324673 (32) [back to overview]Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]MRCmax on Day 10
NCT02324673 (32) [back to overview]Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT02324673 (32) [back to overview]Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Area Under the Plasma-Concentration Time Curve From 0 to 12 Hours Post-dose [AUC(0-12)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1
NCT02324673 (32) [back to overview]AUC From Time 0 to Infinity [AUC(0-inf)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]AUC From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] on Day 1 for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age
NCT02324673 (32) [back to overview]AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10
NCT02324673 (32) [back to overview]Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment
NCT02324673 (32) [back to overview]Change From Baseline in Daily Seizure Activity
NCT02324673 (32) [back to overview]Clinical Global Impression of Improvement (CGI-I) Assessment
NCT02324673 (32) [back to overview]Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol
NCT02324673 (32) [back to overview]Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1
NCT02324673 (32) [back to overview]Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10
NCT02332655 (2) [back to overview]Number of Seizures Per Month
NCT02332655 (2) [back to overview]Percentage Change in Seizure Frequency at Most Recent Visit on CBD Compared With Baseline
NCT02504151 (4) [back to overview]Positive and Negative Syndrome Scale (PANSS) Over Time
NCT02504151 (4) [back to overview]Quality of Life Scale (QLS) Over Time
NCT02504151 (4) [back to overview]Clinical Global Impression of Severity Scale Over Time
NCT02504151 (4) [back to overview]Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
NCT02544750 (6) [back to overview]Number of Participants Considered Treatment Responders During the OLE Treatment Period
NCT02544750 (6) [back to overview]Number of Participants With Any TEAE, by Severity
NCT02544750 (6) [back to overview]Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
NCT02544750 (6) [back to overview]Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period
NCT02544750 (6) [back to overview]Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period
NCT02544750 (6) [back to overview]Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period
NCT02544763 (5) [back to overview]Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration)
NCT02544763 (5) [back to overview]Number of Participants With Any Severe Treatment-emergent Adverse Event (TEAE)
NCT02544763 (5) [back to overview]Percent Change From Baseline in Total Seizures During the Treatment Period (Maintenance and Titration)
NCT02544763 (5) [back to overview]Change From Baseline in the Caregiver Global Impression of Change (CGIC) or Participant Global Impression of Change (PGIC) Score at the Participant's Last Visit
NCT02544763 (5) [back to overview]Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration)
NCT02551731 (9) [back to overview]Part A: Time to Complete Responder Relapse
NCT02551731 (9) [back to overview]Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs)
NCT02551731 (9) [back to overview]Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14
NCT02551731 (9) [back to overview]Part A: Percentage of Participants With Absence of Infantile Spasms at Day 14
NCT02551731 (9) [back to overview]Part A: Parent Impression of Efficacy and Tolerability of Study Drug
NCT02551731 (9) [back to overview]Part A: Percentage of Complete Responders With Relapse
NCT02551731 (9) [back to overview]Part A: Percentage of Participants Who Are Considered Complete Responders at Day 14
NCT02551731 (9) [back to overview]Part A: Percentage of Participants With a Partial Response to Treatment
NCT02551731 (9) [back to overview]Part A: Percentage of Participants With Absence of Hypsarrhythmia at Day 14
NCT02564952 (1) [back to overview]Number Of Participants Who Experienced Severe OLE-Emergent AEs
NCT02565108 (6) [back to overview]Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
NCT02565108 (6) [back to overview]PK: Geometric Mean Ratios Of CLB And N-CLB For AUCtau On Day 33 Compared With Day 1
NCT02565108 (6) [back to overview]PK: Time To The Maximum Plasma Concentration (Tmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
NCT02565108 (6) [back to overview]PK: Geometric Mean Ratios Of CLB And N-CLB For Cmax On Day 33 Compared With Day 1
NCT02565108 (6) [back to overview]PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
NCT02565108 (6) [back to overview]Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)
NCT02695537 (5) [back to overview]Number of Participants With Change in Laboratory Tests Considered by Managing Neurologists as Clinically Significant.
NCT02695537 (5) [back to overview]Number of Participants With Severe Adverse Events (Increase in Seizure Frequency by More Than 100% Leading to Emergency Room Visit or Hospitalization).
NCT02695537 (5) [back to overview]Change in Seizure Frequency as Measured in Total Number of Seizures Per Month.
NCT02695537 (5) [back to overview]Change in Seizure Severity Measured by the Chalfont Seizure Severity Scale (Duncan & Sander, 1991, JNNP).
NCT02695537 (5) [back to overview]Number of Participants With Change in Resting Blood Pressure or Heart Rate by 25% if Considered Significant by Managing Neurologist.
NCT02700412 (5) [back to overview]Change in Seizure Frequency as Measured in Total Number of Seizures Per Month.
NCT02700412 (5) [back to overview]Change in Seizure Severity Measured by the Chalfont Seizure Severity Scale (Duncan & Sander, 1991, JNNP).
NCT02700412 (5) [back to overview]Number of Participants With Change in Resting Blood Pressure or Heart Rate by 25% if Considered Significant by Managing Neurologist.
NCT02700412 (5) [back to overview]Number of Participants With Severe Adverse Events (SAEs) (Increase in Seizure Frequency by More Than 100% Leading to Emergency Room Visit or Hospitalization).
NCT02700412 (5) [back to overview]Number of Participants With Change in Laboratory Tests Considered by Managing Neurologists as Clinically Significant.
NCT02751359 (2) [back to overview]Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales
NCT02751359 (2) [back to overview]Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test
NCT02759185 (9) [back to overview]Baseline CAPS-5 Total Severity Score
NCT02759185 (9) [back to overview]Actigraph Change in Sleep Efficiency
NCT02759185 (9) [back to overview]Change in Inventory of Depression and Anxiety (IDAS) Social Anxiety Total Scores From Baseline to Stage 1 Primary Endpoint
NCT02759185 (9) [back to overview]Stage 1 Primary Endpoint CAPS-5 Total Severity Scores (Visit 5)
NCT02759185 (9) [back to overview]Change in PTSD Checklist (PCL-5) From Baseline to Stage 1 Primary Endpoint
NCT02759185 (9) [back to overview]Change in Inventory of Psychosocial Functioning (IPF) From Baseline to Stage 1 Primary Endpoint
NCT02759185 (9) [back to overview]Change in Inventory of Depression and Anxiety (IDAS) General Depression Total Scores From Baseline to Stage 1 Primary Endpoint
NCT02759185 (9) [back to overview]Change in Insomnia Severity Index (ISI) Scores From Baseline to Stage 1 Primary Endpoint
NCT02759185 (9) [back to overview]Change in CAPS-5 Total Severity Scores From Baseline to Stage 1 Primary Endpoint (Visit 5)
NCT02818777 (20) [back to overview]Number of Participants Had Changes in Orthostatic Blood Pressure
NCT02818777 (20) [back to overview]Severity of Participants Reporting Study-related Adverse Events at Each Dose Level
NCT02818777 (20) [back to overview]Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance
NCT02818777 (20) [back to overview]Change in Anxiety Short Form
NCT02818777 (20) [back to overview]Number of Participants Had Changes in Laboratory Values
NCT02818777 (20) [back to overview]Number of Participants Had Changes in Physical Exam
NCT02818777 (20) [back to overview]Change From Baseline of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
NCT02818777 (20) [back to overview]Change in Depression Short Form
NCT02818777 (20) [back to overview]Change in Emotional and Behavioral Dyscontrol Short Form
NCT02818777 (20) [back to overview]Change in Fatigue Severity Scale
NCT02818777 (20) [back to overview]Change in International Restless Legs Syndrome Study Group Rating Scale for Restless
NCT02818777 (20) [back to overview]Change in MDS-UPDRS Tremor Score (Total of Items 3.17 and 3.18) in the ON State
NCT02818777 (20) [back to overview]Change in Montreal Cognitive Assessment (MoCA)
NCT02818777 (20) [back to overview]Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score
NCT02818777 (20) [back to overview]Change in Neuropsychiatric Inventory (NPI)
NCT02818777 (20) [back to overview]Change in Pain Severity Form
NCT02818777 (20) [back to overview]Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
NCT02818777 (20) [back to overview]Change in Scales for Outcomes in Parkinson's Disease (SCOPA)-Sleep-night Time Sleep
NCT02818777 (20) [back to overview]Change in Unified Dyskinesia Rating Scale (UDysRS)
NCT02818777 (20) [back to overview]Number of Participants Had Changes in EKG
NCT02844933 (2) [back to overview]Change From Baseline In Total Body Weight
NCT02844933 (2) [back to overview]Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT)
NCT02902081 (1) [back to overview]Positivity Ratings of Social Images
NCT02953548 (16) [back to overview]Number of Responders
NCT02953548 (16) [back to overview]Number of Participants With Resolution of Hypsarrhythmia
NCT02953548 (16) [back to overview]Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)
NCT02953548 (16) [back to overview]Number of Participants Free of Clinical Spasms
NCT02953548 (16) [back to overview]Percentage of Participants Free of Clinical Spasms
NCT02953548 (16) [back to overview]Percentage of Participants With Resolution of Hypsarrhythmia
NCT02953548 (16) [back to overview]Percentage of Responders
NCT02953548 (16) [back to overview]Caregiver Clinical Global Impression of Change (CGIC)
NCT02953548 (16) [back to overview]Number of Participant With Any Clinically Relevant Urinalysis Parameter Value
NCT02953548 (16) [back to overview]Number of Participants Experiencing Spasms and Seizures by Subtype
NCT02953548 (16) [back to overview]Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value
NCT02953548 (16) [back to overview]Number of Participants With Clinically Significant Electrocardiogram Findings
NCT02953548 (16) [back to overview]Physician Global Impression of Change (PGIC)
NCT02953548 (16) [back to overview]Number of Participants With Clinically Significant Physical Examination Findings
NCT02953548 (16) [back to overview]Number of Participants With Clinically Significant Vital Sign Findings
NCT02953548 (16) [back to overview]Number of Participants With Any Low or High Hematology Laboratory Parameter Value
NCT02954887 (20) [back to overview]Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score
NCT02954887 (20) [back to overview]Number of Participants Free of Clinical Spasms
NCT02954887 (20) [back to overview]Number of Participants With a Resolution of Hypsarrhythmia
NCT02954887 (20) [back to overview]Number of Participants With Any Clinically Relevant Urinalysis Parameter Value
NCT02954887 (20) [back to overview]Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value
NCT02954887 (20) [back to overview]Number of Participants With Any Low or High Hematology Laboratory Parameter Value
NCT02954887 (20) [back to overview]Number of Responders
NCT02954887 (20) [back to overview]Percentage of Participants Free of Clinical Spasms
NCT02954887 (20) [back to overview]Percentage of Participants With a Resolution of Hypsarrhythmia
NCT02954887 (20) [back to overview]Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)
NCT02954887 (20) [back to overview]Percentage of Responders
NCT02954887 (20) [back to overview]Number of Participants Experiencing Spasms and Seizures by Subtype
NCT02954887 (20) [back to overview]Number of Participants With Clinically Significant Electrocardiogram Findings
NCT02954887 (20) [back to overview]Number of Participants With Clinically Significant Physical Examination Findings
NCT02954887 (20) [back to overview]Number of Participants With Clinically Significant Vital Sign Findings
NCT02954887 (20) [back to overview]Caregiver Global Impression of Change (CGIC)
NCT02954887 (20) [back to overview]Physician Global Impression of Change (PGIC)
NCT02954887 (20) [back to overview]Change From Baseline in Body Weight.
NCT02954887 (20) [back to overview]Change From Baseline in Head Circumference
NCT02954887 (20) [back to overview]Change From Baseline in Height
NCT03102918 (1) [back to overview]Self-report Instruments to Measure Cannabis Use
NCT03248167 (44) [back to overview]Percentage of Very Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Very Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Very Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Very Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Very Heavy Drinking Days
NCT03248167 (44) [back to overview]Number of Participants With No Heavy Drinking Days
NCT03248167 (44) [back to overview]Number of Drinks Per Day
NCT03248167 (44) [back to overview]Number of Drinks Per Day
NCT03248167 (44) [back to overview]Number of Drinks Per Day
NCT03248167 (44) [back to overview]Number of Participants That Are 'Present and Clear'
NCT03248167 (44) [back to overview]Number of Participants That Are 'Present and Clear'
NCT03248167 (44) [back to overview]Number of Participants That Are 'Present and Clear'
NCT03248167 (44) [back to overview]Number of Participants That Are 'Present and Clear'
NCT03248167 (44) [back to overview]Number of Participants That Are 'Present and Clear'
NCT03248167 (44) [back to overview]Number of Participants That Are 'Present and Clear'
NCT03248167 (44) [back to overview]Number of Participants That Are 'Present and Clear'
NCT03248167 (44) [back to overview]Number of Participants With No Heavy Drinking Days
NCT03248167 (44) [back to overview]Number of Participants With No Heavy Drinking Days
NCT03248167 (44) [back to overview]Number of Participants With No Heavy Drinking Days
NCT03248167 (44) [back to overview]Number of Participants With No Heavy Drinking Days
NCT03248167 (44) [back to overview]Number of Participants With No Heavy Drinking Days
NCT03248167 (44) [back to overview]Number of Participants With No Heavy Drinking Days
NCT03248167 (44) [back to overview]PCL-5 Total Score
NCT03248167 (44) [back to overview]PCL-5 Total Score
NCT03248167 (44) [back to overview]PCL-5 Total Score
NCT03248167 (44) [back to overview]Percent Carbohydrate Deficient Transferrin (CDT)
NCT03248167 (44) [back to overview]Percent Carbohydrate Deficient Transferrin (CDT)
NCT03248167 (44) [back to overview]Percent Carbohydrate Deficient Transferrin (CDT)
NCT03248167 (44) [back to overview]Percentage of Days Abstinent
NCT03248167 (44) [back to overview]Percentage of Days Abstinent
NCT03248167 (44) [back to overview]Percentage of Days Abstinent
NCT03248167 (44) [back to overview]Percentage of Days Abstinent
NCT03248167 (44) [back to overview]Percentage of Days Abstinent
NCT03248167 (44) [back to overview]Percentage of Days Abstinent
NCT03248167 (44) [back to overview]Percentage of Days Abstinent
NCT03248167 (44) [back to overview]Percentage of Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Very Heavy Drinking Days
NCT03248167 (44) [back to overview]Percentage of Very Heavy Drinking Days
NCT03252756 (51) [back to overview]Trough CBD Plasma Levels
NCT03252756 (51) [back to overview]Percentage of Heavy Drinking Days
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Penn Alcohol Craving Scale (PACS) Score
NCT03252756 (51) [back to overview]Beck Anxiety Inventory (BAI) Score
NCT03252756 (51) [back to overview]Beck Anxiety Inventory (BAI) Score
NCT03252756 (51) [back to overview]Trough CBD Plasma Levels
NCT03252756 (51) [back to overview]Trough CBD Plasma Levels
NCT03252756 (51) [back to overview]Trough CBD Plasma Levels
NCT03252756 (51) [back to overview]Trough CBD Plasma Levels
NCT03252756 (51) [back to overview]Percent of Heavy Drinking Days
NCT03252756 (51) [back to overview]Penn Alcohol Craving Scale (PACS) Score
NCT03252756 (51) [back to overview]Trough CBD Plasma Levels
NCT03252756 (51) [back to overview]Beck Anxiety Inventory (BAI) Score
NCT03252756 (51) [back to overview]Beck Anxiety Inventory (BAI) Score
NCT03252756 (51) [back to overview]Beck Anxiety Inventory (BAI) Score
NCT03252756 (51) [back to overview]Beck Anxiety Inventory (BAI) Score
NCT03252756 (51) [back to overview]Beck Depression Inventory (BDI) Score
NCT03252756 (51) [back to overview]Beck Depression Inventory (BDI) Score
NCT03252756 (51) [back to overview]Beck Depression Inventory (BDI) Score
NCT03252756 (51) [back to overview]Beck Depression Inventory (BDI) Score
NCT03252756 (51) [back to overview]Beck Depression Inventory (BDI) Score
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Number of Drinks Per Day
NCT03252756 (51) [back to overview]Peak CBD Plasma Levels
NCT03252756 (51) [back to overview]Beck Depression Inventory (BDI) Score
NCT03252756 (51) [back to overview]Peak CBD Plasma Levels
NCT03252756 (51) [back to overview]Peak CBD Plasma Levels
NCT03252756 (51) [back to overview]Peak CBD Plasma Levels
NCT03252756 (51) [back to overview]Peak CBD Plasma Levels
NCT03252756 (51) [back to overview]Peak CBD Plasma Levels
NCT03252756 (51) [back to overview]Peak CBD Plasma Levels
NCT03252756 (51) [back to overview]Penn Alcohol Craving Scale (PACS) Score
NCT03252756 (51) [back to overview]Penn Alcohol Craving Scale (PACS) Score
NCT03252756 (51) [back to overview]Penn Alcohol Craving Scale (PACS) Score
NCT03252756 (51) [back to overview]Penn Alcohol Craving Scale (PACS) Score
NCT03336242 (5) [back to overview]Percent Change From Baseline in Time to Absence Seizure During Hyperventilation Testing on Video-EEG at Visit 5
NCT03336242 (5) [back to overview]Percent Change From Baseline in Absence Seizure Counts Assessed by Video-electroencephalogram (EEG) at Visit 5
NCT03336242 (5) [back to overview]Number of Participants Seizure-Free at Visit 5
NCT03336242 (5) [back to overview]Clinical Global Impression of Improvement (CGI-I) Score at Visit 5
NCT03336242 (5) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT03355300 (1) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT03614663 (8) [back to overview]Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set
NCT03614663 (8) [back to overview]Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Ad Hoc Analysis
NCT03614663 (8) [back to overview]Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Full Analysis Set
NCT03614663 (8) [back to overview]Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Ad Hoc Analysis
NCT03614663 (8) [back to overview]Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Full Analysis Set
NCT03614663 (8) [back to overview]Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Ad Hoc Analysis
NCT03614663 (8) [back to overview]Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Full Analysis Set
NCT03614663 (8) [back to overview]Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Ad Hoc Analysis
NCT03805750 (7) [back to overview]Global Impression of Change
NCT03805750 (7) [back to overview]Number of Participants Reporting Adverse Events Based on Common Terminology Criteria
NCT03805750 (7) [back to overview]Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT03805750 (7) [back to overview]Accelerometry-based Assessment of Tremor Severity
NCT03805750 (7) [back to overview]Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)
NCT03805750 (7) [back to overview]Digital Spirography
NCT03805750 (7) [back to overview]Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities
NCT03848832 (7) [back to overview]Change From Baseline in the Mean RSBQ Total Score at Week 24 for the 5 mg/kg/Day GWP42003-P Dose Level Compared With Placebo
NCT03848832 (7) [back to overview]Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24
NCT03848832 (7) [back to overview]Change From Baseline in the Mean Rett Syndrome Behaviour Questionnaire (RSBQ) Total Score at Week 24 for the 15 mg/kg/Day GWP42003-P Dose Level Compared With Placebo
NCT03848832 (7) [back to overview]Change From Baseline in Mean RSBQ Subscale Scores at Week 24
NCT03848832 (7) [back to overview]Change From Baseline in Mean Clinician Global Impressions - Severity (CGI-S) Score at Week 24
NCT03848832 (7) [back to overview]Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24
NCT03848832 (7) [back to overview]Mean Clinical Global Impressions - Improvement (CGI-I) Score at Week 24
NCT03891264 (2) [back to overview]Changes in Brain Positron Emission Tomography Signal
NCT03891264 (2) [back to overview]Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours).
NCT04192370 (1) [back to overview]Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration
NCT04238754 (7) [back to overview]Safety as Assessed by Number of Adverse Events
NCT04238754 (7) [back to overview]Initial Efficacy of Study Drug as Assessed by Area Under the Curve for the Subjective Opiate Withdrawal Scale (SOWS) Scores
NCT04238754 (7) [back to overview]Change in Withdrawal Scores From Baseline AfterReceiving Placebo
NCT04238754 (7) [back to overview]Acceptability Assessed by Rating of Medication Acceptance on a 5-point Acceptance Rating Scale
NCT04238754 (7) [back to overview]Acceptability Assessed by Number of Participants Who Would Recommend the Medication to a Family Member or Friend
NCT04238754 (7) [back to overview]Number of Participants Whose Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) Levels >3x Upper Limit of Normal
NCT04238754 (7) [back to overview]Acceptability Assessed by Visual Analog Ratings
NCT04252586 (15) [back to overview]Number of Participants With At Least One Post Open Label Extension Baseline Flagged ECG Result
NCT04252586 (15) [back to overview]Number of Participants With Treatment-emergent Clinical Laboratory Parameters From the Baseline at Any Time Post-dose
NCT04252586 (15) [back to overview]Mean Change From Baseline in 9-item Motor Behavioral Assessment (MBA-9) Total Score at End of Treatment
NCT04252586 (15) [back to overview]Mean Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Levels at End of Treatment
NCT04252586 (15) [back to overview]Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs
NCT04252586 (15) [back to overview]Number of Participants With Changes in Tanner Staging at the Baseline and at End of Treatment
NCT04252586 (15) [back to overview]Number of Participants With Clinically Significant Changes in the Vital Sign Values of Pulse Rate From the Baseline at Any Time Post-dose
NCT04252586 (15) [back to overview]Number of Participants With Clinically Significant Percent Change in Body Weight From the Baseline at Any Time Post-dose
NCT04252586 (15) [back to overview]Number of Participants With Potentially Clinically Significant Changes in Vital Sign Values of Blood Pressure From the Baseline at Any Time Post-dose
NCT04252586 (15) [back to overview]Number of Participants With Suicidal Ideation or Behavior at the Baseline and at Any Time Post-dose
NCT04252586 (15) [back to overview]Mean Clinical Global Impressions-Improvement (CGI-I) Continuous Score at End of Treatment
NCT04252586 (15) [back to overview]Mean Change From Baseline in Rett Syndrome Behaviour Questionnaire (RSBQ) Overall Score at End of Treatment
NCT04252586 (15) [back to overview]Number of Participants With Any Changes In Menstruation Cycle at Any Time Post-dose
NCT04252586 (15) [back to overview]Mean Change From Baseline in Children's Sleep Habits Questionnaire (CSHQ) Total Score at End of Treatment
NCT04252586 (15) [back to overview]Mean Clinician Global Impressions - Severity Scale (CGI-S) Continuous Score at End of Treatment
NCT04387617 (4) [back to overview]Total Urinary Symptoms Score
NCT04387617 (4) [back to overview]The Number of Subjects With Adverse Events
NCT04387617 (4) [back to overview]Postoperative Rescue Narcotic Use
NCT04387617 (4) [back to overview]Maximum Pain Intensity Score
NCT04447846 (19) [back to overview]Neuroscore
NCT04447846 (19) [back to overview]Modified House Classification Scores
NCT04447846 (19) [back to overview]Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
NCT04447846 (19) [back to overview]Safety of Epidiolex
NCT04447846 (19) [back to overview]Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55)
NCT04447846 (19) [back to overview]Port-wine Birthmark Score
NCT04447846 (19) [back to overview]Picture Vocabulary Test
NCT04447846 (19) [back to overview]Pediatric Neurological Quality of Life (Neuro-QoL)
NCT04447846 (19) [back to overview]Screen for Child Anxiety Related Disorders (SCARED)
NCT04447846 (19) [back to overview]Pediatric Evaluation of Disability Inventory Computer Adapted Test
NCT04447846 (19) [back to overview]ABILHAND Questionnaire
NCT04447846 (19) [back to overview]Adult Neurological Quality of Life (Neuro-QoL)
NCT04447846 (19) [back to overview]Behavioral Assessment System for Children, Third Edition (BASC-3)
NCT04447846 (19) [back to overview]Erhardt Developmental Prehension Assessment Scores
NCT04447846 (19) [back to overview]List Sorting Working Memory Test
NCT04447846 (19) [back to overview]Migraine Severity
NCT04447846 (19) [back to overview]Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV)
NCT04447846 (19) [back to overview]Social Responsiveness Scale, Second Edition (SRS-2)
NCT04447846 (19) [back to overview]Seizure Frequency
NCT04590495 (14) [back to overview]Change in Baseline VAMS--Physical Sedation
NCT04590495 (14) [back to overview]Change in Baseline VAMS for Mental Sedation
NCT04590495 (14) [back to overview]Change in Baseline TMT Part B
NCT04590495 (14) [back to overview]Change in Baseline TMT Part A
NCT04590495 (14) [back to overview]Driving Performance - Number of Collisions.
NCT04590495 (14) [back to overview]Change in Baseline SRT for Sound #1
NCT04590495 (14) [back to overview]Change in Baseline SSS
NCT04590495 (14) [back to overview]Change in Baseline SRT--sound #2
NCT04590495 (14) [back to overview]Change in Baseline PVT
NCT04590495 (14) [back to overview]Change in Baseline DSST
NCT04590495 (14) [back to overview]Driving Performance - Lateral Position in Lane
NCT04590495 (14) [back to overview]Driving Performance-percent of Time Spent Driving Above Speed Limit
NCT04590495 (14) [back to overview]Driving Performance - Brake Reaction Time
NCT04590495 (14) [back to overview]Driving Performance - Percent of Time Spent Out of Lane
NCT04982029 (6) [back to overview]Attentional Bias
NCT04982029 (6) [back to overview]Stress-Reactivity (Physiological)
NCT04982029 (6) [back to overview]Change in Cue-reactivity
NCT04982029 (6) [back to overview]Stress-reactivity
NCT04982029 (6) [back to overview]Delayed Discount
NCT04982029 (6) [back to overview]Decision Making
NCT05209867 (1) [back to overview]Number of Differentially Expressed Genes

Change in Brief Pain Inventory - Short Form (BPI-SF)

The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). the minimum value is zero and maximum is 10. A higher score represents a poor outcome. (NCT00530764)
Timeframe: Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)

InterventionScore on scale (Mean)
Sativex High Dose Group-1.0
Sativex Medium Dose Group-1.5
Sativex Low Dose Group-1.3
Placebo-1.0

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Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)

The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement. (NCT00530764)
Timeframe: Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)

InterventionScore on scale (Mean)
Sativex High Dose Group0.0
Sativex Medium Dose Group-0.1
Sativex Low Dose Group0.0
Placebo-0.1

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Change in Montgomery Asberg Depression Rating Scale (MADRS)

The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression. (NCT00530764)
Timeframe: Baseline and End of Treatment (Week 5 or premature termination)

InterventionScore on scale (Mean)
Sativex High Dose Group-0.4
Sativex Medium Dose Group-1.0
Sativex Low Dose Group-1.1
Placebo-2.9

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Change in Mean Daily NRS Pain Score (Worst Pain).

"The worst pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your worst pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in worst pain score from baseline." (NCT00530764)
Timeframe: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)

InterventionPoints on scale (Mean)
Sativex High Dose-1.0
Sativex Medium Dose-1.2
Sativex Low Dose-1.6
Placebo-0.9

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Change in Cumulative Average Pain Response Curves

"The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response.~The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer." (NCT00530764)
Timeframe: Baseline to end of treatment (Week 5)

InterventionPercent Change (Median)
Sativex High Dose Group-13
Sativex Medium Dose Group-20
Sativex Low Dose Group-20
Placebo-10

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Change in Mean Daily NRS Pain Score (Average Pain).

"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline." (NCT00530764)
Timeframe: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)

InterventionPoints on scale (Mean)
Sativex High Dose-0.9
Sativex Medium Dose-1.2
Sativex Low Dose-1.6
Placebo-0.8

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Change in Patient Global Impression of Change - PGIC

"A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to cancer since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported." (NCT00530764)
Timeframe: End of Week 5

,,,
InterventionParticipants (Number)
Very much improvedMuch improvedSlightly improvedNo changeSlightly worseMuch worseVery much worse
Placebo9162817110
Sativex High Dose Group6202513612
Sativex Low Dose Group10241913310
Sativex Medium Dose Group6192613502

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Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline

"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening." (NCT00530764)
Timeframe: 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)

InterventionParticipants (Number)
Sativex High Dose Group22
Sativex Medium Dose Group26
Sativex Low Dose Group30
Placebo24

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Change in Sleep Disruption NRS

"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline." (NCT00530764)
Timeframe: 5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)

InterventionPoints on scale (Mean)
Sativex High Dose Group-0.7
Sativex Medium Dose Group-0.9
Sativex Low Dose Group-1.5
Placebo-0.8

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Overall Cognition as Measured on the MATRICS Battery

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) is intended to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. A higher score indicates better cognition (i.e. speed of processing, attention, verbal and non-verbal working memory, visual learning, reasoning, problem solving, and social cognition). The below scores are t-score values, which are normalized scores to the population and comparing the scores to a representative sample. (NCT00588731)
Timeframe: 6 weeks

,
Interventiont-score (Mean)
BaselineEndpoint
Cannabidiol27.826.4
Placebo23.225.4

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Verbal Short Term Memory

Verbal short term memory is measured through the Hopkins Verbal Learning Test. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). However, the data listed below is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample, with a mean of 50. (NCT00588731)
Timeframe: 6 weeks

,
Interventiont-score (Mean)
BaselineEndpoint
Cannabidiol43.743.6
Placebo37.940.8

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The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.03
20:1 GWP42003 : GWP42004-0.16
GWP42003 and Placebo-0.08
GWP42004 and Placebo-0.08
Placebo-0.06

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The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment

Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP42004-0.22
20:1 GWP42003 : GWP42004-0.75
GWP42003 and Placebo0.02
GWP42004 and Placebo-0.29
Placebo-0.37

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The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment

An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionratio (Mean)
1:1 GWP42003 : GWP420040.03
20:1 GWP42003 : GWP420040.04
GWP42003 and Placebo-0.02
GWP42004 and Placebo0.02
Placebo0.01

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The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)

At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionpmol/l (Mean)
1:1 GWP42003 : GWP4200480.9
20:1 GWP42003 : GWP42004-156.6
GWP42003 and Placebo-193.5
GWP42004 and Placebo83.5
Placebo-40.8

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The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])

A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.07
20:1 GWP42003 : GWP420041.09
GWP42003 and Placebo-0.78
GWP42004 and Placebo0.22
Placebo0.42

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The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment

Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionratio (Mean)
1:1 GWP42003 : GWP42004-0.00
20:1 GWP42003 : GWP42004-0.00
GWP42003 and Placebo0.00
GWP42004 and Placebo-0.00
Placebo-0.01

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The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment

Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventioncm (Mean)
1:1 GWP42003 : GWP420040.82
20:1 GWP42003 : GWP42004-0.17
GWP42003 and Placebo0.31
GWP42004 and Placebo-0.39
Placebo-0.86

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The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment

Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP420040.10
20:1 GWP42003 : GWP420040.62
GWP42003 and Placebo0.42
GWP42004 and Placebo-0.11
Placebo0.27

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The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.06
20:1 GWP42003 : GWP42004-0.01
GWP42003 and Placebo0.08
GWP42004 and Placebo-0.02
Placebo-0.08

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The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.16
20:1 GWP42003 : GWP420040.12
GWP42003 and Placebo0.16
GWP42004 and Placebo0.05
Placebo-0.03

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The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment

Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP420040.22
20:1 GWP42003 : GWP420041.11
GWP42003 and Placebo0.01
GWP42004 and Placebo1.08
Placebo-2.44

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The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment

Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP420040.33
20:1 GWP42003 : GWP42004-0.36
GWP42003 and Placebo0.18
GWP42004 and Placebo0.56
Placebo-2.81

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The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment

Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP42004-0.09
20:1 GWP42003 : GWP420040.46
GWP42003 and Placebo0.40
GWP42004 and Placebo-0.52
Placebo-0.88

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Adverse Events as a Measure of Patient Safety

The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented. (NCT01217112)
Timeframe: Day 1 - Day 92

Interventionparticipants (Number)
1:1 GWP42003 : GWP420047
20:1 GWP42003 : GWP420048
GWP42003 and Placebo11
GWP42004 and Placebo11
Placebo13

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The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment

Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP420040.13
20:1 GWP42003 : GWP420041.57
GWP42003 and Placebo0.40
GWP42004 and Placebo0.57
Placebo-3.31

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The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionumol/l (Mean)
1:1 GWP42003 : GWP42004-0.19
20:1 GWP42003 : GWP420040.18
GWP42003 and Placebo0.11
GWP42004 and Placebo0.08
Placebo0.16

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The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.12
20:1 GWP42003 : GWP42004-0.23
GWP42003 and Placebo-0.11
GWP42004 and Placebo-0.11
Placebo-0.16

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The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment

A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionratio (Mean)
1:1 GWP42003 : GWP42004-0.01
20:1 GWP42003 : GWP420040.07
GWP42003 and Placebo0.08
GWP42004 and Placebo0.01
Placebo0.07

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The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionumol/l (Mean)
1:1 GWP42003 : GWP42004-2.86
20:1 GWP42003 : GWP42004-3.51
GWP42003 and Placebo-4.92
GWP42004 and Placebo0.64
Placebo-3.41

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The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment

Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionkg/m^2 (Mean)
1:1 GWP42003 : GWP42004-0.38
20:1 GWP42003 : GWP42004-0.02
GWP42003 and Placebo-0.20
GWP42004 and Placebo-0.21
Placebo-0.50

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The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment

Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP42004-0.23
20:1 GWP42003 : GWP420041.08
GWP42003 and Placebo0.37
GWP42004 and Placebo-0.05
Placebo0.59

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The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment

Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionpercent liver fat (Mean)
1:1 GWP42003 : GWP42004-1.12
20:1 GWP42003 : GWP420040.37
GWP42003 and Placebo-4.73
GWP42004 and Placebo0.77
Placebo-2.95

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The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment

Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP42004-0.02
20:1 GWP42003 : GWP420040.05
GWP42003 and Placebo-0.01
GWP42004 and Placebo0.01
Placebo0.04

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The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment

Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionunits on a scale (Mean)
1:1 GWP42003 : GWP42004-1.19
20:1 GWP42003 : GWP42004-0.84
GWP42003 and Placebo-0.69
GWP42004 and Placebo-0.36
Placebo-0.59

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The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment

The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates 'minimal depression'. A score between 14 and 19 indicates 'mild depression'. A score between 20 and 28 indicates 'moderate depression', and a score between 29 and 63 indicates 'severe depression'. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration. (NCT01217112)
Timeframe: Baseline (Day 1) and the End of Treatment (Day 92)

Interventionunits on a scale (Mean)
1:1 GWP42003 : GWP420040.27
20:1 GWP42003 : GWP420044.91
GWP42003 and Placebo0.85
GWP42004 and Placebo0.58
Placebo-0.08

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The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment

Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionkg (Mean)
1:1 GWP42003 : GWP42004-1.05
20:1 GWP42003 : GWP42004-0.10
GWP42003 and Placebo-0.46
GWP42004 and Placebo-0.66
Placebo-1.64

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The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionnmol/l (Mean)
1:1 GWP42003 : GWP420040.02
20:1 GWP42003 : GWP420040.09
GWP42003 and Placebo-0.03
GWP42004 and Placebo0.12
Placebo0.09

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The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.23
20:1 GWP42003 : GWP420040.44
GWP42003 and Placebo0.41
GWP42004 and Placebo-0.76
Placebo0.38

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The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionpmol/l (Mean)
1:1 GWP42003 : GWP4200412.01
20:1 GWP42003 : GWP42004-6.06
GWP42003 and Placebo13.44
GWP42004 and Placebo45.62
Placebo2.79

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The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionumol/l (Mean)
1:1 GWP42003 : GWP420042.8
20:1 GWP42003 : GWP4200414.5
GWP42003 and Placebo-2.6
GWP42004 and Placebo1.1
Placebo9.5

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The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionpercent (Mean)
1:1 GWP42003 : GWP420040.14
20:1 GWP42003 : GWP420040.16
GWP42003 and Placebo0.08
GWP42004 and Placebo-0.03
Placebo0.31

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The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment

Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionpercent sensitivity (Mean)
1:1 GWP42003 : GWP42004-5.26
20:1 GWP42003 : GWP42004-1.71
GWP42003 and Placebo1.71
GWP42004 and Placebo6.47
Placebo-4.07

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The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment

An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionratio (Mean)
1:1 GWP42003 : GWP42004-0.01
20:1 GWP42003 : GWP420040.00
GWP42003 and Placebo-0.02
GWP42004 and Placebo0.03
Placebo0.01

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The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.04
20:1 GWP42003 : GWP42004-0.06
GWP42003 and Placebo-0.11
GWP42004 and Placebo-0.01
Placebo-0.02

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The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment

Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventioncm (Mean)
1:1 GWP42003 : GWP420041.12
20:1 GWP42003 : GWP420040.07
GWP42003 and Placebo0.38
GWP42004 and Placebo-0.19
Placebo-0.20

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The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment

Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

InterventionIR score (Mean)
1:1 GWP42003 : GWP420040.19
20:1 GWP42003 : GWP42004-0.19
GWP42003 and Placebo0.35
GWP42004 and Placebo0.64
Placebo0.09

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The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment

Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionpercent beta function (Mean)
1:1 GWP42003 : GWP420048.13
20:1 GWP42003 : GWP42004-7.64
GWP42003 and Placebo-1.31
GWP42004 and Placebo36.59
Placebo-2.41

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The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment

Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP420040.6
20:1 GWP42003 : GWP420040.4
GWP42003 and Placebo0.2
GWP42004 and Placebo0.8
Placebo-2.4

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The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment

Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionlitres (Mean)
1:1 GWP42003 : GWP42004-0.3
20:1 GWP42003 : GWP420040.5
GWP42003 and Placebo-0.0
GWP42004 and Placebo0.1
Placebo0.3

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The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.47
20:1 GWP42003 : GWP420040.14
GWP42003 and Placebo0.09
GWP42004 and Placebo0.09
Placebo-0.12

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The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.53
20:1 GWP42003 : GWP42004-0.27
GWP42003 and Placebo-0.22
GWP42004 and Placebo-0.13
Placebo-0.09

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The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP420040.06
20:1 GWP42003 : GWP42004-0.03
GWP42003 and Placebo-0.05
GWP42004 and Placebo-0.02
Placebo0.01

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The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP42004-0.29
20:1 GWP42003 : GWP42004-0.13
GWP42003 and Placebo-0.11
GWP42004 and Placebo-0.02
Placebo0.07

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The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment

At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement. (NCT01217112)
Timeframe: Baseline (Day 1) and End of treatment (Day 92)

Interventionmmol/l (Mean)
1:1 GWP42003 : GWP420040.00
20:1 GWP42003 : GWP420040.04
GWP42003 and Placebo-0.04
GWP42004 and Placebo0.00
Placebo0.02

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Change From Baseline To The EOT In Mean Serum Triglyceride Levels

A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition. (NCT01284634)
Timeframe: Baseline to EOT (Day 57) or ET

Interventionmmol/l (Mean)
GWP42003 200 mg/Day Dose-0.40
GWP42003 400 mg/Day Dose-0.29
GWP42003 800 mg/Day Dose-0.50
Placebo-0.28

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Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels

Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition. (NCT01284634)
Timeframe: Baseline to EOT (Day 57) or Early Termination (ET)

Interventionpercentage change (Mean)
GWP42003 200 mg/Day Dose-0.68
GWP42003 400 mg/Day Dose-0.28
GWP42003 800 mg/Day Dose0.65
Placebo6.36

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Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio

A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition. (NCT01284634)
Timeframe: Baseline to EOT (Day 57) or ET

Interventionchange in ratio (Mean)
GWP42003 200 mg/Day Dose-0.02
GWP42003 400 mg/Day Dose-0.00
GWP42003 800 mg/Day Dose0.03
Placebo0.01

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Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels

A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition. (NCT01284634)
Timeframe: Baseline to EOT (Day 57) or ET

Interventionmmol/l (Mean)
GWP42003 200 mg/Day Dose0.07
GWP42003 400 mg/Day Dose0.08
GWP42003 800 mg/Day Dose0.06
Placebo-0.14

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Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels

A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition. (NCT01284634)
Timeframe: Baseline to EOT (Day 57) or ET

Interventionmillimole (mmol)/l (Mean)
GWP42003 200 mg/Day Dose0.07
GWP42003 400 mg/Day Dose0.03
GWP42003 800 mg/Day Dose-0.14
Placebo-0.62

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Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels

A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition. (NCT01284634)
Timeframe: Baseline to EOT (Day 57) or ET

Interventionmmol/l (Mean)
GWP42003 200 mg/Day Dose0.11
GWP42003 400 mg/Day Dose0.08
GWP42003 800 mg/Day Dose0.00
Placebo-0.34

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Number Of Participants Who Reported An Improvement In The Subject Global Impression Of Change (SGIC) Questionnaire At EOT

"Participants were asked to answer the following question by using a 7-point scale (1 = very much better to 7 = very much worse): Please assess the change in your ulcerative colitis symptoms since immediately before receiving the first dose of study treatment. Improvement was considered as very much better, much better, or minimally better." (NCT01562314)
Timeframe: Visit 4 (Day 43) to EOT (10 weeks) or ET

,
InterventionParticipants (Count of Participants)
Visit 4 (Day 43)Final Visit
GWP420031523
Placebo1817

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Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency NRS - PP Analysis

Participants were required to record their stool frequency during the baseline and treatment periods in a daily diary. Participants graded stool frequency with a 4-point NRS as follows: 0 = Normal number of stools; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal. For analysis, the baseline value was defined as the mean stool frequency score of the last 7 available days of the baseline period; the EOT value was defined as the mean stool frequency score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (last 7 days) or ET

,
Interventionunits on a scale (Mean)
BaselineLast 7 DaysChange From Baseline
GWP420031.370.73-0.64
Placebo1.811.36-0.45

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Number Of Participants Who Reported An Improvement In The SGIC Questionnaire At EOT - PP Analysis

"Participants were asked to answer the following question by using a 7-point scale (1 = very much better to 7 = very much worse): Please assess the change in your ulcerative colitis symptoms since immediately before receiving the first dose of study treatment. Improvement was considered as very much better, much better, or minimally better." (NCT01562314)
Timeframe: Visit 4 (Day 43) to EOT (10 weeks) or ET

,
InterventionParticipants (Count of Participants)
Visit 4 (Day 43)Final Visit
GWP420031416
Placebo1816

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Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency Numerical Rating Scale (NRS)

Participants were required to record their stool frequency during the baseline and treatment periods in a daily diary. Participants graded stool frequency with a 4-point NRS as follows: 0 = Normal number of stools; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal. For analysis, the baseline value was defined as the mean stool frequency score of the last 7 available days of the baseline period; the EOT value was defined as the mean stool frequency score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (last 7 days) or ET

,
Interventionunits on a scale (Mean)
BaselineLast 7 DaysChange From Baseline
GWP420031.501.05-0.43
Placebo1.891.46-0.43

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Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT

The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores, each of which is assessed using a 0 to 3 scale. Sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); Physician's Global Assessment of Illness Severity (PGAS): 0 = none, 1 = mild, 2 = moderate, and 3 = severe. (NCT01562314)
Timeframe: Baseline to End of Treatment (EOT) (10 weeks) or Early Termination (ET)

InterventionParticipants (Count of Participants)
GWP420038
Placebo8

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Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT - PP Analysis

The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores, each of which is assessed using a 0 to 3 scale. Sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

InterventionParticipants (Count of Participants)
GWP420037
Placebo8

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Change From Baseline To EOT In Levels Of Fecal Calprotectin

Fecal calprotectin is a marker of inflammation. Standard methods were used to measure the levels of calprotectin in fecal samples collected at the end of baseline and treatment periods. A negative change from Baseline indicates that levels of fecal calprotectin decreased. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionmicrogram calprotectin/gram feces (ug/g) (Mean)
BaselineFinal VisitChange from Baseline
GWP42003490.6397.3-91.6
Placebo462.3428.0-51.3

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Change From Baseline To EOT In Levels Of Fecal Calprotectin- PP Analysis

Fecal calprotectin is a marker of inflammation. Standard methods were used to measure the levels of calprotectin in fecal samples collected at the end of baseline and treatment periods. A negative change from Baseline indicates that levels of fecal calprotectin decreased. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionug/g (Mean)
BaselineFinal VisitChange From Baseline
GWP42003527.9355.9-155.9
Placebo440.3408.9-51.9

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Change From Baseline To EOT In The IBDQ Total Score - PP Analysis

The IBDQ is a validated and reliable tool to measure health-related quality of life in adult participants with IBD. Each of the 32 questions falls into 1 of 4 domains (bowel symptoms, systemic symptoms, emotional status and social function). The 32 questions each have 7 possible responses. Each response is assigned a score ranging from 1 to 7, indicating the severity (1 being least favorable and 7 being the most favorable). Individual question scores were summed to give the IBDQ total score (range: 32 to 224 points). A positive change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionunits on a scale (Mean)
BaselineFinal VisitChange From Baseline
GWP42003134.0172.839.3
Placebo134.0150.515.4

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Change From Baseline To EOT In The Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

The IBDQ is a validated and reliable tool to measure health-related quality of life in adult participants with inflammatory bowel disease (IBD). Each of the 32 questions falls into 1 of 4 domains (bowel symptoms, systemic symptoms, emotional status and social function). The 32 questions each have 7 possible responses. Each response is assigned a score ranging from 1 to 7, indicating the severity (1 being least favorable and 7 being the most favorable). Individual question scores were summed to give the IBDQ total score (range: 32 to 224 points). A positive change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionunits on a scale (Mean)
BaselineFinal VisitChange From Baseline
GWP42003138.5164.224.6
Placebo129.1146.816.7

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Change From Baseline To EOT In The Mayo Partial Score

The Mayo score is an assessment of ulcerative colitis activity. The Mayo partial score does not include the endoscopy findings sub-score and ranges from 0 to 9 points with higher scores indicating more severe disease. The partial score is made up of 3 sub-scores (assessed by using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; PGAS: 0 = none, 1 = mild, 2 = moderate and 3 = severe. A negative change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionunits on a scale (Mean)
BaselineFinal VisitChange From Baseline
GWP420034.42.3-2.0
Placebo5.13.8-1.2

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Change From Baseline To EOT In The Mayo Partial Score - PP Analysis Set

The Mayo score is an assessment of ulcerative colitis activity. The Mayo partial score does not include the endoscopy findings sub-score and ranges from 0 to 9 points with higher scores indicating more severe disease. The partial score is made up of 3 sub-scores (assessed by using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionunits on a scale (Mean)
BaselineFinal VisitChange From Baseline
GWP420034.11.7-2.4
Placebo4.93.7-1.2

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Change From Baseline To EOT In The Mayo Total Score

The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores (assessed using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate and 3 = severe. A negative change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionunits on a scale (Mean)
BaselineFinal VisitChange From Baseline
GWP420036.33.0-3.0
Placebo7.04.9-1.8

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Change From Baseline To EOT In The Mayo Total Score - PP Analysis

The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores (assessed using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionunits on a scale (Mean)
BaselineFinal VisitChange From Baseline
GWP420036.02.8-3.2
Placebo6.84.7-1.9

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Change From Baseline To EOT In The PGAS Score

The PGAS required the physician to assess participants' disease severity on a 4-point scale (0=normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease). A negative change from Baseline indicates that symptoms decreased. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionunits on a scale (Mean)
BaselineFinal VisitChange From Baseline
GWP420031.71.0-0.8
Placebo1.81.4-0.4

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Change From Baseline To EOT In The PGAS Score - PP Analysis

The PGAS required the physician to assess participants' disease severity on a 4-point scale (0=normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease). A negative change from Baseline indicates that symptoms decreased. (NCT01562314)
Timeframe: Baseline to EOT (10 weeks) or ET

,
Interventionunits on a scale (Mean)
BaselineFinal VisitChange From Baseline
GWP420031.80.8-0.9
Placebo1.81.4-0.4

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Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS

Participants were required to record their rectal bleeding during the baseline and treatment periods in a daily diary. Participants graded rectal bleeding with a 4-point NRS as follows: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes. For analysis, the baseline value was defined as the mean rectal bleeding score of the last 7 available days of the baseline period; the EOT value was defined as the mean rectal bleeding score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (last 7 days) or ET

,
Interventionunits on a scale (Mean)
BaselineLast 7 DaysChange From Baseline
GWP420030.960.48-0.44
Placebo1.190.84-0.35

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Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS - PP Analysis

Participants were required to record their rectal bleeding during the baseline and treatment periods in a daily diary. Participants graded rectal bleeding with a 4-point NRS as follows: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes. For analysis, the baseline value was defined as the mean rectal bleeding score of the last 7 available days of the baseline period; the EOT value was defined as the mean rectal bleeding score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved. (NCT01562314)
Timeframe: Baseline to EOT (last 7 days) or ET

,
Interventionunits on a scale (Mean)
BaselineLast 7 DaysChange From Baseline
GWP420030.820.24-0.58
Placebo1.160.80-0.35

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Visual Analog Scale for Anxiety (VASA)

"Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale for anxiety (VASA). Scale: 0 (not at all anxious) - 10 (extremely anxious).~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV." (NCT01605539)
Timeframe: Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

,
Interventionunits on a scale (Mean)
Test 1: Baseline to Post Drug CueTest 1: Baseline to Post Neutral CueTest 2: Baseline to Post Drug CueTest 2: Baseline to Post Neutral CueTest 4: Baseline to Post Drug CueTest 4: Baseline to Post Neutral Cue
CBD Group0.00-0.33-0.50-0.500.00-0.33
Control2.000.331.33-0.670.00-0.67

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The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data

"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Positive Affect Assessment (PAS): 10 (minimum) - 50 (maximum). Higher score reflects stronger positive affect.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV." (NCT01605539)
Timeframe: Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

,
Interventionunits on a scale (Mean)
Test 1: Baseline to Post Drug CueTest 1: Baseline to Post-Neutral CueTest 2: Baseline to Post Drug CueTest 2: Baseline to Post Neutral CueTest 4: Baseline to Post Drug CueTest 4: Baseline to Post Neutral Cue
CBD Group-0.50-1.83-1.000.17-1.330.67
Control1.331.33-4.00-4.67-3.502.50

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The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data

"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Negative Affect Assessment (NAS): 10 (minimum) - 50 (maximum). Higher score reflects stronger negative affect.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV." (NCT01605539)
Timeframe: Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

,
Interventionunits on a scale (Mean)
Test 1: Baseline to Post Drug CueTest 1: Baseline to Post Neutral CueTest 2: Baseline to Post Drug CueTest 2: Baseline to Post Neutral CueTest 4: Baseline to Post Drug CueTest 4: Baseline to Post Neutral Cue
CBD Group0.50-1.500.000.170.33-0.67
Control4.001.334.00-0.33-1.50-7.00

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Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)

"Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings).~** The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session." (NCT01605539)
Timeframe: Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV

,
Interventionunits on a scale (Mean)
Test 1: Change from pre-dose to 6 hrs post-doseTest 2: Change from pre-dose to 6 hrs post-doseChange from Test 1 (pre-dose) to Test 4 (pre-cue)
CBD Group-0.33-6.17-16.33
Control-3.67-5.33-4.33

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Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)

"The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving).~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test" (NCT01605539)
Timeframe: VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

,
Interventionunits on a scale (Mean)
Test 1: Baseline to Post Drug CueTest 1: Baseline to Post Neutral CueTest 2: Baseline to Post Drug CueTest 2: Baseline to Post Neutral CueTest 4: Baseline to Post Drug CueTest 4: Baseline to Post Neutral Cue
CBD Group0.83-0.170.67-0.670.33-0.50
Control2.67-0.330.670-0.330.331.00

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Vital Signs - Blood Pressure

"Blood pressure (mmHg) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Blood pressure will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV." (NCT01605539)
Timeframe: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

,
InterventionmmHg (Mean)
Systolic BP change (mmHG): test 1, baseline to PCSystolic BP change (mmHG): test 1, baseline to PNSystolic BP change (mmHG): Test 2, baseline to PCSystolic BP change (mmHG): test 2, baseline to PNSystolic BP change (mmHG): Test 4, baseline to PCSystolic BP change (mmHG): test 4, baseline to PNDiastolic BP change (mmHG): test 1, baseline to PCDiastolic BP change (mmHG): test 1 baseline to PNDiastolic BP change (mmHG): test 2 baseline to PCDiastolic BP change (mmHG): test 2 baseline to PNDiastolic BP change (mmHG): test 4 baseline to PCDiastolic BP change (mmHG): test 4 baseline to PN
CBD Group4.50.178.54.83-6.339.675.331.51.830.830.67-1.33
Control8.33-0.33-8.675.001.00-11.676.33-0.33-43.67-0.33-3.67

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Vital Signs - Heart Rate

"Heart rate (in beats/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Heart rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV." (NCT01605539)
Timeframe: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

,
Interventionbeats per minute (Mean)
Heart rate change (bpm): test 1 baseline to PCHeart rate change (bpm): test 1 baseline to PNHeart rate change (bpm): test 2 baseline to PCHeart rate change (bpm): test 2 baseline to PNHeart rate change (bpm): test 4 baseline to PCHeart rate change (bpm): test 4 baseline to PN
CBD Group4.002.5-6.5-3.33-3.33-2.17
Control-2.33-6-8-1.330-1.67

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Vital Signs - Respiratory Rate

"Respiratory rate (in breaths/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Respiratory rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV." (NCT01605539)
Timeframe: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

,
Interventionbreaths per minute (Mean)
Respiratory rate (bpm): test 1 baseline to PCRespiratory rate (bpm): test 1 baseline to PNRespiratory rate (bpm): test 2 baseline to PCRespiratory rate (bpm): test 2 baseline to PNRespiratory rate (bpm): test 4 baseline to PCRespiratory rate (bpm): test 4 baseline to PN
CBD Group000-1-0.670.33
Control00-0.670-0.67-0.67

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Vital Signs - Temperature

"Temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Temperature will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV." (NCT01605539)
Timeframe: Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)

,
Interventiondegrees F (Mean)
Temperature change (F): test 1 baseline to PCTemperature change (F): test 1 baseline to PNTemperature change (F): test 2 baseline to PCTemperature change (F): test 2 baseline to PNTemperature change (F): test 4 baseline to PCTemperature change (F): test 4 baseline to PN
CBD Group-3.350.030.050.020.18-0.17
Control0.030.430.000.30.13

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Withdrawal

"Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported.~Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal." (NCT01747850)
Timeframe: six months

InterventionTotal Withdrawal score (Mean)
Sativex Withdrawal5.0
Placebo Withdrawal5.1
Pilot Withdrawal2.7

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Cannabis Use (in Days)

The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report) (NCT01747850)
Timeframe: six months

Interventionpercentage of days (Mean)
Sativex % Days Use of Cannabis42.9
Placebo % Days Use of Cannabis47.1
Pilot % Days Use of Cannabis48.3

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Tolerability

Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs. (NCT01747850)
Timeframe: six months

InterventionParticipants (Count of Participants)
Sativex # of Participants That Withdrew Due SAE0
Placebo # of Participants That Withdrew Due SAE0
Pilot Study # of Participants That Withdrew Due SAE0

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Cannabis Use (Grams)

Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed (NCT01747850)
Timeframe: six months

Interventiongrams of cannabis (Mean)
Sativex Cannabis Use (g)2.3
Placebo Cannabis Use (g)3.5
Pilot Cannabis Use (g)1.6

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Cannabis Craving

"Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported.~Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana." (NCT01747850)
Timeframe: six months

InterventionTotal Craving Scores (Mean)
Sativex Craving8.2
Placebo Craving9.6
Pilot Craving9.5

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Cannabis Withdrawal

Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions). (NCT01748799)
Timeframe: 8 weeks

,,,,,,,
Interventionunits on a scale (Mean)
Cannabis Withdrawal Scale (CWS)Cannabis Withdrawal Checklist (CWC) Total
Fixed Dose Placebo17.97.4
Fixed Dose Sativex10.33.6
Self-titrated Placebo13.75.9
Self-titrated Sativex9.84.0
Smoke as Usual FP8.63.7
Smoke as Usual FS7.92.6
Smoke as Usual StP7.53.0
Smoke as Usual StS6.62.3

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Feasibility

Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year. (NCT01748799)
Timeframe: 12 months

Interventionparticipants (Number)
Sequence 11
Sequence 21
Sequence 31
Sequence 42
Sequence 51
Sequence 61
Sequence 71
Sequence 81

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Tolerability of Sativex in Persons That Are Cannabis Dependent

To assess what number of participants might withdrew due non-tolerability of Sativex (NCT01748799)
Timeframe: 8 weeks

Interventionparticipants (Number)
Sequence 10
Sequence 20
Sequence 30
Sequence 40
Sequence 50
Sequence 60
Sequence 70
Sequence 80

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Plasma Concentration of CBD

Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD. (NCT01844687)
Timeframe: 6 hours

Interventionng/mL (Mean)
baseline60 minutes after dosing120 minutes after dosing180 minutes after dosing240 minutes after dosing300 minutes after dosing360 minutes after dosing
Plasma CBD Concentrations011.0638.8877.9577.9050.4564.04

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Mood Scale - Subscale 'Feeling High'

"Participants rated how much they felt having a high feeling from smoked marijuana using a visual analog scale 1-100 mm, 1 (Not at all) - 100 (extremely)." (NCT01844687)
Timeframe: two hours before and after marijuana cigarette smoking

,,,,,,,
Interventionunits on a scale VAS 1-100 mm (Mean)
-120 mins-30 mins30 mins after MJ60 mins after MJ90 mins after MJ120 mins after MJ
Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)4.354.3946.6536.5524.2917.19
Active MJ With 200 mg CBD2.483.1345.9038.0326.8717.13
Active MJ With 400 mg CBD0.394.3243.3232.6815.3911.65
Active MJ With 800 mg CBD6.552.1036.6543.1024.9016.84
Inactive MJ With 0 mg CBD0.421.9410.527.234.712.35
Inactive MJ With 200 mg CBD0.322.0017.848.848.394.48
Inactive MJ With 400 mg CBD3.351.006.234.032.100.68
Inactive MJ With 800 mg CBD1.062.8713.946.942.484.26

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Marijuana Rating Form - Strength

Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most (NCT01844687)
Timeframe: 15 - 120 minutes after marijuana cigarette smoking

,,,,,,,
Interventionunits on a scale (Mean)
15 minutes after smoking30 minutes after smoking60 minutes after smoking90 minutes after smoking120 minutes after smoking
Active MJ With 0 mg CBD45.6855.6545.8427.1918.68
Active MJ With 200 mg CBD58.0355.0344.6834.9722.87
Active MJ With 400 mg CBD51.4848.6739.7128.4519.42
Active MJ With 800 mg CBD51.8757.6145.4232.5228.45
Inactive MJ With 0 mg CBD20.3214.429.037.037.55
Inactive MJ With 200 mg CBD20.8318.9413.0611.198.35
Inactive MJ With 400 mg CBD18.5211.776.396.484.65
Inactive MJ With 800 mg CBD16.8714.8311.657.947.19

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Number of Optional Puffs of MJ Cigarette Taken

Mean number of puffs taken by those participants who chose to take additional puffs. (NCT01844687)
Timeframe: 150 to 160 minutes after first marijuana cigarette was smoked earlier in the day

Interventionnumber of puffs taken per participant (Mean)
Active MJ With 0 mg CBD1.68
Active MJ With 200 mg CBD1.71
Active MJ With 400 mg CBD1.58
Active MJ With 800 mg CBD1.55
Inactive MJ With 0 mg CBD0.94
Inactive MJ With 200 mg CBD1.00
Inactive MJ With 400 mg CBD1.00
Inactive MJ With 800 mg CBD0.97

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Marijuana Rating Form - Like

Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most (NCT01844687)
Timeframe: 15 - 120 minutes after marijuana cigarette smoking

,,,,,,,
Interventionunits on a scale (Mean)
15 minutes after smoking30 minutes after smoking60 minutes after smoking90 minutes after smoking120 minutes after smoking
Active MJ With 0 mg CBD55.3257.1052.5549.5841.29
Active MJ With 200 mg CBD65.8757.7757.9051.6846.00
Active MJ With 400 mg CBD61.4258.7753.0347.8442.55
Active MJ With 800 mg CBD61.9460.5853.2650.1346.81
Inactive MJ With 0 mg CBD25.6520.1614.3715.9714.84
Inactive MJ With 200 mg CBD25.0324.5821.3218.5216.81
Inactive MJ With 400 mg CBD22.8117.9716.0315.0614.00
Inactive MJ With 800 mg CBD22.4818.1723.5217.4216.48

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Optional Additional Puffs of MJ Cigarette

Participants were allowed to choose to take or reject additional puffs of the same type of MJ cigarette they smoked earlier in the day. Counts of participants choosing to take additional puffs are reported. (NCT01844687)
Timeframe: 150 to 250 minutes after first marijuana cigarette was smoked earlier in the day

InterventionParticipants (Count of Participants)
Active MJ With 0 mg CBD19
Active MJ With 200 mg CBD19
Active MJ With 400 mg CBD18
Active MJ With 800 mg CBD18
Inactive MJ With 0 mg CBD10
Inactive MJ With 200 mg CBD11
Inactive MJ With 400 mg CBD11
Inactive MJ With 800 mg CBD10

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Heart Rate

Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis. (NCT01844687)
Timeframe: 120 minutes before and 150 minutes after marijuana cigarette smoking

,,,,,,,
Interventionbeats per minute (Mean)
120 minutes before smoking60 minutes before smoking30 minutes before smoking5 minutes before smoking15 minutes after smoking30 minutes after smoking60 minutes after smoking90 minutes after smoking120 minutes after smoking150 minutes after smoking
Active MJ With 0 mg CBD66.4568.0665.7760.9478.9771.8764.0365.0069.7767.45
Active MJ With 200 mg CBD69.5868.2366.8464.4879.2375.4568.4269.1373.0371.39
Active MJ With 400 mg CBD69.9067.8765.4264.5580.7473.0367.9466.1672.9071.03
Active MJ With 800 mg CBD66.2367.0666.3565.0678.6875.9068.4868.8770.2968.68
Inactive MJ With 0 mg CBD65.1364.9764.9062.5563.8161.3560.0364.0667.3566.58
Inactive MJ With 200 mg CBD67.6568.3267.4265.5864.1662.9462.0363.9769.6867.71
Inactive MJ With 400 mg CBD65.6865.5567.5563.1063.9762.5261.2961.8767.3566.50
Inactive MJ With 800 mg CBD67.8466.0666.7465.0064.5564.1363.0665.8168.8768.70

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Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)

The CGI-S was a 7-point scale that required the clinician to rate the severity of a participant's illness at the time of assessment, relative to the clinician's past experience of participants who had the same diagnosis. Considering total clinical experience, participants were assessed on severity of mental illness at the time of rating on the following scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Lower scores equated to milder severity of symptoms, that is, closer to psychologically normal. (NCT02006628)
Timeframe: Day 1 through Day 43

,
Interventionscore on a scale (Mean)
Baseline scoreEnd of Treatment scoreChange from Baseline
GWP42003 1000 mg/Day4.03.5-0.5
Placebo4.03.8-0.3

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Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)

The SANS assessed 5 symptom complexes to obtain clinical ratings of negative symptoms in participants with schizophrenia or related psychotic disorder. Symptom complexes were affective blunting, alogia (impoverished thinking), avolition/apathy, anhedonia/asociality, and disturbance of attention. Assessments were conducted on a 6-point scale (0 = not at all; 5 = severe). The total score could range from 0 to 125 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal. (NCT02006628)
Timeframe: Day 1 through Day 43

,
Interventionscore on a scale (Mean)
Baseline scoreEnd of Treatment scoreChange from Baseline
GWP42003 1000 mg/Day52.843.6-9.1
Placebo55.348.4-6.3

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Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)

The CGI-I was a 7-point scale that required the clinician to assess how much a participant's illness had improved or worsened relative the first assessment at the beginning of the intervention. This was rated on the following scale: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Lower scores equated to improvement of symptoms. (NCT02006628)
Timeframe: Day 8 through Day 43

,
Interventionscore on a scale (Mean)
Day 8 scoreEnd of Treatment score
GWP42003 1000 mg/Day3.62.9
Placebo3.83.4

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Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score

The PANSS was a 30-item medical scale completed by a trained rater that assessed the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. The PANSS Total score was derived from the sum of the 30 items, which were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total score is the summed total for each of the PANSS positive symptom ('P'), negative symptom ('N'), general psychopathology symptom ('G') scores and could range from 30 to 210 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal. (NCT02006628)
Timeframe: Day 1 through Day 43

,
Interventionscore on a scale (Mean)
Baseline scoreEnd of Treatment scoreChange from baseline
GWP42003 1000 mg/Day79.368.1-11.2
Placebo80.671.9-8.8

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Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score

The BACS was an instrument used to assess the aspects of cognition found to be most impaired and most strongly correlated with outcome in participants with schizophrenia or related psychotic disorder. The BACS consisted of 6 domains: verbal memory (score range 0 to 75), working memory (score range 0 to 28), motor speed (score range 0 to 100), verbal fluency (score > 0, with no set maximum value), attention and speed of information processing (score range 0 to 110), and executive functions (score range 0 to 22). A score was obtained for each of the 6 domains. A composite summary score was then calculated as the arithmetic mean of the unweighted scores from the 6 domains. While there was not an upper limit on the composite score, overall, an increase in score was indicative of an improvement in cognition. (NCT02006628)
Timeframe: Day 1 through Day 43

,
Interventionscore on a scale (Mean)
Baseline scoreEnd of Treatment scoreChange from Baseline
GWP42003 1000 mg/Day32.2135.733.48
Placebo32.9135.052.14

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Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score

The PANSS 'G' scale measured the severity of general psychopathology symptoms, including somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgement and insight, disturbance of violation, poor impulse control, preoccupation, and active social avoidance. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'G' score could range from 16 to 112 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal. (NCT02006628)
Timeframe: Day 1 through Day 43

,
Interventionscore on a scale (Mean)
Baseline scoreEnd of Treatment scoreChange from Baseline
GWP42003 1000 mg/Day38.733.4-5.3
Placebo39.735.6-4.1

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Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score

The PANSS 'N' scale measured the severity of negative symptoms, including blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'N' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal. (NCT02006628)
Timeframe: Day 1 through Day 43

,
Interventionscore on a scale (Mean)
Baseline scoreEnd of Treatment scoreChange from Baseline
GWP42003 1000 mg/Day22.619.9-2.7
Placebo23.420.5-2.9

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Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score

The PANSS 'P' scale measured the severity of positive symptoms, including delusions, conceptual disorganization, hallucinations, hyperactivity, grandiosity, suspiciousness/persecution, and hostility. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'P' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal. (NCT02006628)
Timeframe: Day 1 through Day 43

,
Interventionscore on a scale (Mean)
Baseline scoreEnd of Treatment scoreChange from Baseline
GWP42003 1000 mg/Day18.014.8-3.2
Placebo17.515.7-1.7

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Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22

AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation. (NCT02091206)
Timeframe: Predose and 2-6 hours postdose on Days 1 and 22

,,
Interventionhours * nanograms/mL (Geometric Mean)
Day 1 CBDDay 22 CBDDay 1 6-OH-CBDDay 22 6-OH-CBDDay 1 7-OH-CBDDay 22 7-OH-CBDDay 1 7-COOH-CBDDay 22 7-COOH-CBD
GWP42003-P 10 mg/kg/Day Dose66.35721.82.7926.318.42441259220
GWP42003-P 20 mg/kg/Day Dose73.69962.65.1658.630.250819515500
GWP42003-P 5 mg/kg/Day Dose70.61240.83.279.3321.91312974190

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Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)

"A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented.~A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module." (NCT02091206)
Timeframe: Baseline (Day 1) through Safety follow-up visit (Day 60)

InterventionParticipants (Count of Participants)
GWP42003-P 5 mg/kg/Day Dose2
GWP42003-P 10 mg/kg/Day Dose1
GWP42003-P 20 mg/kg/Day Dose0
Placebo1

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Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations

Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22). (NCT02091206)
Timeframe: Predose on Days 1 and 22

,,,
Interventionpercent change (Number)
% change in CLB% change in N-CLB
GWP42003-P 10 mg/kg/Day Dose18.0170.7
GWP42003-P 20 mg/kg/Day Dose29.6228.9
GWP42003-P 5 mg/kg/Day Dose-1.2258.7
Placebo15.1-5.6

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Number Of Participants With Inpatient Hospitalizations Due To Epilepsy

Inpatient hospitalizations due to epilepsy were recorded by the participant or caregiver and through the serious adverse events (SAE) reporting process. (NCT02091375)
Timeframe: Baseline to Safety Follow-up (Day 137)

,
Interventionparticipants (Number)
Caregiver/participant-reportedInvestigator-reported (serious TEAE)
GWP42003-P 20 mg/kg/Day Dose52
Placebo11

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Change From Baseline In Sleep Disruption 0 To 10 Numerical Rating Scale (0 to 10 NRS) Score

The sleep disruption 0 to 10 NRS questionnaire was completed by the participant's caregiver. The caregiver was asked 'On a scale of '0 to 10', please indicate the number that best describes your child's sleep disruption in the last week.' The markers ranged from 0 = 'slept extremely well' to 10 = 'unable to sleep at all'. The change from baseline in the sleep disruption 0 to 10 numerical rating scale score was analyzed using an analysis of covariance (ANCOVA) model with baseline and age group (2 to 5 years, 6 to 12 years and 13 to 18 years) as covariates and treatment group as a fixed factor. A negative change from baseline represents an improvement in sleep. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed. (NCT02091375)
Timeframe: Baseline to Last Visit (Day 99) or ET

Interventionunits on a scale (Least Squares Mean)
GWP42003-P 20 mg/kg/Day Dose-0.7
Placebo-0.3

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Change From Baseline In Quality Of Life In Childhood Epilepsy (QOLCE) Score

The QOLCE questionnaire was completed by the parent or caregiver of participants aged 4 years and above. The change from baseline in the overall quality of life score was analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6 to 12 years and 13 to 18 years) as covariates and treatment group as a fixed factor. Zero represents the lowest or poorest category and 100 represents the highest level of functioning. The overall quality of life score was calculated by taking the mean of the subscale scores. (NCT02091375)
Timeframe: Baseline to EOT (Day 99) or ET

Interventionunits on a scale (Least Squares Mean)
GWP42003-P 20 mg/kg/Day Dose5.6
Placebo4.1

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Change From Baseline In Epworth Sleepiness Scale (ESS) Score

The ESS questionnaire was completed by the participant's caregiver. The change from baseline in the ESS score was analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6- to 2 years and 13 to 18 years) as covariates and treatment group as a fixed factor. The total score was the sum of the 8 item-scores and ranged from 0 to 24. A higher total score represents greater levels of daytime sleepiness. (NCT02091375)
Timeframe: Baseline to Last Visit (Day 99) or ET

Interventionunits on a scale (Least Squares Mean)
GWP42003-P 20 mg/kg/Day Dose0.82
Placebo-0.69

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Number Of Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period

Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. (NCT02091375)
Timeframe: Baseline to EOT (Day 99) or ET

InterventionParticipants (Count of Participants)
GWP42003-P 20 mg/kg/Day Dose26
Placebo16

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Caregiver Global Impression Of Change In Seizure Duration (CGICSD)

"Seizure duration was assessed qualitatively using the CGICSD. Caregivers were asked Since the patient started treatment, please assess the average duration of the patient's seizures (comparing their condition now to their condition before treatment); responses included decrease, no change, or increase in average duration. For each seizure type, only participants with at least 1 seizure for the corresponding seizure type, reported at any time during the study, were included." (NCT02091375)
Timeframe: Baseline to EOT (Day 99) or ET

InterventionParticipants (Count of Participants)
Tonic-Clonic Seizures71949684Tonic-Clonic Seizures71949683Tonic Seizures71949684Tonic Seizures71949683Clonic Seizures71949683Clonic Seizures71949684Atonic Seizures71949684Atonic Seizures71949683Myoclonic Seizures71949683Myoclonic Seizures71949684Countable Partial Seizures71949684Countable Partial Seizures71949683Other Partial Seizures71949683Other Partial Seizures71949684Absence Seizures71949683Absence Seizures71949684
Decrease in average durationNo change in average durationIncrease in average duration
GWP42003-P 20 mg/kg/Day Dose17
Placebo8
GWP42003-P 20 mg/kg/Day Dose32
Placebo31
GWP42003-P 20 mg/kg/Day Dose8
GWP42003-P 20 mg/kg/Day Dose5
GWP42003-P 20 mg/kg/Day Dose6
GWP42003-P 20 mg/kg/Day Dose2
Placebo2
GWP42003-P 20 mg/kg/Day Dose1
Placebo3
GWP42003-P 20 mg/kg/Day Dose0
GWP42003-P 20 mg/kg/Day Dose4
GWP42003-P 20 mg/kg/Day Dose10
GWP42003-P 20 mg/kg/Day Dose7
Placebo9
GWP42003-P 20 mg/kg/Day Dose3
Placebo0
Placebo6
GWP42003-P 20 mg/kg/Day Dose11
Placebo12
Placebo1

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Change From Baseline In Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score

The Vineland-II scores (standard scores and adaptive levels for each adaptive behavior domain, the adaptive behavior composite, and the maladaptive behavior index score and level) were assessed by the participant's caregiver. Scores were analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6 to 12 years, and 13 to 18 years) as covariates and treatment group as a fixed factor. Higher scores represent greater levels of functioning except for the maladaptive behavior index, for which a negative change from baseline represents an improvement in condition. (NCT02091375)
Timeframe: Baseline to Last Visit (Day 99) or ET

,
Interventionunits on a scale (Least Squares Mean)
Communication Domain Standard ScoreDaily Living Skills Domain Standard ScoreSocialization Domain Standard ScoreMotor Skills Domain Standard ScoreAdaptive Behavior Composite Standard ScoreMaladaptive Behavior Index v-Scale Score
GWP42003-P 20 mg/kg/Day Dose-0.8-0.8-0.6-2.5-2.0-0.3
Placebo3.0-0.8-0.61.70.6-0.4

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Percentage Change From Baseline In Non-Convulsive Seizure Frequency During The Treatment Period

Non-convulsive seizures (myoclonic, partial, or absence) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Only participants with non-convulsive seizures during the baseline period were included. Negative percentages show an improvement from baseline. (NCT02091375)
Timeframe: Baseline to EOT (Day 99) or ET

Interventionpercent change (Median)
GWP42003-P 20 mg/kg/Day Dose-40.16
Placebo-34.69

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Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period

Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) * 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) * 28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline. (NCT02091375)
Timeframe: Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)

Interventionpercent change (Median)
GWP42003-P 20 mg/kg/Day Dose-38.94
Placebo-13.29

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Number Of Participants Using Rescue Medication

The use of rescue medication was recorded by the participant or caregiver using a paper diary. (NCT02091375)
Timeframe: Baseline to EOT (Day 99) or ET

InterventionParticipants (Count of Participants)
GWP42003-P 20 mg/kg/Day Dose36
Placebo41

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Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period

Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. (NCT02091375)
Timeframe: Baseline to EOT (Day 99) or ET

,
InterventionParticipants (Count of Participants)
≥25% Reduction≥75% Reduction100% Reduction
GWP42003-P 20 mg/kg/Day Dose38143
Placebo2670

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Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period

Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic, or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure. (NCT02224560)
Timeframe: Baseline to EOT (Day 99) or ET

InterventionParticipants (Count of Participants)
GWP42003-P 20 mg/kg/Day Dose30
GWP42003-P 10 mg/kg/Day Dose26
Placebo11

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Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period

Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline. (NCT02224560)
Timeframe: Baseline to EOT (Day 99) or ET

Interventionpercentage change (Median)
GWP42003-P 20 mg/kg/Day Dose-38.40
GWP42003-P 10 mg/kg/Day Dose-36.44
Placebo-18.47

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Subject/Caregiver Global Impression Of Change (S/CGIC) Assessment

"The S/CGIC was used to assess the participant's overall condition on a 7-point scale, using the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed." (NCT02224560)
Timeframe: Baseline to Last Visit (Day 99) or ET

,,
InterventionParticipants (Count of Participants)
Very Much ImprovedMuch ImprovedSlightly ImprovedNo ChangeSlightly WorseMuch WorseVery Much Worse
GWP42003-P 10 mg/kg/Day Dose9142521310
GWP42003-P 20 mg/kg/Day Dose6152225610
Placebo182435430

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Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period

Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) x 28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline. (NCT02224560)
Timeframe: Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)

Interventionpercentage change (Median)
GWP42003-P 20 mg/kg/Day Dose-41.86
GWP42003-P 10 mg/kg/Day Dose-37.16
Placebo-17.17

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Both Hands Z Score)

Purdue Pegboard test was used to measure fine motor dexterity of both hands. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionZ Score (Mean)
Dravet Syndrome1.26
Lennox-Gastaut Syndrome9.55

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Dominant Hand Z Score)

Purdue Pegboard test was used to measure fine motor dexterity of the dominant hand. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionZ Score (Mean)
Dravet Syndrome1.16
Lennox-Gastaut Syndrome9.23

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Non Dominant Hand Z Score)

Purdue Pegboard test was used to measure fine motor dexterity of the non dominant hand. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionZ Score (Mean)
Dravet Syndrome1.31
Lennox-Gastaut Syndrome10.21

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Quality of Life in Childhood Epilepsy (QOLCE) Scores

The QOLCE is a parent-reported questionnaire that evaluates health-related QOL in children aged 2-18 years old. It contains 76 items with 16 subscales covering 7 domains (physical activities, social activities, cognition, emotional well-being, behavior, general health, and general QOL). All items in the questionnaire are rated on a 5-point or 6-point categorical scale. Based on the responses to the items in each domain, scores for 16 subscales are derived. Score range from 0 to 100. Higher score indicate highest level of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as the Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScores on a scale (Mean)
Dravet Syndrome3.7
Lennox-Gastaut Syndrome6.0

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Red Blood Cells (RBCs) Values

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Intervention10^12 cells per Liter (L) (Mean)
Dravet Syndrome-0.068
Lennox-Gastaut Syndrome-0.059

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Visual Perception Standard Scaled Score

"Visual Perception Standard scale was used to measure visual motor functioning. The raw score i.e., the sum of the correct responses was measured on a 6-standard score range. Score range of 70-79 indicated low, 80-89 indicated below average, 90-109 indicated average, 110-119 indicated above average, 120-129 indicated high, and >129 indicated very high visual motor functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in visual motor functioning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study." (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.00
Lennox-Gastaut Syndrome2.67

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WASI-II Matrix Reasoning T Score

WASI-II Matrix Reasoning T Score was used to estimate general intellectual ability based abstract reasoning. The raw score i.e., the sum of correct responses was converted to a T-score ranging from 20-80 using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionT Score (Mean)
Dravet Syndrome-1.50
Lennox-Gastaut Syndrome-3.29

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Abbreviated Scale of Intelligence (WASI)-II Vocabulary T Score

WAIS-II Vocabulary T Score was used to estimate general intellectual ability based on fund of information and verbal intelligence. The raw score i.e., the sum of correct responses was converted to a T-score ranging from 20-80 using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of intelligence. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in intelligence. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionT Score (Mean)
Dravet Syndrome0.00
Lennox-Gastaut Syndrome-4.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Adult Intelligence Scale (WAIS) Coding Scaled Score

WAIS Coding Scale was used to measure processing speed. The raw score i.e., sum of correct substitutions was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Lennox-Gastaut Syndrome0.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Intelligence Scale for Children (WISC) Coding Scaled Score

WISC Coding Scale was used to measure processing speed in children aged 6-16 years 11 months, with scores ranging from 0 to 119. Higher scores indicate better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome-0.40

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Backward Scaled Score

WISC Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured on a scale of 0-18; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Forward Scaled Score

WISC Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured on a scale of 0-18; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.57

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Backward Scaled Score

WISC Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured on a scale of 2-8; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Forward Scaled Score

WISC Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured on a scale of 2-10; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.17

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Receptive Vocabulary T Score

WPPSI-IV Receptive Vocabulary T Score was used to measure fund of information. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of intelligence. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in intelligence. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionT Score (Mean)
Lennox-Gastaut Syndrome-1.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment QOL in Epilepsy Scores (QOLIE-31-P) in Participants With Lennox-Gastaut Syndrome

The QOLIE-31-P is a survey of health-related QOL for adults with epilepsy. It is comprised of 38 questions about health daily activities and evaluates how much distress the participant feels about problems and worries related to epilepsy. The questionnaire consists of 7 subscales (energy, mood, daily activities, cognition, medication effects, seizure worry, and overall QOL). Scores range from 0 to 100. Higher scores indicate better QOL. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Lennox-Gastaut Syndrome participants only. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScores on a scale (Mean)
Lennox-Gastaut Syndrome1.3

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Mean Subject/Caregiver Global Impression of Change (S/CGIC) Score

The S/CGIC allows participants and caregivers to rate the participant's overall condition on a scale of 1 to 7 (1 = Very Much Improved, and 7 = Very Much Worse). The combined caregiver and participant summary used either the caregiver or participant version if only one version was completed, or the caregiver version when both the caregiver and participant versions were completed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScores on a scale (Mean)
Dravet Syndrome3.0
Lennox-Gastaut Syndrome2.8

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Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up

The Cannabis Withdrawal Scale is a 19-item scale administered to participants (18 years and above), with each item (withdrawal symptom) measured on a 0 to 10 numerical rating scale (0 = Not at all; 5 = Moderately; 10 = Extremely). Total score, calculated as the sum of the 19 item sub-scores ranging from 0-190 are reported. Higher scores indicate more withdrawal symptoms and an increased negative impact to quality of life. The participant or participant's caregiver was asked to record the extent to which each withdrawal symptom was experienced in the last 24 hours and also to rate the negative impact on normal daily activities. L24S = Last 24 Hours Score; NIS = Negative Impact on Normal Daily Activity Score. The End of Treatment visit occurred after a maximum of 260 weeks of treatment. The End of Taper occurred up to 10 days after the End of Treatment visit. The Safety Call and Safety Follow-up occurred 2 and 4 weeks, respectively, after the End of Taper. (NCT02224573)
Timeframe: up to Week 260

,
Interventionscores on a scale (Mean)
L24S, End of TaperL24S, Post-Taper Safety CallL24S, Safety Follow-UpNIS, End of TaperNIS, Post-Taper Safety CallNIS, Safety Follow-Up
Dravet Syndrome9.83.42.49.516.35.3
Lennox-Gastaut Syndrome4.90.04.95.11.21.8

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Albumin and Protein

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

,
Interventiongrams (g)/L (Mean)
AlbuminProtein
Dravet Syndrome-0.2-1.2
Lennox-Gastaut Syndrome-0.9-2.0

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, and Gamma Glutamyl Transferase

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

,
InterventionUnits/L (Mean)
Alkaline phosphataseAspartate aminotransferaseAlanine aminotransferaseGamma glutamyl transferase
Dravet Syndrome-40.94.07.08.7
Lennox-Gastaut Syndrome-40.12.89.54.9

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine (Jaffe), Creatinine (Enzymatic), and Bilirubin

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

,
Interventionmicromoles per Liter (µmol/L) (Mean)
Creatinine, JaffeCreatinine, enzymaticBilirubin
Dravet Syndrome7.03.80.48
Lennox-Gastaut Syndrome7.14.00.45

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine Clearance (Schwartz) and Creatinine Clearance (Cockcroft-Gault)

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. mL/min/1.73 m^2 = millilitres per minute per 1.73 meters squared. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

,
InterventionmL/min/1.73 m^2 (Mean)
Creatinine Clearance, Schwartz,Creatinine Clearance, Cockcroft-Gault
Dravet Syndrome0.30.0
Lennox-Gastaut Syndrome0.0-0.6

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

,
Intervention10^9 cells/L (Mean)
PlateletsWhite blood cellsBasophilsEosinophilsLymphocytesMonocytesNeutrophils
Dravet Syndrome5.4-0.520.00-0.02-0.31-0.05-0.16
Lennox-Gastaut Syndrome5.0-0.090.01-0.02-0.140.010.05

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to week 260

,
Interventionmillimoles per Liter (mmol/L) (Mean)
SodiumPotassiumBlood urea nitrogenGlucoseCalciumHDL cholesterol
Dravet Syndrome-0.4-0.06-0.08-0.06-0.0500.06
Lennox-Gastaut Syndrome-0.8-0.080.000.06-0.0540.12

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs)

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

,
Interventionpercentage in WBCs (Mean)
Basophils/WBCsEosinophils/WBCsLymphocytes/WBCsMonocytes/WBCsNeutrophils/WBCs
Dravet Syndrome0.08-0.10-1.32-0.051.47
Lennox-Gastaut Syndrome0.12-0.24-1.320.181.27

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores

"The Vineland-II is an individually administered instrument for assessing adaptive behaviors. It consists of 4 adaptive behavior domains (1 = low; 5 = high) and a maladaptive behavior domain (1 = clinically significant; 3 = average), and an overall Adaptive Behavior Composite Score. Standard scores (population mean = 100, SD = 15, range = 20 to 160) are produced for the domain and composite scores, and scaled scores (called v-scale scores, with a population mean = 15, SD = 3, range = 1 to 24) are produced for the subscale scores. Higher scores indicate better functioning.~Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study." (NCT02224573)
Timeframe: Baseline; up to Week 260

,
InterventionScores on a scale (Mean)
Communication: Receptive Subdomain v-Scale ScoreCommunication: Expressive Subdomain v-Scale ScoreCommunication: Written Subdomain v-Scale ScoreCommunication Domain Standard ScoreDaily Living Skills: Personal Subdomain v-Scale ScoreDaily Living Skills: Domestic Subdomain v-Scale ScoreDaily Living Skills: Community Subdomain v-Scale ScoreDaily Living Skills Domain Standard ScoreSocialization: Interpersonal Relationships Subdomain v-Scale ScoreSocialization: Play and Leisure Time Subdomain v-Scale ScoreSocialization: Coping Skills Subdomain v-Scale ScoreSocialization Domain Standard ScoreMotor Skills: Gross Subdomain v-Scale ScoreMotor Skills: Fine Subdomain v-Scale ScoreMotor Skills Domain Standard ScoreAdaptive Behavior Composite Standard ScoreMaladaptive Behavior Index: Internalizing Subdomain v-Scale ScoreMaladaptive Behavior Index: Externalizing Subdomain v-Scale ScoreMaladaptive Behavior Index v-Scale Score
Dravet Syndrome-0.4-0.8-1.1-3.2-1.0-0.8-0.9-5.0-0.7-0.9-0.7-3.3-0.2-0.3-0.7-3.4-0.1-0.3-0.3
Lennox-Gastaut Syndrome-0.5-0.3-0.7-1.6-0.8-1.0-0.8-3.9-0.6-0.4-0.5-3.4-0.3-0.4-1.9-2.5-0.1-0.1-0.3

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score

WAIS Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
BaselineWeek 48
Dravet Syndrome0.00.0

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score

WAIS Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
BaselineWeek 48End of Treatment
Lennox-Gastaut Syndrome0.00.25-0.14

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score

WAIS Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
BaselineWeek 48
Dravet Syndrome0.00.0

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score

WAIS Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
BaselineWeek 48End of Treatment
Lennox-Gastaut Syndrome0.13-0.250.14

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score

WAIS Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
BaselineWeek 48
Dravet Syndrome0.000.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score

WAIS Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
BaselineWeek 48End of Treatment
Lennox-Gastaut Syndrome0.000.000.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score

WAIS Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
BaselineWeek 48
Dravet Syndrome0.00.0

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score

WAIS Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
BaselineWeek 48End of Treatment
Lennox-Gastaut Syndrome0.130.25-0.14

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Matrix Reasoning T Score

WPPSI-IV Matrix Reasoning T Score was used to measure abstract reasoning. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionT Score (Mean)
Baseline
Lennox-Gastaut Syndrome-19.0

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Matrix Reasoning T Score

WPPSI-IV Matrix Reasoning T Score was used to measure abstract reasoning. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionT Score (Mean)
BaselineWeek 48
Dravet Syndrome0.75-0.75

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Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group

TEAEs, defined as AEs that started, or worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, are reported. Any AEs that continued from the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) were only classified as treatment emergent if they worsened in this study. (NCT02224573)
Timeframe: up to Week 260

,
Interventionparticipants (Number)
Total participants affected by any TEAEDiarrhoeaVomitingConstipationNauseaPyrexiaFatigueUpper respiratory tract infectionNasopharyngitisSinusitisPneumoniaEar infectionInfluenzaUrinary tract infectionPharyngitis streptococcalGastroenteritis viralOtitis mediaBronchitisViral upper respiratory tract infectionGastroenteritisFallLacerationContusionWeight decreasedAlanine aminotransferase increasedAspartate aminotransferase increasedGamma-glutamyltransferase increasedDecreased appetiteConvulsionSomnolenceStatus epilepticusLethargyHeadacheSedationDroolingAbnormal behaviourInsomniaIrritabilityAggressionAgitationCoughNasal congestionRhinorrhoeaPneumonia aspirationHypoxia
Dravet Syndrome30613563201612439787838353537192615211511162281521373832997987472118161134162620942132042
Lennox-Gastaut Syndrome353140107433212638104584951504551273022232072335256130192093141107423426272123402930196346192221

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Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose

Clinical significance was determined by the investigator. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. msec = milliseconds; QTcB = corrected QT interval with Bazett's correction. The time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

,
Interventionparticipants (Number)
QTcB > 450 msec, BaselineQTcB > 450 msec, any time post-doseQTcB > 480 msec, BaselineQTcB > 480 msec, any time post-doseQTcB > 500 msec, BaselineQTcB > 500 msec, any time post-dose
Dravet Syndrome136221027
Lennox-Gastaut Syndrome21120440220

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Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus)

"Status epilepticus is defined as any seizure lasting for 30 minutes or longer. The number of convulsive seizures greater than 30 minutes in duration and the number of non-convulsive seizures greater than 30 minutes in duration were collected weekly. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. mins = minutes. Last 12 weeks is equal to the last 12 weeks' data for each participant irrespective of time in study." (NCT02224573)
Timeframe: Baseline; At last 12 weeks

,
Interventionparticipants (Number)
Convulsive SE: Over the 4-week Baseline; YesConvulsive SE: Last 12 Weeks; YesConvulsive SE: Over the 4-week Baseline; NoConvulsive SE: Last 12 Weeks; NoNon-Convulsive SE: Over the 4-week Baseline; YesNon-Convulsive SE: Last 12 Weeks; YesNon-Convulsive SE: Over the 4-week Baseline; NoNon-Convulsive SE: Last 12 Weeks; No
Dravet Syndrome14132772772114270276
Lennox-Gastaut Syndrome1473523561711349352

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Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose

The C-SSRS questionnaire is a brief, standardized measure that uniquely assesses the essential information (behavior, ideation, lethality, and severity) and distinguishes between suicidal occurrences and non-suicidal self-injury. (NCT02224573)
Timeframe: up to Week 260

,
Interventionparticipants (Number)
Any suicidality, Day 1Any suicidality, any time post-doseSuicidal ideation, Day 1Suicidal ideation, any time post-doseSuicidal behavior, Day 1Suicidal behavior, any time post-doseComplete suicidality, any time post-dose
Dravet Syndrome1101110
Lennox-Gastaut Syndrome1212000

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Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures

Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver. (NCT02224573)
Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

InterventionParticipants (Count of Participants)
Week 49 to 60Week 97 to 108Week 145 to 156Week 205 to 216Last 12 Weeks
Lennox-Gastaut Syndrome16914812812188

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Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures

Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver. (NCT02224573)
Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

InterventionParticipants (Count of Participants)
Week 49 to 60Week 97 to 108Week 145 to 156Week 205 to 216Week 253 to 264Last 12 Weeks
Dravet Syndrome108734872153

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Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome

"Convulsive seizures are defined as tonic-clonic, tonic, clonic, or atonic seizures. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Dravet Syndrome participants only. Last 12 weeks is equal to the last 12 weeks' data for each participant irrespective of time in study." (NCT02224573)
Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Interventionpercentage change (Median)
Week 49 to 60Week 97 to 108Week 145 to 156Week 205 to 216Week 253 to 264Last 12 weeks
Dravet Syndrome-52.9-64.3-69.4-72.3-55.6-40.0

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Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome

"Drop seizures are defined as the subset of tonic-clonic, tonic, or atonic seizures. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Lennox-Gastaut Syndrome participants only. Last 12 weeks is equal to the last 12 weeks' data for each participant irrespective of time in study." (NCT02224573)
Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, and Last 12 Weeks

Interventionpercentage change (Median)
Week 49 to 60Week 97 to 108Week 145 to 156Week 205 to 216Last 12 weeks
Lennox-Gastaut Syndrome-59.4-69.4-70.8-68.7-59.4

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Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency

"Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. Last 12 weeks is equal to the last 12 weeks' data for each participant irrespective of time in study." (NCT02224573)
Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Interventionpercentage change (Median)
Week 49 to 60Week 97 to 108Week 145 to 156Week 205 to 216Last 12 weeks
Lennox-Gastaut Syndrome-58.9-66.4-65.3-78.4-51.9

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Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency

"Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. Last 12 weeks is equal to the last 12 weeks' data for each participant irrespective of time in study." (NCT02224573)
Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Interventionpercentage change (Median)
Week 49 to 60Week 97 to 108Week 145 to 156Week 205 to 216Week 253 to 264Last 12 weeks
Dravet Syndrome-65.8-71.3-79.8-81.5-70.0-55.2

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Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD)

The SGICSD and CGICSD are comprised of the following questions rated on a 3-point scale for each seizure type. The CGICSD score is used to assess the average duration of the participant's seizures (comparing their condition now to their condition before treatment) and the SGICSD score is used to assess the average duration of seizures (comparing condition now to condition before treatment). Scores range from 1 to 3 (1 = Decrease in average duration; 3 = Increase in average duration). (NCT02224573)
Timeframe: Up to Week 260

InterventionParticipants (Count of Participants)
Tonic-Clonic Seizures; End of Treatment72562296Tonic-Clonic Seizures; End of Treatment72562297Tonic Seizures; End of Treatment72562296Tonic Seizures; End of Treatment72562297Clonic Seizures; End of Treatment72562297Clonic Seizures; End of Treatment72562296Atonic Seizures; End of Treatment72562296Atonic Seizures; End of Treatment72562297Myoclonic Seizures; End of Treatment72562296Myoclonic Seizures; End of Treatment72562297Countable Partial Seizures; End of Treatment72562296Countable Partial Seizures; End of Treatment72562297Other Partial Seizures; End of Treatment72562296Other Partial Seizures; End of Treatment72562297Absence Seizures; End of Treatment72562297Absence Seizures; End of Treatment72562296
Increase in average durationDecrease in average duration
Dravet Syndrome89
Lennox-Gastaut Syndrome101
Dravet Syndrome17
Lennox-Gastaut Syndrome24
Dravet Syndrome39
Lennox-Gastaut Syndrome132
Lennox-Gastaut Syndrome18
Dravet Syndrome41
Lennox-Gastaut Syndrome38
Dravet Syndrome4
Dravet Syndrome26
Lennox-Gastaut Syndrome98
Lennox-Gastaut Syndrome10
Dravet Syndrome48
Lennox-Gastaut Syndrome72
Dravet Syndrome14
Lennox-Gastaut Syndrome4
Dravet Syndrome34
Lennox-Gastaut Syndrome41
Dravet Syndrome8
Lennox-Gastaut Syndrome5
Dravet Syndrome25
Lennox-Gastaut Syndrome29
Dravet Syndrome6
Lennox-Gastaut Syndrome0
Dravet Syndrome42
Lennox-Gastaut Syndrome83
Dravet Syndrome9
Lennox-Gastaut Syndrome3

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Hemoglobin

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Interventionpicograms (pg) (Mean)
Dravet Syndrome0.10
Lennox-Gastaut Syndrome-0.15

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Mean Pediatric Cannabinoid Withdrawal Scale (PCWS) Score at the End of Treatment, the End of Taper, the Post-Taper Safety Call, and at Safety Follow-up

The PCWS was administered to participants aged 4 to 17 (inclusive) that was developed from the 19-item validated CWS (adults) to assess mood, behavioral, and physical symptoms associated with cannabis. The total score, calculated as the sum of 10 items (rated on a 4-point scale: 0 = none; 1 = a little bit; 2 = quite a bit; 3 = a lot) ranging from 0-30 are reported. Higher scores indicate more withdrawal symptoms and an increased negative impact to quality of life. The End of Treatment visit occurred after a maximum of 260 weeks of treatment. The participant or participant's caregiver was asked to record the extent to which each withdrawal symptom was experienced in the last 24 hours and also to rate the negative impact on normal daily activities. The End of Taper occurred up to 10 days after the End of Treatment visit. The Safety Call and Safety Follow-up occurred 2 and 4 weeks, respectively, after the End of Taper. (NCT02224573)
Timeframe: up to Week 260

,
Interventionscores on a scale (Mean)
End of TreatmentEnd of TaperPost-Taper Safety CallSafety Follow-Up
Dravet Syndrome4.02.92.41.9
Lennox-Gastaut Syndrome6.02.12.01.8

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Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose

Clinical significance was determined by the investigator. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. bpm = beats per minute; DBP = Diastolic Blood Pressure; mmHg = millimeters of mercury; SBP = Systolic Blood Pressure. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

,
Interventionparticipants (Number)
Sitting SBP < -20 mmHgSitting SBP > 20 mmHgSitting DBP < -10 mmHgSitting DBP > 10 mmHgPulse Rate < -15 bpmPulse Rate > 15 bpmWeight ≤ -7 %Weight ≥ 7%
Dravet Syndrome599613916617615047213
Lennox-Gastaut Syndrome88120176191192179106223

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in a Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scaled Score

Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scale was used to measure verbal fluency. The raw score i.e., the sum of correct responses was converted to a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicate a higher level of verbal fluency. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in verbal fluency. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome-1.00
Lennox-Gastaut Syndrome3.39

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Body Mass Index (BMI)

BMI is an estimate of body fat based on body weight divided by height squared. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Interventionkilograms per meters squared (kg/m^2) (Mean)
Dravet Syndrome0.42
Lennox-Gastaut Syndrome0.05

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Letter Sequencing Completion Time Scaled Score

D-KEFS Letter Sequencing Completion Time Scaled was used to measure processing speed. The raw score i.e., total time in seconds for completing the letter sequencing trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.00
Lennox-Gastaut Syndrome0.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Motor Speed Completion Time Scaled Score

D-KEFS Motor Speed Completion Time Scale was used to measure motor speed. The raw score i.e., total time in seconds for completing the motor speed trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better motor speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in motor speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.00
Lennox-Gastaut Syndrome-1.33

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number Sequencing Completion Time Scaled Score

D-KEFS Number Sequencing Completion Time Scale was used to measure processing speed. The raw score i.e., total time in seconds for completing the number sequencing trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to convert into a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.00
Lennox-Gastaut Syndrome0.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number-letter Switching Completion Time Scaled Score

D-KEFS Number-letter Switching Completion Time Scale was used to measure cognitive flexibility, task-set switching, and general executive functioning. The raw score i.e., total time in seconds for completing the number-letter switching trial was measured in the range of 0-240; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in cognitive function. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.00
Lennox-Gastaut Syndrome0.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Delis-Kaplan Executive Function System (D-KEFS) Visual Scanning Completion Time Scaled Score

D-KEFS Visual Scanning Completion Time Scale was used to measure visual attention and processing speed. The cognitive assessment battery items are age-specific, used to measure a variety of functions for both children and adults. The items were administered by an experienced psychometrician to a sub-group of sites that had the expertise to conduct the test. The raw score i.e., total time in seconds for completing the visual scanning trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to convert into a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in cognitive function. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionScore on a scale (Mean)
Dravet Syndrome0.00
Lennox-Gastaut Syndrome-0.33

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Volume

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Interventionfemtoliters (fL) (Mean)
Dravet Syndrome-1.0
Lennox-Gastaut Syndrome-1.3

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Expressive One-Word Picture Vocabulary Test (EOWPVT) Scaled Score

Expressive One-Word Picture Vocabulary Test-4th edition was used to test vocabulary. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 0-83; T-scores are standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate a higher level of language performance. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in language performance. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: Baseline; up to Week 260

InterventionT score (Mean)
Dravet Syndrome-31.00
Lennox-Gastaut Syndrome-31.00

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hematocrit Values

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Interventionpercentage of RBCs in whole blood (L/L) (Mean)
Dravet Syndrome-0.0105
Lennox-Gastaut Syndrome-0.0110

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hemoglobin Levels

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Interventiongrams per Liter (g/L) (Mean)
Dravet Syndrome-1.6
Lennox-Gastaut Syndrome-2.4

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Insulin-like Growth Factor-1 (IGF-1) Levels

IGF-1 levels in serum were analyzed as part of the clinical laboratory testing in participants. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Interventionnanomoles (nmol)/L (Mean)
Dravet Syndrome-0.28
Lennox-Gastaut Syndrome1.10

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prolactin

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

InterventionµInternational Units/millilitre (µIU/mL) (Mean)
Dravet Syndrome0.43
Lennox-Gastaut Syndrome10.43

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin International Normalized Ratio

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Interventionratio (Mean)
Dravet Syndrome-0.012
Lennox-Gastaut Syndrome-0.010

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Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin Time

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. (NCT02224573)
Timeframe: up to Week 260

Interventionseconds (Mean)
Dravet Syndrome-0.08
Lennox-Gastaut Syndrome-0.09

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Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period

Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: (frequency during the treatment period - frequency during baseline/frequency during baseline) * 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) *28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline. (NCT02224690)
Timeframe: Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)

Interventionpercentage change (Median)
GWP42003-P 20 mg/kg/Day Dose-43.90
Placebo-21.80

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Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period

Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure. (NCT02224690)
Timeframe: Baseline to EOT (Day 99) or ET

InterventionParticipants (Count of Participants)
GWP42003-P 20 mg/kg/Day Dose38
Placebo20

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Subject/Caregiver Global Impression Of Change Assessment (S/CGIC)

"The S/CGIC was used to assess the participant's overall condition on a 7-point scale, using the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed." (NCT02224690)
Timeframe: Baseline to Last Visit (Day 99) or ET

,
InterventionParticipants (Count of Participants)
Very Much ImprovedMuch ImprovedSlightly ImprovedNo ChangeSlightly WorseMuch WorseVery Much Worse
GWP42003-P 20 mg/kg/Day Dose15142027710
Placebo591543922

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Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period

Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline. (NCT02224690)
Timeframe: Baseline to EOT (Day 99) or ET

Interventionpercentage change (Median)
GWP42003-P 20 mg/kg/Day Dose-41.24
Placebo-13.70

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Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period

Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an IVRS diary. Baseline included all available data prior to Day 1 (28-day average). Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) x 28. Baseline included all available data prior to Day 1 (28-day average). (NCT02224703)
Timeframe: Baseline to Day 99 or ET

InterventionParticipants (Count of Participants)
10 mg/kg/Day GWP42003-P29
20 mg/kg/Day GWP42003-P33
Placebo Control17

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Change In Total Seizures During The Treatment Period Compared To Baseline

Total seizures were defined as the combination of convulsive and non-convulsive seizures. Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic seizures. Non-convulsive seizures were defined as myoclonic, countable partial, other partial, or absence seizures. Participants or their caregivers recorded the number and type of convulsive seizures and non-convulsive seizures each day from screening until completion of dosing using an IVRS diary. Change compared to baseline was calculated as per the primary outcome measure. Data reported as the ratio of geometric least squares mean in total seizures and expressed as a percentage reduction. (NCT02224703)
Timeframe: Baseline to Day 99 or ET

Interventionpercentage reduction (Geometric Least Squares Mean)
10 mg/kg/Day GWP42003-P56.4
20 mg/kg/Day GWP42003-P47.3
Placebo Control29.7

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Change In Convulsive Seizures During The Treatment Period Compared To Baseline

Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an interactive voice response system (IVRS) diary. The primary endpoint was analyzed using negative binomial regression on the sum of the convulsive seizure counts during the treatment period, based on the ITT analysis set. Baseline included all available data prior to Day 1. Data reported as the ratio of geometric least squares mean in convulsive seizures and expressed as a percentage reduction. (NCT02224703)
Timeframe: Baseline to Day 99 or Early Termination (ET)

Interventionpercentage reduction (Geometric Least Squares Mean)
10 mg/kg/Day GWP42003-P48.7
20 mg/kg/Day GWP42003-P45.7
Placebo Control26.9

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Percentage of Participants With Adverse Events

An Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. (NCT02318602)
Timeframe: Up to Week 50

InterventionPercentage of participants (Number)
Infants88.9
Children92.3
Adolescents88.2
All Participants90.4

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Vineland Adaptive Behavior Scales (VABS)

"The Vineland Adaptive Behavior Scales measures the personal and social skills of individuals from birth through adulthood. Because adaptive behavior refers to an individual's typical performance of the day-to-day activities required for personal and social sufficiency, these scales assess what a person actually does, rather than what he or she is able to do.~The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. The 4 domains are Communication, Daily Living Skills, Motor Skills, and Maladaptive Behaviour Index. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. A rise in standard scores from Baseline indicates improvement.~The VABS will be completed for all participants." (NCT02318602)
Timeframe: Up to Week 48

,
InterventionScore on a scale (Mean)
Communication: Expressive (Day 1)Communication: Expressive (Week 36)Communication: Expressive (Week 48)Communication: Receptive (Day 1)Communication: Receptive (Week 36)Communication: Receptive (Week 48)Communication: Written (Day 1)Communication: Written (Week 36)Communication: Written (Week 48)Daily Living Skills: Community (Day 1)Daily Living Skills: Community (Week 36)Daily Living Skills: Community (Week 48)Daily Living Skills: Domestic (Day 1)Daily Living Skills: Domestic (Week 36)Daily Living Skills: Domestic (Week 48)Daily Living Skills: Personal (Day 1)Daily Living Skills: Personal (Week 36)Daily Living Skills: Personal (Week 48)Socialization: Coping Skills (Day 1)Socialization: Coping Skills (Week 36)Socialization: Coping Skills (Week 48)Socialization: Interpersonal Relationships (Day 1)Socialization: Interpersonal Relationships (Wk 36)Socialization: Interpersonal Relationships (Wk 48)Socialization: Play and Leisure Time (Day 1)Socialization: Play and Leisure Time (Week 36)Socialization: Play and Leisure Time (Week 48)Motor Skills: Fine (Day 1)Motor Skills: Fine (Week 36)Motor Skills: Fine (Week 48)Motor Skills: Gross (Day 1)Motor Skills: Gross (Week 36)Motor Skills: Gross (Week 48)Maladaptive Behavior Index: Externalizing (Day 1)Maladaptive Behavior Index: Externalizing (Wk 36)Maladaptive Behavior Index: Externalizing (Wk 48)Maladaptive Behavior Index: Internalizing (Day 1)Maladaptive Behavior Index: Internalizing (Wk 36)Maladaptive Behavior Index: Internalizing (Wk 48)Maladaptive Behavior Index: MBI Score (Day 1)Maladaptive Behavior Index: MBI Score (Week 36)Maladaptive Behavior Index: MBI Score (Week 48)Maladaptive Behavior Index: Other (Day 1)Maladaptive Behavior Index: Other (Week 36)Maladaptive Behavior Index: Other (Week 48)
Adolescents40.336.034.318.815.716.812.912.810.519.118.818.89.710.79.228.626.225.416.916.715.931.125.826.719.719.617.923.120.924.031.031.933.33.53.12.23.63.73.613.010.810.26.24.14.3
Children40.451.748.617.421.120.69.211.810.813.817.816.69.19.69.931.739.236.214.616.215.028.935.733.320.524.421.826.733.632.242.546.546.63.54.54.45.25.45.314.816.616.16.26.76.5

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Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

(NCT02318602)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Infants0
Children0
Adolescents0

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Vineland Adaptive Behavior Scales (VABS)

"The Vineland Adaptive Behavior Scales measures the personal and social skills of individuals from birth through adulthood. Because adaptive behavior refers to an individual's typical performance of the day-to-day activities required for personal and social sufficiency, these scales assess what a person actually does, rather than what he or she is able to do.~The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. The 4 domains are Communication, Daily Living Skills, Motor Skills, and Maladaptive Behaviour Index. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. A rise in standard scores from Baseline indicates improvement.~The VABS will be completed for all participants." (NCT02318602)
Timeframe: Up to Week 48

InterventionScore on a scale (Mean)
Communication: Expressive (Day 1)Communication: Expressive (Week 36)Communication: Expressive (Week 48)Communication: Receptive (Day 1)Communication: Receptive (Week 36)Communication: Receptive (Week 48)Communication: Written (Day 1)Communication: Written (Week 36)Communication: Written (Week 48)Daily Living Skills: Community (Day 1)Daily Living Skills: Community (Week 36)Daily Living Skills: Community (Week 48)Daily Living Skills: Domestic (Day 1)Daily Living Skills: Domestic (Week 36)Daily Living Skills: Domestic (Week 48)Daily Living Skills: Personal (Day 1)Daily Living Skills: Personal (Week 36)Daily Living Skills: Personal (Week 48)Socialization: Coping Skills (Day 1)Socialization: Coping Skills (Week 36)Socialization: Coping Skills (Week 48)Socialization: Interpersonal Relationships (Day 1)Socialization: Interpersonal Relationships (Wk 36)Socialization: Interpersonal Relationships (Wk 48)Socialization: Play and Leisure Time (Day 1)Socialization: Play and Leisure Time (Week 36)Socialization: Play and Leisure Time (Week 48)Motor Skills: Fine (Day 1)Motor Skills: Fine (Week 36)Motor Skills: Fine (Week 48)Motor Skills: Gross (Day 1)Motor Skills: Gross (Week 36)Motor Skills: Gross (Week 48)Maladaptive Behavior Index: Externalizing (Wk 36)Maladaptive Behavior Index: Externalizing (Wk 48)Maladaptive Behavior Index: Internalizing (Wk 36)Maladaptive Behavior Index: Internalizing (Wk 48)Maladaptive Behavior Index: MBI Score (Week 36)Maladaptive Behavior Index: MBI Score (Week 48)Maladaptive Behavior Index: Other (Week 36)Maladaptive Behavior Index: Other (Week 48)
Infants6.88.39.96.08.611.50.01.30.00.40.61.00.40.90.83.65.05.62.12.63.19.411.914.05.36.66.44.25.16.08.011.012.80.00.00.01.00.01.00.00.0

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Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values

Laboratory values include chemistry and hematology, and urinary analysis. (NCT02318602)
Timeframe: Up to Week 50

,,
InterventionPercentage of participants (Number)
HematologyBlood ChemistryUrinalysis
Adolescents000
Children000
Infants000

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Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)

For subjects 7 years of developmental age or older, the Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered to access suicidality. The appropriate adult version will be used in subjects 12 years of (developmental) age and older. The investigator will determine the participant's developmental age. (NCT02318602)
Timeframe: Up to Week 50

,,
InterventionParticipants (Count of Participants)
Suicidal IdeationSuicidal Behavior
Adolescents00
Children00
Infants00

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Percentage of Participants With Serious Adverse Events

A serious adverse event is any untoward medical occurrence ( whether considered to be related to investigational product or not) that at any dose results in death, is life threatening, requires inpatient hospitalization, results in disability/incapacity, is a congenital abnormality/ birth defect, or medically significant as determined by an investigator. (NCT02318602)
Timeframe: Up to Week 50

InterventionPercentage of participants (Number)
Infants77.8
Children38.5
Adolescents0
All Participants32.7

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Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs

(NCT02318602)
Timeframe: Up to Week 50

InterventionPercentage of participants (Number)
Infants0
Children0
Adolescents0

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Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.~MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)." (NCT02324673)
Timeframe: Day 1 at age-specific times

Interventionratio (Mean)
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]0.8935
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]0.9328
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]0.8081

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Dose Normalized AUC(0-inf) [AUC(0-inf)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionng*h/mL/(mg/kg) (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]83.1070.34
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]53.6446.07
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]111.868.43

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Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionng/mL/(mg/kg) (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]13.257.286
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]11.725.737
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]10.775.990

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Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Intervention1/h (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]0.039490.05123
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]0.029690.04053
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]0.028360.03276

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Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionnanograms/milliliter (ng/mL) (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]256.9140.9
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]59.0328.71
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]110.561.89

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Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionng/mL (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]118.3108.7
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]19.9721.82
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]41.6734.11

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present prior to the initiation of the treatment or any event already present that worsens. Any laboratory (clinical chemistry, hematology, urinalysis), 12-lead electrocardiograms, vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination findings deemed by the investigator to be clinically significant were captured as AEs. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention. (NCT02324673)
Timeframe: From the first dose of study drug up to Day 17

,,
InterventionParticipants (Count of Participants)
TEAESAE
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]172
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]130
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]91

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Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age

"Time linearity index is calculated as the ratio of AUC(0-12) on Day 10/AUC[0-inf] on Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis." (NCT02324673)
Timeframe: Day 1 and Day 10

,,
Interventionratio (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]4.2013.045
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]3.2112.500
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]2.6281.821

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Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionhours (h) (Median)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]3.153.07
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]2.582.55
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]4.004.00

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Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.~MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)." (NCT02324673)
Timeframe: Day 1 at age-specific times

Interventionratio (Mean)
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]0.9309
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]0.9793
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]0.9085

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Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.~MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)." (NCT02324673)
Timeframe: Day 10 at age-specific times

Interventionratio (Mean)
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]0.8795
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]0.7866
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]0.8700

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Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.~MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)." (NCT02324673)
Timeframe: Day 1 at age-specific times

Interventionratio (Mean)
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]0.9099
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]0.9459
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]0.9538

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MRCmax on Day 10

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.~MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)." (NCT02324673)
Timeframe: Day 10 at age-specific times

Interventionratio (Mean)
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]0.7717
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]0.8230
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]0.7657

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Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis." (NCT02324673)
Timeframe: Day 1 at age-specific times

InterventionLiters (L)/h/kg (Mean)
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]29.78
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]21.10
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]31.29

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Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionh (Median)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]3.002.03
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]2.992.08
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]2.002.03

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Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis." (NCT02324673)
Timeframe: Day 1 at age-specific times

InterventionL/kg (Mean)
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]1021
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]930.8
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]982.6

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Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol

"RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionratio (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]9.3767.541
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]5.4344.865
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]5.4894.524

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Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol

"RCmax is the ratio of Cmax at Day 10 compared to Cmax at Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionratio (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]7.4885.788
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]5.5353.823
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]4.4543.996

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Area Under the Plasma-Concentration Time Curve From 0 to 12 Hours Post-dose [AUC(0-12)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionng*h/mL (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]914.5646.7
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]173.9124.4
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]507.1329.8

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AUC From Time 0 to Infinity [AUC(0-inf)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionng*h/mL (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]15841354
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]270.1229.3
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]1140704.1

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AUC From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] on Day 1 for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionng*h/mL (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]13551221
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]250.0212.2
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]692.5544.9

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Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionh (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]21.5814.77
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]31.3119.71
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]33.4831.84

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AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionng*h/mL (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]27082165
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]581.6513.4
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]1098832.8

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Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionng/mL (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]225.7180.4
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]48.5642.94
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]91.3869.37

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Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment

The CGI-S was completed by the parents/caregivers and the Investigator and was used to rate participant's mental illness status at Baseline (Screening) and Day 11 using a 7-point scale, where 1=normal, not mentally ill, and 7=among the most extremely mentally ill participants. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The change in CGI-S score at Day 11 relative to Baseline is reported. A negative change from Baseline indicates improvement (decreased severity in illness). (NCT02324673)
Timeframe: Baseline and Day 11

,,
Interventionscores on a scale (Mean)
Parents/CaregiversInvestigator
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]-1.8-0.7
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]-1.7-1.1
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]-2.2-0.7

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Change From Baseline in Daily Seizure Activity

The specific number of tonic and atonic seizures per study day were recorded in a diary. The change in number of seizures at Day 11 relative to Baseline is reported. A negative change from Baseline indicates an improvement based on Daily Seizure Activity. (NCT02324673)
Timeframe: Baseline and Day 11

,,
Interventionnumber of seizures per day (Mean)
Number of Tonic SeizuresNumber of Atonic Seizures
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]-2.90.0
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]-0.8-0.2
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]-0.8-0.1

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Clinical Global Impression of Improvement (CGI-I) Assessment

The CGI-I was completed by the parents/caregivers and the investigator and was used to assess participants global status of their condition on Day 11 using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment. (NCT02324673)
Timeframe: Day 11

,,
Interventionscores on a scale (Mean)
Parents/CaregiversInvestigator
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]2.32.9
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]2.12.7
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]2.42.5

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Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionng/mL (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]426.8286.1
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]119.679.38
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]220.0136.6

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Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionng/mL/(mg/kg) (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]21.4014.39
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]23.7915.82
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]21.1613.10

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Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose." (NCT02324673)
Timeframe: Day 1 at age-specific times

,,
Interventionng*h/mL (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]47.1333.39
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]34.6024.88
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]49.2331.77

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Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10

"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose." (NCT02324673)
Timeframe: Day 10 at age-specific times

,,
Interventionng*h/mL/(mg/kg) (Mean)
Cannabidiol7-OH Cannabidiol
High Dose Cannabidiol Oral Solution [40 mg/kg/Day]135.7108.7
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]115.8102.2
Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]106.080.19

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Number of Seizures Per Month

A baseline seizure frequency was recorded for each subject in a diary for eight weeks prior to investigational drug initiation and parents/caregivers documented seizures on a daily basis throughout the trial using a seizure log. For assessing the efficacy of CBD, the investigator counted the change in frequency of seizures per month. The number of seizures within 56 days of the baseline and the number of seizures within 56 days of week 14 were calculated. Higher seizure frequency indicates worse outcome. This outcome is measured as the change in number of seizures per month between the baseline and week 14 time points. (NCT02332655)
Timeframe: Measured within 56 days before baseline and 56 days before week 14

InterventionSeizures per month (Mean)
Subject 1 Overall Average Number of Seizures per Month at BaselineSubject 1 Overall Average Number of Seizures per Month at Week 14Subject 2 Overall Average Number of Seizures per Month at BaselineSubject 2 Overall Average Number of Seizures per Month at Week 14Subject 3 (Re-enrolled) Overall Average Number of Seizures per Month at BaselineSubject 3 (Re-enrolled) Overall Average Number of Seizures per Month at Week 14Subject 4 Overall Average Number of Seizures per Month at BaselineSubject 4 Overall Average Number of Seizures per Month at Week 14Subject 5 Overall Average Number of Seizures per Month at Baseline
Cannabidiol33.530.03.00.53.02.05.00.51.0

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Percentage Change in Seizure Frequency at Most Recent Visit on CBD Compared With Baseline

The percentage change, between the seizure frequency per month reported at baseline compared to seizure frequency per month at the subject's most recent visit, on CBD was calculated. Higher positive percentage change in seizure frequency per month would indicate better outcome. Positive values indicate a decrease in seizure frequency. (NCT02332655)
Timeframe: Measured at Baseline and most recent visit within 1 year

InterventionPercentage Change in Seizure Frequency (Number)
Subject 1 Percent decrease in Seizure Frequency at Most Recent Visit on CBD Compared with BaselineSubject 2 Percent decrease in Seizure Frequency at Most Recent Visit on CBD Compared with BaselineSubject 3 Percent decrease in Seizure Frequency at Most Recent Visit on CBD Compared with BaselineSubject 4 Percent decrease in Seizure Frequency at Most Recent Visit on CBD Compared with Baseline
Cannabidiol121008364

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Positive and Negative Syndrome Scale (PANSS) Over Time

The Positive and Negative Syndrome Scale is a 30-item scale to assess both the positive and negative symptom symptoms of schizophrenia. The range total score is 30-210. An improvement in symptoms is reflected by a lower score. (NCT02504151)
Timeframe: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)

,
Interventionscore on a scale (Least Squares Mean)
Baseline period 1Week 1 period 1Week 2 period 1Week 3 period 1Week 4 period 1Baseline period 2Week 1 period 2Week 2 period 2Week 3 period 2Week 4 period 2
Cannabidiol, Then Placebo81.378.381.479.672.071.975.272.773.272.4
Placebo, Then Cannabidiol84.075.373.970.669.068.567.670.169.766.9

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Quality of Life Scale (QLS) Over Time

The Quality of Life Scale (QLS) is a 21-item scale rated from a semi structured interview, each item is rated 0-6. The specific descriptors vary among items, but the high end of the scales (scores of 5 and 6) reflects normal or unimpaired functioning, and the low end of the scales (scores of 0 and 1) reflects severe impairment of the function in question. A highest score of 126 would indicate unimpaired functioning. (NCT02504151)
Timeframe: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)

,
Interventionscore on a scale (Least Squares Mean)
Baseline period 1Week 1 period 1Week 2 period 1Week 3 period 1Week 4 period 1Baseline period 2Week 1 period 2Week 2 period 2Week 3 period 2Week 4 period 2
Cannabidiol, Then Placebo70.473.469.969.072.368.668.670.166.371.8
Placebo, Then Cannabidiol72.974.967.171.170.773.376.777.678.182.7

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Clinical Global Impression of Severity Scale Over Time

Clinical Global Impression of Severity Scale score is a global rating of improvement scale, which requires subjects to rate their degree of improvement on a 7-point scale. The total range score is 1-7. A reduction in scores indicates improvement. (NCT02504151)
Timeframe: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)

,
Interventionscore on a scale (Mean)
Baseline period 1Week 1 period 1Week 2 period 1Week 3 period 1Week 4 period 1Baseline period 2Week 1 period 2Week 2 period 2Week 3 period 2Week 4 period 2
Cannabidiol, Then Placebo4.14.14.44.44.34.34.34.34.34.3
Placebo, Then Cannabidiol4.24.24.24.44.44.34.04.44.24.2

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Patient Assessment of Own Functioning Inventory (PAOFI) Over Time

The PAOFI measures subjects' perceptions of functioning when performing everyday tasks and activities that reflect cognitive strengths and weaknesses. Subjects rate each item on a scale ranging from 0 (almost never) to 5 (almost always). The total score is the sum of the responses to each item (score of 0 to 160). High scores on the PAOFI subscales are indicative of poor perceived cognitive functioning. This scale was modified to remove 3 items- so the highest possible score is 145 for this outcome measure. (NCT02504151)
Timeframe: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)

,
Interventionscore on a scale (Least Squares Mean)
Baseline period 1Week 1 period 1Week 2 period 1Week 3 period 1Week 4 period 1Baseline period 2Week 1 period 2Week 2 period 2Week 3 period 2Week 4 period 2
Cannabidiol, Then Placebo90.185.395.393.095.6105.4108.4104.7105.2107.2
Placebo, Then Cannabidiol85.187.574.989.989.087.388.590.786.395.6

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Number of Participants Considered Treatment Responders During the OLE Treatment Period

Treatment responders were defined as those participants with a ≥50% reduction from baseline in TSC-associated seizure frequency, during the treatment period, for participants who had not withdrawn from the trial during the treatment period. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that were countable. Participants who withdrew from the trial during the treatment period were considered non-responders. (NCT02544750)
Timeframe: OLE Day 1 up to 4 years

,
InterventionParticipants (Count of Participants)
≥ 50% reduction: Yes≥ 50% reduction: No
GWP42003-P (Double-blind Phase)7054
Placebo (Double-blind Phase)3639

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Number of Participants With Any TEAE, by Severity

"An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE.~Grade 1 (Mild) is defined as asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate) is defined as minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL). Grade 3 (Severe) is defined as medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL." (NCT02544750)
Timeframe: OLE Day 1 up to 4 years

,
InterventionParticipants (Count of Participants)
Mild TEAEModerate TEAESevere TEAE
GWP42003-P (Double-blind Phase)356319
Placebo (Double-blind Phase)164811

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Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period

TSC-associated seizures include: focal motor seizures without impairment of consciousness or awareness; focal seizures with impairment of consciousness or awareness; focal seizures evolving to bilateral generalized convulsive seizures and tonic-clonic, tonic, clonic or atonic seizures. A negative percent change from baseline indicates improvement. (NCT02544750)
Timeframe: OLE Day 1 up to 4 years

Interventionpercent change (Median)
GWP42003-P (Double-blind Phase)-55.66
Placebo (Double-blind Phase)-46.76

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Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period

Total seizures included all seizure types, eg. combination of TSC-associated and other seizures. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that were countable. A negative percent change from baseline indicates improvement in total seizure frequency. (NCT02544750)
Timeframe: OLE Day 1 up to 4 years

Interventionpercent change (Median)
GWP42003-P (Double-blind Phase)-55.18
Placebo (Double-blind Phase)-46.76

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Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period

"The CGIC comprised the following question to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment). The SGIC comprised the following question to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): Since you started treatment, please assess the status of your overall condition (comparing your condition now to your condition before treatment). The average CGIC and SGIC scores are being reported, with higher values indicating worse condition." (NCT02544750)
Timeframe: OLE Day 1 and up to 4 years

,
Interventionscore on a scale (Mean)
CaregiverSubjectsCombined Caregiver and Subjects
GWP42003-P (Double-blind Phase)3.24.03.2
Placebo (Double-blind Phase)3.42.73.3

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Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration)

TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that are countable. Percent change from Baseline was calculated as the (post-Baseline value minus the Baseline value) divided by the Baseline value x 100. (NCT02544763)
Timeframe: Baseline; up to Week 16

Interventionpercent change (Median)
GWP42003-P 25 mg/kg/Day-43.36
GWP42003-P 50 mg/kg/Day-36.55
Placebo-20.08

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Number of Participants With Any Severe Treatment-emergent Adverse Event (TEAE)

A TEAE was defined as an AE with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of first dose of the Open-label Extension (OLE) Phase (OLE Day 1). (NCT02544763)
Timeframe: up to approximately Week 22

InterventionParticipants (Count of Participants)
GWP42003-P 25 mg/kg/Day7
GWP42003-P 50 mg/kg/Day9
Placebo1

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Percent Change From Baseline in Total Seizures During the Treatment Period (Maintenance and Titration)

Total seizures included all seizure types combined. Percent change from Baseline was calculated as the (post-Baseline value minus the Baseline value) divided by the Baseline value x 100. (NCT02544763)
Timeframe: Baseline; up to Week 16

Interventionpercent change (Mean)
GWP42003-P 25 mg/kg/Day-34.71
GWP42003-P 50 mg/kg/Day-35.14
Placebo-19.63

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Change From Baseline in the Caregiver Global Impression of Change (CGIC) or Participant Global Impression of Change (PGIC) Score at the Participant's Last Visit

"The combined caregiver and participant summary uses either the caregiver or participant version if only one version was completed, or the caregiver version if both caregiver and participant versions were completed. The CGIC comprised the following question, to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment). The SGIC comprised the following question, to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): Since you started treatment, please assess the status of your overall condition (comparing your condition now to your condition before treatment)." (NCT02544763)
Timeframe: Baseline; up to Week 16

,,
Interventionunits on a scale (Mean)
CaregiverCombined Caregiver and ParticipantParticipant
GWP42003-P 25 mg/kg/Day3.03.03.3
GWP42003-P 50 mg/kg/Day3.13.24.5
Placebo3.53.52.8

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Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration)

Treatment responders are defined as those participants with a ≥ 50% reduction in TSC-associated seizure frequency. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that are countable. Participants who withdrew from the trial during the treatment period are considered non-responders. (NCT02544763)
Timeframe: Baseline; up to Week 16

,,
InterventionParticipants (Count of Participants)
RespondersNon-responders
GWP42003-P 25 mg/kg/Day2748
GWP42003-P 50 mg/kg/Day2944
Placebo1759

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Part A: Time to Complete Responder Relapse

Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14. (NCT02551731)
Timeframe: Day 14

InterventionDays (Number)
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BIDNA

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Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs)

(NCT02551731)
Timeframe: Up to Week 64

InterventionPercentage of participants (Number)
AEsTEAEsSAEs
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID44.433.30.0

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Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14

(NCT02551731)
Timeframe: Baseline, Day 14

InterventionNumber of spasms (Median)
Visit 1(Baseline)Visit 3 (Day 14)
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID0.09.0

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Part A: Percentage of Participants With Absence of Infantile Spasms at Day 14

(NCT02551731)
Timeframe: Day 14

InterventionPercentage of participants (Number)
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID42.9

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Part A: Parent Impression of Efficacy and Tolerability of Study Drug

Parent impression of efficacy and tolerability, as measured by Clinical Global Impression-Global Improvement Scale (CGI-I), was summarized by visit and status of response (Complete/Partial and No Response) at Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. The CGI-I was also analyzed in a continuous scale, as follows: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse (NCT02551731)
Timeframe: Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study.

InterventionUnits on a scale (Mean)
Visit 3 (Day 14)Visit 4 (Week 4)Visit 5 (Week 8)Visit 6 (Week 10)Early Discontinuation/ End of Study
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID3.01.01.01.04.0

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Part A: Percentage of Complete Responders With Relapse

Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14. (NCT02551731)
Timeframe: Day 14

InterventionPercentage of participants (Number)
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID0

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Part A: Percentage of Participants Who Are Considered Complete Responders at Day 14

Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-electroencephalogram (EEG) at Day 14. (NCT02551731)
Timeframe: Day 14

InterventionPercentage of participants (Number)
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID14.3

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Part A: Percentage of Participants With a Partial Response to Treatment

Partial response was defined as a substantive change in background EEG or reduction in spasms on video EEG obtained at Day 14. (NCT02551731)
Timeframe: Day 14

InterventionPercentage of participants (Number)
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID0

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Part A: Percentage of Participants With Absence of Hypsarrhythmia at Day 14

(NCT02551731)
Timeframe: Day 14

InterventionPercentage of participants (Number)
Cannabidiol Oral Solution: 20 or 40 mg/kg/Day BID42.9

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Number Of Participants Who Experienced Severe OLE-Emergent AEs

"An OLE-emergent AE was defined as an AE with an onset date after the first dose of IMP in the OLE phase of the study. The number of participants who experienced 1 or more severe OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 [± 3] days following the last dose of IMP) is presented.~A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module." (NCT02564952)
Timeframe: Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)

InterventionParticipants (Count of Participants)
GWP42003-P4

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Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33

"The Cmax of CLB and its primary metabolite N-desmethylclobazam (N-CLB) was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose." (NCT02565108)
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33

,
Interventionng/mL (Geometric Mean)
Cmax: CLB Day 1Cmax: CLB Day 33Cmax: N-CLB Day 1Cmax: N-CLB Day 33Cmax: CLB Dose-normalized Day 1Cmax: CLB Dose-normalized Day 33Cmax: N-CLB Dose-normalized Day 1Cmax: N-CLB Dose-normalized Day 33
GWP42003-P 20 mg/kg/Day Dose3303292060457019.319.2121267
Placebo4404611130132022.023.156.666.1

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PK: Geometric Mean Ratios Of CLB And N-CLB For AUCtau On Day 33 Compared With Day 1

The Day 33 compared to Day 1 geometric mean ratios of CLB and N-CLB were calculated for AUCtau to look for evidence of drug-drug interactions between GWP42003-P/Placebo and CLB and between GWP42003-P/Placebo and N-CLB. A standard 90% CI approach for the between time point ratios of geometric means of AUCtau was carried out on a logarithmic scale using a linear mixed effect model. The no-effect boundary was set between 0.5 and 2.0, and if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0], a lack of meaningful effect was declared. Estimates were back transformed to provide summaries on the original scale. The model included a fixed effect term for PK assessment period. An unstructured covariance matrix was used. Kenward and Roger's method was used to calculate the denominator degrees of freedom for the fixed effects. (NCT02565108)
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33

,
InterventionRatio (Number)
Geometric Mean Ratio of CLB, AUCtauGeometric Mean Ratio of N-CLB, AUCtau
GWP42003-P 20 mg/kg/Day Dose1.062.64
Placebo0.9961.00

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PK: Time To The Maximum Plasma Concentration (Tmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33

"The tmax of CLB and its primary metabolite N-CLB was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose." (NCT02565108)
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33

,
Interventionh (Median)
tmax: CLB Day 1tmax: CLB Day 33tmax: N-CLB Day 1tmax: N-CLB Day 33
GWP42003-P 20 mg/kg/Day Dose1.001.861.503.03
Placebo1.171.582.001.00

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PK: Geometric Mean Ratios Of CLB And N-CLB For Cmax On Day 33 Compared With Day 1

The Day 33 compared to Day 1 geometric mean ratios of CLB and N-CLB were calculated for Cmax to look for evidence of drug-drug interactions between GWP42003-P/Placebo and CLB and between GWP42003-P/Placebo and N-CLB. A standard 90% confidence interval (CI) approach for the between time point ratios of geometric means of Cmax was carried out on a logarithmic scale using a linear mixed effect model. The no-effect boundary was set between 0.5 and 2.0, and if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0], a lack of meaningful effect was declared. Estimates were back transformed to provide summaries on the original scale. The model included a fixed effect term for PK assessment period. An unstructured covariance matrix was used. Kenward and Roger's method was used to calculate the denominator degrees of freedom for the fixed effects. (NCT02565108)
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33

,
InterventionRatio (Number)
Geometric Mean Ratio of CLB, CmaxGeometric Mean Ratio of N-CLB, Cmax
GWP42003-P 20 mg/kg/Day Dose0.9972.22
Placebo1.051.17

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PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33

"The AUCtau of CLB and its primary metabolite N-CLB was measured on Day 1 (before first GWP42003-P dose; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose." (NCT02565108)
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33

,
Interventionh*ng/mL (Geometric Mean)
AUCtau: CLB Day 1AUCtau: CLB Day 33AUCtau: N-CLB Day 1AUCtau: N-CLB Day 33AUCtau: CLB Dose-normalized Day 1AUCtau: CLB Dose-normalized Day 33AUCtau: N-CLB Dose-normalized Day 1AUCtau: N-CLB Dose-normalized Day 33
GWP42003-P 20 mg/kg/Day Dose26902840183004840015716610702830
Placebo332033101140011500166165571573

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Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)

"A TEAE was defined as an adverse event with an onset date on or after the first dose of IMP. If an adverse event (AE) had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced 1 or more severe TEAEs after screening up to Day 71.~A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module." (NCT02565108)
Timeframe: Postdose on Day 2 up to Safety follow-up (Day 71)

InterventionParticipants (Count of Participants)
GWP42003-P 20 mg/kg/Day Dose1
Placebo0

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Number of Participants With Change in Laboratory Tests Considered by Managing Neurologists as Clinically Significant.

During study clinic visits, participants received laboratory testing to assess for side effects and toxicity. Data was recorded and stored in the UAB RedCap System. Laboratory testing included Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP; included Liver Function Tests (LFTs) mainly looking at alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), Urine Analysis (UA), and Antiepileptic Drug (AED) levels. Clinically significant was determined by using the Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events categorized as a grade 3 or above were considered clinically significant. Adverse events grade 4 or above were considered severe adverse events. (NCT02695537)
Timeframe: For 1 Year following Enrollment

InterventionParticipants (Count of Participants)
CBC: White Blood Cell (WBC) CountCBC: Red Blood Cell (RBC) CountCBC: HemoglobinCBC: HematocritCBC: PlateletCBC: Absolute (ABS) NeutrophilsCBC: ABS LymphocytesCBC: ABS MonocytesCBC: NeutrophilsCBC: LymphocytesCMP: Serum CreatinineCMP: Creatinine ClearanceCMP: ALT (SGPT)CMP: AST (SGOT)CMP: Total BilirubinCMP: Direct BilirubinCMP: Blood Urea Nitrogen (BUN)CMP: AlbuminCMP: Alkaline PhosphateCMP: GlucoseCMP: CalciumCMP: Carbon DioxideCMP: ChlorideCMP: PotassiumCMP: SodiumUA: Specific GravityUA: PHUA: Leukocyte EsteraseUA: NitriteUA: ProteinUA: GlucoseUA: KetonesUA: UrubilinogenUA: BilirubinUA: BloodAED: Phenobarbital LevelAED: Primidone LevelAED: Klonopin LevelAED: Clobazam LevelAED: Desmethylclobazam LevelAED: Lorazepam LevelAED: Phenytoin LevelAED: Carbamazepine LevelAED: Clorazepate LevelAED: Valproate LevelAED: Felbamate LevelAED: Gabapentin LevelAED: Lamotrigine LevelAED: Levetiracetam LevelAED: Oxcarbazepine LevelAED: Ethosuximide LevelAED: Tiagabine LevelAED: Topiramate LevelAED: Vigabatrin LevelAED: Zonisamide LevelAED: Eslicarbazepine LevelAED: Ezogabine LevelAED: Pregabalin LevelAED: Perampanel LevelAED: Rufinamide LevelAED: Brivaracetam LevelAED: Lacosamide LevelAED: Diazepam Level
Epidiolex412232111000118001010000120027321527214181000000000100001000000000000

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Number of Participants With Severe Adverse Events (Increase in Seizure Frequency by More Than 100% Leading to Emergency Room Visit or Hospitalization).

Severe adverse events (SAEs) were defined as increase in seizure frequency by more than 100% leading to emergency room visit or hospitalization. During study clinic and phone visits, adverse and severe adverse event monitoring and reporting were assessed among all participants. Data was recorded and stored in the UAB RedCap System. (NCT02695537)
Timeframe: For 1 Year following Enrollment

InterventionParticipants (Count of Participants)
Epidiolex0

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Change in Seizure Frequency as Measured in Total Number of Seizures Per Month.

Participants were given seizure diary logs and dairy data collection was done at study clinic visits. Data was recorded and stored in the UAB RedCap System. The analysis plan was to assess the pattern of change in seizure frequency over time, relative to baseline, following CBD exposure. Since the baseline measure was reported at the time of screening, there was some tendency to overestimate the frequency of seizures in the historically reported interval. This was examined by comparing the initial study visits improvement versus the pattern of control over time, and was assessed using graphic techniques and summary statistics. (NCT02695537)
Timeframe: For 1 Year following Enrollment

Interventionnumber of seizures/month (Geometric Least Squares Mean)
Month 1 vs BaselineMonth 2 vs BaselineMonth 3 vs BaselineMonth 4 vs BaselineMonth 5 vs BaselineMonth 6 vs BaselineMonth 7 vs BaselineMonth 8 vs BaselineMonth 9 vs BaselineMonth 10 vs BaselineMonth 11 vs BaselineMonth 12 vs Baseline
Epidiolex0.630.440.380.380.40.410.420.410.410.390.380.36

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Change in Seizure Severity Measured by the Chalfont Seizure Severity Scale (Duncan & Sander, 1991, JNNP).

Seizure severity was collected during study clinic and phone visits using the Chalfont Seizure Severity Scale (CSSS) (Duncan & Sander, 1991, JNNP) through verbal reporting. The CSSS measured components of seizures most disturbing or disruptive to the participants. The total scores for a given seizure type was its severity score. High scores indicated high severity of the seizures (no fixed maximum value), while a score of zero indicated low severity. Scores were recorded and stored in the UAB RedCap System. The analysis plan was to assess the pattern of change in seizure severity scores over time, relative to baseline, following CBD exposure. Since the baseline measure was reported at the time of screening, there was some tendency to overestimate the severity of seizures in the historically reported interval. This was examined by comparing the initial study visits improvement versus the pattern of control over time, and was assessed using graphic techniques and summary statistics. (NCT02695537)
Timeframe: For 1 Year following Enrollment

Interventionscores on a scale (Geometric Least Squares Mean)
Month 1 vs BaselineMonth 2 vs BaselineMonth 3 vs BaselineMonth 4 vs BaselineMonth 5 vs BaselineMonth 6 vs BaselineMonth 7 vs BaselineMonth 8 vs BaselineMonth 9 vs BaselineMonth 10 vs BaselineMonth 11 vs BaselineMonth 12 vs Baseline
Epidiolex0.660.470.370.350.360.40.430.440.450.460.460.46

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Number of Participants With Change in Resting Blood Pressure or Heart Rate by 25% if Considered Significant by Managing Neurologist.

During study clinic visits, participant vital signs, including blood pressure and heart rate, were collected. Data was recorded and stored in the UAB RedCap System. Clinically significant was determined by using the Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events categorized as a grade 3 or above were considered clinically significant. Adverse events grade 4 or above were considered severe adverse events. (NCT02695537)
Timeframe: For 1 Year following Enrollment

InterventionParticipants (Count of Participants)
Blood PressureHeart Rate
Epidiolex00

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Change in Seizure Frequency as Measured in Total Number of Seizures Per Month.

Participants were given seizure diary logs and dairy data collection was done at study clinic visits. Data was recorded and stored in the UAB RedCap System. The analysis plan was to assess the pattern of change in seizure frequency over time, relative to baseline, following CBD exposure. Since the baseline measure was reported at the time of screening, there was some tendency to overestimate the frequency of seizures in the historically reported interval. This was examined by comparing the initial study visits improvement versus the pattern of control over time, and was assessed using graphic techniques and summary statistics. (NCT02700412)
Timeframe: For 1 Year following Enrollment

Interventionnumber of seizures/month (Geometric Least Squares Mean)
Month 1 vs BaselineMonth 2 vs BaselineMonth 3 vs BaselineMonth 4 vs BaselineMonth 5 vs BaselineMonth 6 vs BaselineMonth 7 vs BaselineMonth 8 vs BaselineMonth 9 vs BaselineMonth 10 vs BaselineMonth 11 vs BaselineMonth 12 vs Baseline
Epidiolex0.730.560.470.440.440.470.480.490.490.480.480.47

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Change in Seizure Severity Measured by the Chalfont Seizure Severity Scale (Duncan & Sander, 1991, JNNP).

Seizure severity was collected during study clinic and phone visits using the Chalfont Seizure Severity Scale (CSSS) (Duncan & Sander, 1991, JNNP) through verbal reporting. The CSSS measured components of seizures most disturbing or disruptive to the participants. The total scores for a given seizure type was its severity score. High scores indicated high severity of the seizures (no fixed maximum value), while a score of zero indicated low severity. Scores were recorded and stored in the UAB RedCap System. The analysis plan was to assess the pattern of change in seizure severity scores over time, relative to baseline, following CBD exposure. Since the baseline measure was reported at the time of screening, there was some tendency to overestimate the severity of seizures in the historically reported interval. This was examined by comparing the initial study visits improvement versus the pattern of control over time, and was assessed using graphic techniques and summary statistics. (NCT02700412)
Timeframe: For 1 Year following Enrollment

Interventionscores on a scale (Geometric Least Squares Mean)
Month 1 vs BaselineMonth 2 vs BaselineMonth 3 vs BaselineMonth 4 vs BaselineMonth 5 vs BaselineMonth 6 vs BaselineMonth 7 vs BaselineMonth 8 vs BaselineMonth 9 vs BaselineMonth 10 vs BaselineMonth 11 vs BaselineMonth 12 vs Baseline
Epidiolex0.530.320.230.220.240.280.290.280.250.220.190.16

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Number of Participants With Change in Resting Blood Pressure or Heart Rate by 25% if Considered Significant by Managing Neurologist.

During study clinic visits, participant vital signs, including blood pressure and heart rate, were collected. Data was recorded and stored in the UAB RedCap System. Clinically significant was determined by using the Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events categorized as a grade 3 or above were considered clinically significant. Adverse events grade 4 or above were considered severe adverse events. (NCT02700412)
Timeframe: For 1 Year following Enrollment

InterventionParticipants (Count of Participants)
Blood PressureHeart Rate
Epidiolex00

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Number of Participants With Severe Adverse Events (SAEs) (Increase in Seizure Frequency by More Than 100% Leading to Emergency Room Visit or Hospitalization).

Severe adverse events (SAEs) were defined as increase in seizure frequency by more than 100% leading to emergency room visit or hospitalization. During study clinic and phone visits, adverse and severe adverse event monitoring and reporting were assessed among all participants. Data was recorded and stored in the UAB RedCap System. (NCT02700412)
Timeframe: For 1 Year following Enrollment

InterventionParticipants (Count of Participants)
Epidiolex0

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Number of Participants With Change in Laboratory Tests Considered by Managing Neurologists as Clinically Significant.

During study clinic visits, participants received laboratory testing to assess for side effects and toxicity. Data was recorded and stored in the UAB RedCap System. Laboratory testing included Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP; included Liver Function Tests (LFTs) mainly looking at alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), Urine Analysis (UA), and Antiepileptic Drug (AED) levels. Clinically significant was determined by using the Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events categorized as a grade 3 or above were considered clinically significant. Adverse events grade 4 or above were considered severe adverse events. (NCT02700412)
Timeframe: For 1 Year following Enrollment

InterventionParticipants (Count of Participants)
CBC: White Blood Cell (WBC) CountCBC: Red Blood Cell (RBC) CountCBC: HemoglobinCBC: HematocritCBC: PlateletCBC: Absolute (ABS) NeutrophilsCBC: ABS LymphocytesCBC: ABS MonocytesCBC: NeutrophilsCBC: LymphocytesCMP: Serum CreatinineCMP: Creatinine ClearanceCMP: ALT (SGPT)CMP: AST (SGOT)CMP: Total BilirubinCMP: Direct BilirubinCMP: Blood Urea Nitrogen (BUN)CMP: AlbuminCMP: Alkaline PhosphateCMP: GlucoseCMP: CalciumCMP: Carbon DioxideCMP: ChlorideCMP: PotassiumCMP: SodiumUA: Specific GravityUA: PHUA: Leukocyte EsteraseUA: NitriteUA: ProteinUA: GlucoseUA: KetonesUA: UrobilinogenUA: BilirubinUA: BloodAED: Phenobarbital LevelAED: Primidone LevelAED: Klonopin LevelAED: Clobazam LevelAED: Desmethylclobazam LevelAED: Lorazepam LevelAED: Phenytoin LevelAED: Carbamazepine LevelAED: Clorazepate LevelAED: Valproate LevelAED: Felbamate LevelAED: Gabapentin LevelAED: Lamotrigine LevelAED: Levetiracetam LevelAED: Oxcarbazepine LevelAED: Ethosuximide LevelAED: Tiagabine LevelAED: Topiramate LevelAED: Vigabatrin LevelAED: Zonisamide LevelAED: Eslicarbazepine LevelAED: Ezogabine LevelAED: Pregabalin LevelAED: Perampanel LevelAED: Rufinamide LevelAED: Brivaracetam LevelAED: Lacosamide LevelAED: Diazepam Level
Epidiolex0000200000003200002000001004263251911220000000000000000000000000000

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Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test

"Time to first feel pain (Pain threshold measured in seconds) during the Cold Pressor Test and withdraw the hand from the cold water (Pain Tolerance measured in seconds). Changes in threshold from baseline were averaged across study sessions for each CBD dose." (NCT02751359)
Timeframe: Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose

,,,
InterventionSeconds (Mean)
ThresholdTolerance
Active CBD 200 mg9.75.1
Active CBD 400 mg2.215.3
Active CBD 800 mg2.1-0.6
Placebo1.29.6

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Baseline CAPS-5 Total Severity Score

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance), and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. (NCT02759185)
Timeframe: Baseline (3 weeks after randomization)

Interventionscore on a scale (Mean)
High THC Cannabis36.6
High CBD Cannabis36.8
THC/CBD Cannabis38.0
Placebo Cannabis37.3

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Actigraph Change in Sleep Efficiency

"Daily sleep measures were collected using the Actigraph Watch at baseline and throughout the study period. Data were processed using the Actigraph Software according to the User Manual to measure sleep efficiency, which is defined as the proportion of the estimated sleep periods spent asleep. Change in sleep efficiency was calculated and compared across the four treatment groups to assess whether there was any improvement or worsening in sleep efficiency before and after the 4-week treatment period. Other measures included number of days data were collected and average duration in minutes of time that were excluded and not recorded. Daily data were aggregated to analyze participants' average weekly sleep patterns." (NCT02759185)
Timeframe: Change in sleep efficiency from baseline to end of 4-week treatment period (visit 6)

Interventionpercentage of total sleep time (Mean)
High CBD Cannabis0.17
High THC Cannabis6.83
THC/CBD Cannabis1.80
Placebo Cannabis-0.28

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Change in Inventory of Depression and Anxiety (IDAS) Social Anxiety Total Scores From Baseline to Stage 1 Primary Endpoint

The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess social anxiety are summed and range from 5 to 25 with higher scores indicating greater anxiety symptoms. (NCT02759185)
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)

Interventionscore on a scale (Mean)
High THC Cannabis-3.7
High CBD Cannabis-2.7
THC/CBD Cannabis-2.2
Placebo Cannabis-2.4

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Stage 1 Primary Endpoint CAPS-5 Total Severity Scores (Visit 5)

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. (NCT02759185)
Timeframe: Visit 5 (between end of week 3 and start of week 4) of Stage 1

Interventionscore on a scale (Mean)
High THC Cannabis20.5
High CBD Cannabis28.1
THC/CBD Cannabis29.6
Placebo Cannabis24.2

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Change in PTSD Checklist (PCL-5) From Baseline to Stage 1 Primary Endpoint

The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms. Participants indicate how much distress they have experienced due to various PTSD symptoms on a five-point Likert-type scale (0=not at all, 4=extremely). The total PCL-5 score (a sum of all 20 items) ranges from 0 to 80, with higher scores indicating greater symptom severity. (NCT02759185)
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)

Interventionscore on a scale (Mean)
High THC Cannabis-23.5
High CBD Cannabis-12.1
THC/CBD Cannabis-16.4
Placebo Cannabis-14.6

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Change in Inventory of Psychosocial Functioning (IPF) From Baseline to Stage 1 Primary Endpoint

The Inventory of Psychosocial Functioning (IPF) is an 80-item measure that was developed for use among individuals with PTSD. It assesses current psychosocial functioning across seven domains: romantic relationships, family, work, friendships, parenting, education, and self-care. Items are scored on a 0 (never) to 6 (always) scale. Summation of scores across domains yields a total score for psychosocial functioning, with higher scores indicating greater functional impairment. (NCT02759185)
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)

Interventionscore on a scale (Mean)
High THC Cannabis1.2
High CBD Cannabis-1.2
THC/CBD Cannabis4.1
Placebo Cannabis-0.2

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Change in Inventory of Depression and Anxiety (IDAS) General Depression Total Scores From Baseline to Stage 1 Primary Endpoint

The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess general depression are summed and range from 20 to 100 with higher scores indicating greater depressive symptoms. (NCT02759185)
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)

Interventionscore on a scale (Mean)
High THC Cannabis-16.1
High CBD Cannabis-11.4
THC/CBD Cannabis-13.4
Placebo Cannabis-8.3

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Change in Insomnia Severity Index (ISI) Scores From Baseline to Stage 1 Primary Endpoint

The Insomnia Severity Index (ISI) is a brief self-reported measure of insomnia. It consists of seven questions, with responses made on a five-point Likert scale. Three items address difficulty at sleep onset, maintaining sleep, and early waking, and four questions address perceived quality of sleep and effects of sleep difficulties on daily function. Questions are summed into a total score that ranges from 0 to 28 and can be interpreted as ranging from no signs of insomnia to severe insomnia. Higher scores indicate more severe insomnia. (NCT02759185)
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)

Interventionscore on a scale (Mean)
High THC Cannabis-8.8
High CBD Cannabis-5.9
THC/CBD Cannabis-6.6
Placebo Cannabis-6.1

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Change in CAPS-5 Total Severity Scores From Baseline to Stage 1 Primary Endpoint (Visit 5)

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. (NCT02759185)
Timeframe: Baseline (3 weeks after randomization) to Primary Endpoint (Visit 5, between end of week 3 and start of week 4)

Interventionscore on a scale (Mean)
High THC Cannabis-15.2
High CBD Cannabis-8.4
THC/CBD Cannabis-8.5
Placebo Cannabis-13.1

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Number of Participants Had Changes in Orthostatic Blood Pressure

Orthostatic blood pressure will be monitored at each study visit. (NCT02818777)
Timeframe: Baseline and 5 weeks

InterventionParticipants (Count of Participants)
Cannabidiol0

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Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance

Assessing the proportion of subjects that drop out of the study due to study drug intolerance. (NCT02818777)
Timeframe: Baseline and 5 weeks

InterventionParticipants (Count of Participants)
Cannabidiol3

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Change in Anxiety Short Form

This includes 8 items that assess severity of anxiety. Scores range 8-40. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol0.33

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Number of Participants Had Changes in Laboratory Values

Laboratory tests (hematology, serum chemistry, and urinalysis) will be evaluated at each study visit. (NCT02818777)
Timeframe: Baseline and 5 weeks

InterventionParticipants (Count of Participants)
Cannabidiol5

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Number of Participants Had Changes in Physical Exam

A physical exam will be performed at each study visit. (NCT02818777)
Timeframe: Baseline and 5 weeks

InterventionParticipants (Count of Participants)
Cannabidiol0

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Change From Baseline of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)

"10-item, patient self-rating instrument assessing the subject's sleep behavior with short questions that have to be answered by either yes or no. Scores range 0-13. Higher values represent a worse outcome." (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-0.7

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Change in Depression Short Form

This includes 8 items that assess severity of depression. Score range 8-40. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-0.85

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Change in Emotional and Behavioral Dyscontrol Short Form

8 items that assess severity of emotional and behavioral dyscontrol. Scores range 8-40. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-4.69

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Change in Fatigue Severity Scale

A self-report 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. Scores range 9-63. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-0.5

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Change in International Restless Legs Syndrome Study Group Rating Scale for Restless

This encompasses a ten-question instrument for measuring severity of restless legs syndrome (RLS). Score range 0-40. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-1.2

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Change in MDS-UPDRS Tremor Score (Total of Items 3.17 and 3.18) in the ON State

Sum of items 3.17 and 3.18 of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates the rest tremor amplitude (3.17, score range 0-20) and constancy of rest tremor (3.18 score range 0-4). The sum scores of 3.17 and 3.18 range 0-24. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-0.4

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Change in Montreal Cognitive Assessment (MoCA)

MoCA - is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual -constructional skills, conceptual thinking, calculation. Scores range 0-30. Higher values represent a better outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol1.0

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Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score

There are four parts: Part I (Non-motor experiences of daily living, scores range 0-52), Part II (motor experiences of daily living, scores range 0-52), Part III (motor examination, scores range 0-132) and Part IV (motor complications scores range 0-24). Subscales are summed to a total score, ranging 0-260. Higher scores mean a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-7.70

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Change in Neuropsychiatric Inventory (NPI)

Assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders. It has proven to be sensitive to change and has been employed to capture treatment related behavioral.Total NPI scores range 0-120. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-0.125

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Change in Pain Severity Form

This will assess severity of pain. Scores range 3-15. Higher scores represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-1.86

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Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)

To measure severity of symptoms and support a diagnosis of impulse control disorders and related disorders in PD. Total QUIP-RS scores were summed by 6 subscores (gambling 0-16, Sex 0-16, Buying 0-16, Eating 0-16, Hobbyism-punding 0-32, and PD Medication use 0-16), range 0-112. Higher scores represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol0

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Change in Scales for Outcomes in Parkinson's Disease (SCOPA)-Sleep-night Time Sleep

A valid, reliable, short scale that is used to evaluate night time sleep problems in PD. Scores range 0-18. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol-2.80

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Change in Unified Dyskinesia Rating Scale (UDysRS)

To evaluate involuntary movements often associated with treated Parkinson's disease. Total UDysRS scores is the sum of historical sub-scores (0-60) and objective sub-score (0-44). Total scores range 0-104. Higher values represent a worse outcome. (NCT02818777)
Timeframe: Baseline and 5 weeks

Interventionscore on a scale (Mean)
Cannabidiol1.0

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Number of Participants Had Changes in EKG

EKG will be performed at each study visit. (NCT02818777)
Timeframe: Baseline and 5 weeks

InterventionParticipants (Count of Participants)
Cannabidiol0

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Change From Baseline In Total Body Weight

Total body weight refers to participants' weight throughout the study. The change from baseline was calculated from two time points as the value at the later time point minus the value at the earlier time point: value at Week 13 minus value at Baseline. (NCT02844933)
Timeframe: Baseline, Week 13

,
Interventionkg (Median)
BaselineWeek 13Change From Baseline at Week 13
Cannabidiol88.3587.6-1.05
Placebo56.759.51.3

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Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

"The HQ-CT measures hyperphagia by Prader-Willi syndrome (PWS)-specialized clinicians. The HQ-CT generates a score ranging from 0 to 36, where a higher score represents more severe abnormal food related behaviors.~The change from baseline was calculated from two time points as the value at the later time point minus the value at the earlier time point: value at Week 13 minus value at Baseline." (NCT02844933)
Timeframe: Baseline, Week 13

,
Interventionscore on a scale (Median)
BaselineWeek 13Change from Baseline at Week 13
Cannabidiol2314-4.5
Placebo2216-2

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Positivity Ratings of Social Images

Using the International Affective Picture System (IAPS; Lang et al. 1999), participants viewed standardized positive, negative and neutral pictures from the IAPS. The negative and positive images were matched on degree of valence and arousal. An Evaluative Space Grid rating followed each picture to collect subjective reactions. Ratings are on a 9-pt scale. The range of the scale is from 1 to 9 (Min score 1, max score 9). The total score is reported. Higher numbers represent more positive valence or greater arousal. Drug treatment: within-subjects; every participant received all drug doses, counter-balanced. (NCT02902081)
Timeframe: End of study (time 0 and approximately 4 weeks later), week 4 reported.

,,,
Interventionscore on a scale (Mean)
Positive ImageNegative ImageNeutral Image
300 mg Cannabidiol1.680.480.99
600 mg Cannabidiol1.860.411.08
900 mg Cannabidiol1.930.351.13
Placebo1.960.471.12

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Number of Responders

A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Testing for responders was conducted by VEEG for at least 8 hours and up to 24 hours. (NCT02953548)
Timeframe: Baseline to Day 15

Interventionresponders (Number)
Cohort 1: GWP42003-P OS0
Cohort 2: GWP42003-P OS0

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Number of Participants With Resolution of Hypsarrhythmia

Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. (NCT02953548)
Timeframe: Day 15

InterventionParticipants (Count of Participants)
GWP42003-P OS0

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Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)

TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP. (NCT02953548)
Timeframe: From signing of informed consent up to Day 15

InterventionParticipants (Count of Participants)
GWP42003-P OS6

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Number of Participants Free of Clinical Spasms

Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours. (NCT02953548)
Timeframe: Day 15

InterventionParticipants (Count of Participants)
GWP42003-P OS0

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Percentage of Participants Free of Clinical Spasms

Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours. (NCT02953548)
Timeframe: Day 15

Interventionpercentage of participants (Number)
GWP42003-P OS0

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Percentage of Participants With Resolution of Hypsarrhythmia

Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. (NCT02953548)
Timeframe: Day 15

Interventionpercentage of participants (Number)
GWP42003-P OS0

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Percentage of Responders

A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Testing for responders was conducted by VEEG for at least 8 hours and up to 24 hours. (NCT02953548)
Timeframe: Baseline to Day 15

Interventionresponders (Number)
Cohort 1: GWP42003-P OS0
Cohort 2: GWP42003-P OS0

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Caregiver Clinical Global Impression of Change (CGIC)

The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale from 1 (very much improved) to 7 (very much worse). (NCT02953548)
Timeframe: Day 15

Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedSlightly ImprovedNo ChangeSlightly WorseMuch WorseVery Much WorseNot Done
GWP42003-P OS10710000

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Number of Participant With Any Clinically Relevant Urinalysis Parameter Value

Clinical relevance was determined by the investigator. (NCT02953548)
Timeframe: Day 4 and Day 15

InterventionParticipants (Count of Participants)
Day 4Day 15
GWP42003-P OS00

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Number of Participants Experiencing Spasms and Seizures by Subtype

Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizures included: clonic, tonic-clonic, myoclonic, focal, and absence. (NCT02953548)
Timeframe: Day 4 and Day 15

InterventionParticipants (Count of Participants)
Day 4, ClonicDay 4, Tonic-ClonicDay 4, AtonicDay 4, MyoclonicDay 4, FocalDay 4, AbsenceDay 4, Not DoneDay 15, ClonicDay 15, Tonic-ClonicDay 15, AtonicDay 15, MyoclonicDay 15, FocalDay 15, AbsenceDay 15, Not Done
GWP42003-P OS01001000000200

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Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value

(NCT02953548)
Timeframe: Day 4 and Day 15

InterventionParticipants (Count of Participants)
Day 4, LowDay 4, HighDay 15, LowDay 15, High
GWP42003-P OS7557

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Number of Participants With Clinically Significant Electrocardiogram Findings

Clinical significance was determined by the investigator. (NCT02953548)
Timeframe: From signing of informed consent up to Day 15

InterventionParticipants (Count of Participants)
GWP42003-P OS0

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Physician Global Impression of Change (PGIC)

The PGIC is a single-question assessment completed by the investigator. The question assesses the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale from 1 (very much improved) to 7 (very much worse). (NCT02953548)
Timeframe: Day 15

Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedSlightly ImprovedNo ChangeSlightly WorseMuch WorseVery Much WorseNot Done
GWP42003-P OS01530000

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Number of Participants With Clinically Significant Physical Examination Findings

Clinical significance was determined by the investigator. (NCT02953548)
Timeframe: From signing of informed consent up to Day 15

InterventionParticipants (Count of Participants)
GWP42003-P OS0

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Number of Participants With Clinically Significant Vital Sign Findings

Clinical significance was determined by the investigator. (NCT02953548)
Timeframe: From signing of informed consent up to Day 15

InterventionParticipants (Count of Participants)
GWP42003-P OS0

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Number of Participants With Any Low or High Hematology Laboratory Parameter Value

(NCT02953548)
Timeframe: Day 4 and Day 15

InterventionParticipants (Count of Participants)
Day 4, LowDay 4, HighDay 15, LowDay 15, High
GWP42003-P OS4413

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Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score

"The Vineland-II scores were assessed by the participant's caregiver. Caregivers were asked to score questions in the following categories: the participant's communication, daily living, physical activity, problem behaviors, and social skills and relationships. Scoring was slightly different for each section, but generally ranged from usually (2) to never (0). The total score is calculated as the sum of standard scores from the domains and converted into the adaptive behavior composite score (ranging from 20 to 160). Higher scores represent greater levels of functioning, and lower scores represent lower levels of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value." (NCT02954887)
Timeframe: Baseline (Day 1 of Pilot Study); Day 211, Day 379

Interventionscore on a scale (Mean)
Baseline, Day 1 of Pilot StudyDay 211 of OLEDay 379 of OLE
GWP42003-P OS33.66.3-5.4

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Number of Participants Free of Clinical Spasms

Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours. (NCT02954887)
Timeframe: Days 29, 43, 127, 211, 295, and 379

InterventionParticipants (Count of Participants)
Day 29Day 43Day 127Day 211Day 295Day 379
GWP42003-P OS121113

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Number of Participants With a Resolution of Hypsarrhythmia

Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. (NCT02954887)
Timeframe: Days 29, 43, 127, 211, 295, and 379

InterventionParticipants (Count of Participants)
Day 29Day 43Day 127Day 211Day 295Day 379
GWP42003-P OS101013

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Number of Participants With Any Clinically Relevant Urinalysis Parameter Value

Clinical relevance was determined by the investigator. (NCT02954887)
Timeframe: Days 19, 29, 43, 71, 127, 211, 295, 379, and 389

InterventionParticipants (Count of Participants)
Day 19Day 29Day 43Day 71Day 127Day 211Day 295Day 379Day 389
GWP42003-P OS000100000

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Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value

(NCT02954887)
Timeframe: Days 19, 29, 43, 71, 127, 211, 295, 379, and 389

InterventionParticipants (Count of Participants)
Day 19, LowDay 19, HighDay 29, LowDay 29, HighDay 43, LowDay 43, HighDay 71, LowDay 71, HighDay 127, LowDay 127, HighDay 211, LowDay 211, HighDay 295, LowDay 295, HighDay 379, LowDay 379, HighDay 389, LowDay 389, High
GWP42003-P OS676645244323235732

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Number of Participants With Any Low or High Hematology Laboratory Parameter Value

(NCT02954887)
Timeframe: Days 19, 29, 43, 71, 127, 211, 295, 379, and 389

InterventionParticipants (Count of Participants)
Day 19, LowDay 19, HighDay 29, LowDay 29, HighDay 43, LowDay 43, HighDay 71, LowDay 71, HighDay 127, LowDay 127, HighDay 211, LowDay 211, HighDay 295, LowDay 295, HighDay 379, LowDay 379, HighDay 389, LowDay 389, High
GWP42003-P OS343412131312204414

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Number of Responders

A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. (NCT02954887)
Timeframe: Days 29, 43, 127, 211, 295, and 379

InterventionParticipants (Count of Participants)
Day 29Day 43Day 127Day 211Day 295Day 379
GWP42003-P OS100013

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Percentage of Participants Free of Clinical Spasms

Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours. (NCT02954887)
Timeframe: Days 29, 43, 127, 211, 295, and 379

Interventionpercentage of participants (Number)
Day 29Day 43Day 127Day 211Day 295Day 379
GWP42003-P OS11.122.211.111.111.133.3

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Percentage of Participants With a Resolution of Hypsarrhythmia

Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. (NCT02954887)
Timeframe: Days 29, 43, 127, 211, 295, and 379

Interventionpercentage of participants (Number)
Day 29Day 43Day 127Day 211Day 295Day 379
GWP42003-P OS11.1011.1011.133.3

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Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)

TEAEs were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP. (NCT02954887)
Timeframe: From signing of informed consent up to Day 417

InterventionParticipants (Count of Participants)
GWP42003-P OS7

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Percentage of Responders

A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. (NCT02954887)
Timeframe: Days 29, 43, 127, 211, 295, and 379

Interventionpercentage of participants (Number)
Day 29Day 43Day 127Day 211Day 295Day 379
GWP42003-P OS11.100011.133.3

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Number of Participants Experiencing Spasms and Seizures by Subtype

Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizure included, clonic, tonic-clonic, myoclonic, focal, and absence. (NCT02954887)
Timeframe: Days 19, 29, 127, 211, 295, and 379

InterventionParticipants (Count of Participants)
Day 19, ClonicDay 19, Tonic-ClonicDay 19, AtonicDay 19, MyoclonicDay 19, FocalDay 19, AbsenceDay 19, Not DoneDay 29, ClonicDay 29, Tonic-ClonicDay 29, AtonicDay 29, MyoclonicDay 29, FocalDay 29, AbsenceDay 29, Not DoneDay 127, ClonicDay 127, Tonic-ClonicDay 127, AtonicDay 127, MyoclonicDay 127, FocalDay 127, AbsenceDay 127, No DoneDay 211, ClonicDay 211, Tonic-ClonicDay 211, AtonicDay 211, MyoclonicDay 211, FocalDay 211, AbsenceDay 211, Not DoneDay 295, ClonicDay 295, Tonic-ClonicDay 295, AtonicDay 295, MyoclonicDay 295, FocalDay 295, AbsenceDay 295, Not DoneDay 379, ClonicDay 379, Tonic-ClonicDay 379, AtonicDay 379, MyoclonicDay 379, FocalDay 379, AbsenceDay 379, Not Done
GWP42003-P OS000010000001000101010010001001100101100110

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Number of Participants With Clinically Significant Electrocardiogram Findings

Clinical significance was determined by the investigator. (NCT02954887)
Timeframe: From signing of informed consent up to Day 389

InterventionParticipants (Count of Participants)
GWP42003-P OS0

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Number of Participants With Clinically Significant Physical Examination Findings

Clinical significance was determined by the investigator. (NCT02954887)
Timeframe: From signing of informed consent up to Day 389

InterventionParticipants (Count of Participants)
GWP42003-P OS0

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Number of Participants With Clinically Significant Vital Sign Findings

Clinical significance was determined by the investigator. (NCT02954887)
Timeframe: From signing of informed consent up to Day 389

InterventionParticipants (Count of Participants)
GWP42003-P OS0

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Caregiver Global Impression of Change (CGIC)

The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. (NCT02954887)
Timeframe: Baseline; Days 29, 43, 71, 127, 211, 295, and 379

Interventionparticipants (Number)
Day 29, Very Much ImprovedDay 29, Much ImprovedDay 29, Slightly ImprovedDay 29, No ChangeDay 29, Slightly WorseDay 29, Much WorseDay 29, Very Much WorseDay 29, Not DoneDay 43, Very Much ImprovedDay 43, Much ImprovedDay 43, Slightly ImprovedDay 43, No ChangeDay 43, Slightly WorseDay 43, Much WorseDay 43, Very Much WorseDay 43, Not DoneDay 71, Very Much ImprovedDay 71, Much ImprovedDay 71, Slightly ImprovedDay 71 No ChangeDay 71, Slightly WorseDay 71, Much WorseDay 71, Very Much WorseDay 71, Not DoneDay 127, Very Much ImprovedDay 127, Much ImprovedDay 127, Slightly ImprovedDay 127, No ChangeDay 127, Slightly WorseDay 127, Much WorseDay 127, Very Much WorseDay 127, Not DoneDay 211, Very Much ImprovedDay 211, Much ImprovedDay 211, Slightly ImprovedDay 211, No ChangeDay 211, Slightly WorseDay 211, Much WorseDay 211, Very Much WorseDay 211, Not DoneDay 295, Very Much ImprovedDay 295, Much ImprovedDay 295, Slightly ImprovedDay 295, No ChangeDay 295, Slightly WorseDay 295, Much WorseDay 295, Very Much WorseDay 295, Not DoneDay 379, Very Much ImprovedDay 379, Much ImprovedDay 379, Slightly ImprovedDay 379, No ChangeDay 379, Slightly WorseDay 379, Much WorseDay 379, Very Much WorseDay 379, Not Done
GWP42003-P OS11510000213000003010100022000000120000001200000021301101

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Physician Global Impression of Change (PGIC)

The PGIC is a single-question assessment completed by the investigator. The question assessed the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. (NCT02954887)
Timeframe: Baseline; Days 29, 43, 71, 127, 211, 295, and 379

Interventionparticipants (Number)
Day 29, Very Much ImprovedDay 29, Much ImprovedDay 29, Slightly ImprovedDay 29, No ChangeDay 29, Slightly WorseDay 29, Much WorseDay 29, Very Much WorseDay 29, Not DoneDay 43, Very Much ImprovedDay 43, Much ImprovedDay 43, Slightly ImprovedDay 43, No ChangeDay 43, Slightly WorseDay 43, Much WorseDay 43, Very Much WorseDay 43, Not DoneDay 71, Very Much ImprovedDay 71, Much ImprovedDay 71, Slightly ImprovedDay 71, No ChangeDay 71, Slightly WorseDay 71, Much WorseDay 71, Very Much WorseDay 71, Not DoneDay 127, Very Much ImprovedDay 127, Much ImprovedDay 127, Slightly ImprovedDay 127, No ChangeDay 127, Slightly WorseDay 127, Much WorseDay 127, Very Much WorseDay 127, Not DoneDay 211, Very Much ImprovedDay 211, Much ImprovedDay 211, Slightly ImprovedDay 211, No ChangeDay 211, Slightly WorseDay 211, Much WorseDay 211, Very Much WorseDay 211, Not DoneDay 295, Very Much ImprovedDay 295, Much ImprovedDay 295, Slightly ImprovedDay 295, No ChangeDay 295, Slightly WorseDay 295, Much WorseDay 295, Very Much WorseDay 295, Not DoneDay 379, Very Much ImprovedDay 379, Much ImprovedDay 379, Slightly ImprovedDay 379, No ChangeDay 379, Slightly WorseDay 379, Much WorseDay 379, Very Much WorseDay 379, Not Done
GWP42003-P OS11240000104100001211000012100000011100000101010001321101

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Change From Baseline in Body Weight.

A positive change indicates an increase in the average participant's weight. A negative change indicates a decrease in the average participant's weight. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT02954887)
Timeframe: Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389

Interventionkilograms (Mean)
Baseline (Day 1 of Pilot Study)Day 29, OLEDay 43, OLEDay 71, OLEDay 127, OLEDay 211, OLEDay 295, OLEDay 379, OLEDay 389, OLE
GWP42003-P OS9.920.390.751.101.251.172.101.190.98

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Change From Baseline in Head Circumference

A positive change indicates an increase in the average participant's head circumference. A negative change indicates a decrease in the average participant's head circumference. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT02954887)
Timeframe: Baseline (Day 1 of PIlot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389

Interventioncentimeters (Mean)
Baseline (Day 1 of Pilot Study)Day 29, OLEDay 43, OLEDay 71, OLEDay 127, OLEDay 211, OLEDay 295, OLEDay 379, OLEDay 389, OLE
GWP42003-P OS44.71-0.010.540.701.500.75-0.31.140.90

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Change From Baseline in Height

A positive change indicates an increase in the average participant's height. A negative change indicates a decrease in the average participant's height. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT02954887)
Timeframe: Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389

Interventioncentimeters (Mean)
Baseline (Day 1 of Pilot Study)Day 29, Open-label Extension (OLE)Day 43, OLEDay 71, OLEDay 127, OLEDay 211, OLEDay 295, OLEDay 379, OLEDay 389, OLE
GWP42003-P OS75.040.850.923.103.385.338.175.313.55

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Self-report Instruments to Measure Cannabis Use

Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback (NCT03102918)
Timeframe: During Week 6

InterventionInhalations of Cannabis Per Day (Mean)
Cannabidiol26.72
Placebo5.256

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Percentage of Very Heavy Drinking Days

Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 2

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)4
Placebo4

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Percentage of Very Heavy Drinking Days

Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 3

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)5
Placebo1

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Percentage of Very Heavy Drinking Days

Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 4

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)1
Placebo1

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Percentage of Very Heavy Drinking Days

Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 5

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)2
Placebo3

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Percentage of Very Heavy Drinking Days

Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 6

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)2
Placebo5

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Number of Participants With No Heavy Drinking Days

(NCT03248167)
Timeframe: Week 6

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)4
Placebo4

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Number of Drinks Per Day

Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. (NCT03248167)
Timeframe: Baseline

Interventiondrinks/day (Mean)
Cannabidiol (CBD 600 mg Daily)4.4885
Placebo5.3623

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Number of Drinks Per Day

Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. (NCT03248167)
Timeframe: Week 4

Interventiondrinks/day (Mean)
Cannabidiol (CBD 600 mg Daily)1.9256
Placebo2.15

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Number of Drinks Per Day

Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking. (NCT03248167)
Timeframe: Week 6

Interventiondrinks/day (Mean)
Cannabidiol (CBD 600 mg Daily)2.4881
Placebo2.8175

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Number of Participants That Are 'Present and Clear'

Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. (NCT03248167)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)17
Placebo13

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Number of Participants That Are 'Present and Clear'

Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. (NCT03248167)
Timeframe: Week 1

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)16
Placebo13

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Number of Participants That Are 'Present and Clear'

Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. (NCT03248167)
Timeframe: Week 2

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)16
Placebo13

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Number of Participants That Are 'Present and Clear'

Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. (NCT03248167)
Timeframe: Week 3

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)14
Placebo11

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Number of Participants That Are 'Present and Clear'

Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. (NCT03248167)
Timeframe: Week 4

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)12
Placebo10

[back to top]

Number of Participants That Are 'Present and Clear'

Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. (NCT03248167)
Timeframe: Week 5

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)12
Placebo9

[back to top]

Number of Participants That Are 'Present and Clear'

Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero. (NCT03248167)
Timeframe: Week 6

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)12
Placebo9

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Number of Participants With No Heavy Drinking Days

(NCT03248167)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)0
Placebo0

[back to top]

Number of Participants With No Heavy Drinking Days

(NCT03248167)
Timeframe: Week 1

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)5
Placebo4

[back to top]

Number of Participants With No Heavy Drinking Days

(NCT03248167)
Timeframe: Week 2

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)6
Placebo6

[back to top]

Number of Participants With No Heavy Drinking Days

(NCT03248167)
Timeframe: Week 3

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)9
Placebo6

[back to top]

Number of Participants With No Heavy Drinking Days

(NCT03248167)
Timeframe: Week 4

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)7
Placebo5

[back to top]

Number of Participants With No Heavy Drinking Days

(NCT03248167)
Timeframe: Week 5

InterventionParticipants (Count of Participants)
Cannabidiol (CBD 600 mg Daily)5
Placebo5

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PCL-5 Total Score

"The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: Not at all, A little bit, Moderately, Quite a bit, and Extremely. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms." (NCT03248167)
Timeframe: Baseline

Interventionscore on a scale (Mean)
Cannabidiol (CBD 600 mg Daily)42.0588
Placebo49.1538

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PCL-5 Total Score

"The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: Not at all, A little bit, Moderately, Quite a bit, and Extremely. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms." (NCT03248167)
Timeframe: Week 4

Interventionscore on a scale (Mean)
Cannabidiol (CBD 600 mg Daily)19.9231
Placebo29.9

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PCL-5 Total Score

"The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: Not at all, A little bit, Moderately, Quite a bit, and Extremely. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms." (NCT03248167)
Timeframe: Week 6

Interventionscore on a scale (Mean)
Cannabidiol (CBD 600 mg Daily)26.6364
Placebo26.8889

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Percent Carbohydrate Deficient Transferrin (CDT)

CDT test performed on blood sample (NCT03248167)
Timeframe: Baseline

Interventionpercentage of CDT (Mean)
Cannabidiol (CBD 600 mg Daily)1.1118
Placebo2.2833

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Percent Carbohydrate Deficient Transferrin (CDT)

CDT test performed on blood sample (NCT03248167)
Timeframe: Week 4

Interventionpercentage of CDT (Mean)
Cannabidiol (CBD 600 mg Daily)1.0909
Placebo1.4222

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Percent Carbohydrate Deficient Transferrin (CDT)

CDT test performed on blood sample (NCT03248167)
Timeframe: Week 6

Interventionpercentage of CDT (Mean)
Cannabidiol (CBD 600 mg Daily)1.14
Placebo1.6625

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Percentage of Days Abstinent

(NCT03248167)
Timeframe: Baseline

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)30
Placebo34

[back to top]

Percentage of Days Abstinent

(NCT03248167)
Timeframe: Week 1

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)55
Placebo57

[back to top]

Percentage of Days Abstinent

(NCT03248167)
Timeframe: Week 2

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)55
Placebo53

[back to top]

Percentage of Days Abstinent

(NCT03248167)
Timeframe: Week 3

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)66
Placebo56

[back to top]

Percentage of Days Abstinent

(NCT03248167)
Timeframe: Week 4

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)56
Placebo57

[back to top]

Percentage of Days Abstinent

(NCT03248167)
Timeframe: Week 5

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)52
Placebo51

[back to top]

Percentage of Days Abstinent

(NCT03248167)
Timeframe: Week 6

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)48
Placebo46

[back to top]

Percentage of Heavy Drinking Days

Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Baseline

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)49
Placebo58

[back to top]

Percentage of Heavy Drinking Days

Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 1

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)29
Placebo31

[back to top]

Percentage of Heavy Drinking Days

Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 2

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)25
Placebo31

[back to top]

Percentage of Heavy Drinking Days

Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 3

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)21
Placebo21

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Percentage of Heavy Drinking Days

Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 4

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)23
Placebo25

[back to top]

Percentage of Heavy Drinking Days

Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 5

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)26
Placebo32

[back to top]

Percentage of Heavy Drinking Days

Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 6

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)21
Placebo39

[back to top]

Percentage of Very Heavy Drinking Days

Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Baseline

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)17
Placebo27

[back to top]

Percentage of Very Heavy Drinking Days

Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week. (NCT03248167)
Timeframe: Week 1

Interventionpercentage of days (Mean)
Cannabidiol (CBD 600 mg Daily)4
Placebo4

[back to top]

Trough CBD Plasma Levels

"CBD trough plasma levels measured before dosing with CBD." (NCT03252756)
Timeframe: Baseline

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)0.7

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Percentage of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Baseline

Interventionpercentage of days (Mean)
Placebo58.6
Phytocannabinoid Cannabidiol (CBD)46.67

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 9

Interventionpercentage of days (Median)
Placebo24.29
Phytocannabinoid Cannabidiol (CBD)15.87

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 8

Interventionpercentage of days (Median)
Placebo18.57
Phytocannabinoid Cannabidiol (CBD)12.70

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 7

Interventionpercentage of days (Median)
Placebo18.57
Phytocannabinoid Cannabidiol (CBD)23.81

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 6

Interventionpercentage of days (Median)
Placebo18.57
Phytocannabinoid Cannabidiol (CBD)20.63

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 5

Interventionpercentage of days (Median)
Placebo15.71
Phytocannabinoid Cannabidiol (CBD)20.63

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 4

Interventionpercentage of days (Median)
Placebo41.43
Phytocannabinoid Cannabidiol (CBD)21.43

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 3

Interventionpercentage of days (Median)
Placebo32.86
Phytocannabinoid Cannabidiol (CBD)16.88

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 2

Interventionpercentage of days (Median)
Placebo37.14
Phytocannabinoid Cannabidiol (CBD)17.86

[back to top]

Penn Alcohol Craving Scale (PACS) Score

5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. (NCT03252756)
Timeframe: Week 9

Interventionscore on a scale (Median)
Placebo8.22
Phytocannabinoid Cannabidiol (CBD)11.33

[back to top]

Beck Anxiety Inventory (BAI) Score

21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. (NCT03252756)
Timeframe: Week 1

Interventionscore on a scale (Median)
Placebo5.6
Phytocannabinoid Cannabidiol (CBD)8

[back to top]

Beck Anxiety Inventory (BAI) Score

21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. (NCT03252756)
Timeframe: Baseline

Interventionscore on a scale (Median)
Placebo6.92
Phytocannabinoid Cannabidiol (CBD)8

[back to top]

Trough CBD Plasma Levels

"CBD trough plasma levels measured before dosing with CBD." (NCT03252756)
Timeframe: Week 9

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)22.71

[back to top]

Trough CBD Plasma Levels

"CBD trough plasma levels measured before dosing with CBD." (NCT03252756)
Timeframe: Week 8

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)100.03

[back to top]

Trough CBD Plasma Levels

"CBD trough plasma levels measured before dosing with CBD." (NCT03252756)
Timeframe: Week 5

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)74.54

[back to top]

Trough CBD Plasma Levels

"CBD trough plasma levels measured before dosing with CBD." (NCT03252756)
Timeframe: Week 4

InterventionCBD (ng/mL) (Median)
Placebo0.94
Phytocannabinoid Cannabidiol (CBD)31.21

[back to top]

Percent of Heavy Drinking Days

The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily. (NCT03252756)
Timeframe: Week 1

Interventionpercentage of days (Median)
Placebo35.71
Phytocannabinoid Cannabidiol (CBD)32.97

[back to top]

Penn Alcohol Craving Scale (PACS) Score

5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. (NCT03252756)
Timeframe: Baseline

Interventionscore on a scale (Median)
Placebo14.20
Phytocannabinoid Cannabidiol (CBD)17.77

[back to top]

Trough CBD Plasma Levels

"CBD trough plasma levels measured before dosing with CBD." (NCT03252756)
Timeframe: Week 1

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)22.79

[back to top]

Beck Anxiety Inventory (BAI) Score

21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. (NCT03252756)
Timeframe: Week 4

Interventionscore on a scale (Median)
Placebo3.33
Phytocannabinoid Cannabidiol (CBD)11.33

[back to top]

Beck Anxiety Inventory (BAI) Score

21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. (NCT03252756)
Timeframe: Week 5

Interventionscore on a scale (Median)
Placebo2.4
Phytocannabinoid Cannabidiol (CBD)6.57

[back to top]

Beck Anxiety Inventory (BAI) Score

21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. (NCT03252756)
Timeframe: Week 8

Interventionscore on a scale (Median)
Placebo4
Phytocannabinoid Cannabidiol (CBD)6.67

[back to top]

Beck Anxiety Inventory (BAI) Score

21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety. (NCT03252756)
Timeframe: Week 9

Interventionscore on a scale (Median)
Placebo1.89
Phytocannabinoid Cannabidiol (CBD)6.125

[back to top]

Beck Depression Inventory (BDI) Score

21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. (NCT03252756)
Timeframe: Week 1

Interventionscore on a scale (Median)
Placebo7.2
Phytocannabinoid Cannabidiol (CBD)7.83

[back to top]

Beck Depression Inventory (BDI) Score

21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. (NCT03252756)
Timeframe: Week 4

Interventionscore on a scale (Median)
Placebo5.2
Phytocannabinoid Cannabidiol (CBD)9

[back to top]

Beck Depression Inventory (BDI) Score

21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. (NCT03252756)
Timeframe: Week 5

Interventionscore on a scale (Median)
Placebo5.1
Phytocannabinoid Cannabidiol (CBD)7.67

[back to top]

Beck Depression Inventory (BDI) Score

21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. (NCT03252756)
Timeframe: Week 8

Interventionscore on a scale (Median)
Placebo4.67
Phytocannabinoid Cannabidiol (CBD)7.67

[back to top]

Beck Depression Inventory (BDI) Score

21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. (NCT03252756)
Timeframe: Week 9

Interventionscore on a scale (Median)
Placebo3.90
Phytocannabinoid Cannabidiol (CBD)6.5

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Baseline

InterventionDrinks per day (Median)
Placebo5.38
Phytocannabinoid Cannabidiol (CBD)4.61

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 1

Interventiondrinks per day (Median)
Placebo3.23
Phytocannabinoid Cannabidiol (CBD)2.91

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 2

Interventiondrinks per day (Median)
Placebo4.36
Phytocannabinoid Cannabidiol (CBD)2.37

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 3

Interventiondrinks per day (Median)
Placebo3.28
Phytocannabinoid Cannabidiol (CBD)1.83

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 4

Interventiondrinks per day (Median)
Placebo4.49
Phytocannabinoid Cannabidiol (CBD)2.13

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 5

Interventiondrinks per day (Median)
Placebo1.66
Phytocannabinoid Cannabidiol (CBD)2.39

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 6

Interventiondrinks per day (Median)
Placebo1.82
Phytocannabinoid Cannabidiol (CBD)2.38

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 7

Interventiondrinks per day (Median)
Placebo1.82
Phytocannabinoid Cannabidiol (CBD)2.57

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 8

Interventiondrinks per day (Median)
Placebo2.26
Phytocannabinoid Cannabidiol (CBD)1.99

[back to top]

Number of Drinks Per Day

The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days. (NCT03252756)
Timeframe: Week 9

Interventiondrinks per day (Median)
Placebo3.17
Phytocannabinoid Cannabidiol (CBD)2.40

[back to top]

Peak CBD Plasma Levels

"CBD peak plasma levels measured 45 minutes after dosing with CBD." (NCT03252756)
Timeframe: Baseline

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)52.04

[back to top]

Beck Depression Inventory (BDI) Score

21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression. (NCT03252756)
Timeframe: Baseline

Interventionscore on a scale (Median)
Placebo9.25
Phytocannabinoid Cannabidiol (CBD)9.92

[back to top]

Peak CBD Plasma Levels

"CBD peak plasma levels measured 45 minutes after dosing with CBD." (NCT03252756)
Timeframe: Day 1

InterventionCBD (ng/mL) (Median)
Placebo0.67
Phytocannabinoid Cannabidiol (CBD)104.45

[back to top]

Peak CBD Plasma Levels

"CBD peak plasma levels measured 45 minutes after dosing with CBD." (NCT03252756)
Timeframe: Week 1

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)83.67

[back to top]

Peak CBD Plasma Levels

"CBD peak plasma levels measured 45 minutes after dosing with CBD." (NCT03252756)
Timeframe: Week 4 + 1 Day

InterventionCBD (ng/mL) (Median)
Placebo66.17
Phytocannabinoid Cannabidiol (CBD)102.74

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Peak CBD Plasma Levels

"CBD peak plasma levels measured 45 minutes after dosing with CBD." (NCT03252756)
Timeframe: Week 4

InterventionCBD (ng/mL) (Median)
Placebo0.94
Phytocannabinoid Cannabidiol (CBD)211.83

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Peak CBD Plasma Levels

"CBD peak plasma levels measured 45 minutes after dosing with CBD." (NCT03252756)
Timeframe: Week 5

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)178.91

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Peak CBD Plasma Levels

"CBD peak plasma levels measured 45 minutes after dosing with CBD." (NCT03252756)
Timeframe: Week 8

InterventionCBD (ng/mL) (Median)
Placebo0
Phytocannabinoid Cannabidiol (CBD)275.012

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Penn Alcohol Craving Scale (PACS) Score

5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. (NCT03252756)
Timeframe: Week 1

Interventionscore on a scale (Median)
Placebo13.45
Phytocannabinoid Cannabidiol (CBD)14.09

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Penn Alcohol Craving Scale (PACS) Score

5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. (NCT03252756)
Timeframe: Week 4

Interventionscore on a scale (Median)
Placebo13.67
Phytocannabinoid Cannabidiol (CBD)10.33

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Penn Alcohol Craving Scale (PACS) Score

5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. (NCT03252756)
Timeframe: Week 5

Interventionscore on a scale (Median)
Placebo11.78
Phytocannabinoid Cannabidiol (CBD)11.78

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Penn Alcohol Craving Scale (PACS) Score

5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving. (NCT03252756)
Timeframe: Week 8

Interventionscore on a scale (Median)
Placebo10.22
Phytocannabinoid Cannabidiol (CBD)11.56

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Percent Change From Baseline in Time to Absence Seizure During Hyperventilation Testing on Video-EEG at Visit 5

A 4-hour video-EEG was performed for all participants at Baseline, during the Treatment Period, and at the End of the Study/Early Withdrawal Visit. Hyperventilation was conducted during the video-EEG to count the number of absence seizures. Percent change from baseline calculated as (100*(week 4-baseline)/baseline). (NCT03336242)
Timeframe: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)

Interventionpercent change (Mean)
Cohort 1162.24
Cohort 264.51

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Percent Change From Baseline in Absence Seizure Counts Assessed by Video-electroencephalogram (EEG) at Visit 5

A 4-hour video-EEG was performed for all participants at Baseline, during the Treatment Period, and at the End of the Study/Early Withdrawal Visit. Hyperventilation was conducted during the video-EEG to count the number of absence seizures. A negative change value indicates an improvement in seizure activity. A positive change value indicates a worsening in seizure activity. Percent change from baseline was calculated as (100*(week 4-baseline)/baseline). (NCT03336242)
Timeframe: Baseline (Visit 2, Day 1 of Titration Period) and Visit 5 (Week 4, Day 6 of Treatment Period)

Interventionpercent change (Mean)
Cohort 140.67
Cohort 235.12

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Number of Participants Seizure-Free at Visit 5

"Daily seizure activity was recorded in a diary. Each day, the participant or parent/caregiver responded to the question: How many absence seizures did the patient have today?." (NCT03336242)
Timeframe: Visit 5 (Week 4, Day 6 of Treatment Period)

InterventionParticipants (Count of Participants)
Cohort 11
Cohort 20

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Clinical Global Impression of Improvement (CGI-I) Score at Visit 5

The CGI-I questionnaire was completed by the parents/caregivers and the investigator and was used to assess participants' global status of their condition at Week 4 of the Treatment Period using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment. (NCT03336242)
Timeframe: Visit 5 (Week 4, Day 6 of Treatment Period)

Interventionunits on a scale (Mean)
Cohort 12.9
Cohort 23.1

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A treatment-emergent AE is an AE with onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported AEs module. (NCT03336242)
Timeframe: Day 1 (after dosing) up to Visit 7 (Week 4 of the Follow-Up Period)

,
Interventionparticipants (Number)
Number of participants with AEsNumber of participants with SAEs
Cohort 160
Cohort 270

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported AEs module. (NCT03355300)
Timeframe: Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks)

,
Interventionparticipants (Number)
Number of participants with AEsNumber of participants with SAEs
Canabidiol Oral Solution 20 to <30 mg/kg/Day50
Canabidiol Oral Solution 30 to <40 mg/kg/Day40

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Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set

The Clinical Global Impressions- Improvement global improvement item is a 7-point Likert scale designed to measure behavioral symptomatic change at a specific time compared to baseline. CGI-I is a standard global measure of potential change with treatment in placebo-controlled pharmacotherapy trials in developmental disabilities. The score ranges form 1-very much improved to 7-very much worse. The percentage of patients with any improvement (minimally, much, very much improved) was assessed. (NCT03614663)
Timeframe: Change in CGI-I at end of treatment (Week 12)

InterventionParticipants (Count of Participants)
ZYN002 - Cannabidiol Transdermal Gel46
Placebo Transdermal Gel37

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Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Ad Hoc Analysis

The Clinical Global Impressions- Improvement global improvement item is a 7-point Likert scale designed to measure behavioral symptomatic change at a specific time compared to baseline. CGI-I is a standard global measure of potential change with treatment in placebo-controlled pharmacotherapy trials in developmental disabilities. The score ranges form 1-very much improved to 7-very much worse. The percentage of patients with any improvement (minimally, much, very much improved) was assessed. (NCT03614663)
Timeframe: Change in CGI-I at end of treatment (Week 12)

InterventionParticipants (Count of Participants)
ZYN002 - Cannabidiol Transdermal Gel43
Placebo Transdermal Gel25

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Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Full Analysis Set

The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 and 39, and a higher mean indicates a worse outcome. (NCT03614663)
Timeframe: Change from baseline to end of treatment (Week 12)

InterventionChange in score (Least Squares Mean)
ZYN002 - Cannabidiol Transdermal Gel-3.50
Placebo Transdermal Gel-3.14

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Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Ad Hoc Analysis

The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 to 39 , and the higher score means a worse outcome. (NCT03614663)
Timeframe: Change from baseline in ABC-C to end of treatment (Week 12)

InterventionChange in score (Least Squares Mean)
ZYN002 - Cannabidiol Transdermal Gel-3.91
Placebo Transdermal Gel-2.74

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Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Full Analysis Set

The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 to 12, and a higher value indicates a worse outcome. (NCT03614663)
Timeframe: Change from Baseline to end of treatment (Week 12)

Interventionchange in score (Least Squares Mean)
ZYN002 - Cannabidiol Transdermal Gel-2.68
Placebo-2.29

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Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Ad Hoc Analysis

The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 and 12, and the higher score means a worse outcome. (NCT03614663)
Timeframe: Change from baseline to end of treatment (Week 12)

InterventionChange in score (Least Squares Mean)
ZYN002 - Cannabidiol Transdermal Gel-2.99
Placebo-1.99

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Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Full Analysis Set

The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is between 0 and 54, and the higher score means a worse outcome. (NCT03614663)
Timeframe: Change from baseline to end of treatment (Week 12)

InterventionChange in score (Least Squares Mean)
ZYN002 - Cannabidiol Transdermal Gel-5.88
Placebo Transdermal Gel-4.14

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Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Ad Hoc Analysis

The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is between 0 and 54, and the higher score means a worse outcome. (NCT03614663)
Timeframe: Change from baseline in ABC-C to end of treatment (Week 12)

InterventionChange in score (Least Squares Mean)
ZYN002 - Cannabidiol Transdermal Gel-6.43
Placebo Transdermal Gel-4.13

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Global Impression of Change

The Global impression of change will be calculated based on both physician and patient report. The scale ranges from a score of 1 (very much improved) to 7 (very much worse) with a score of 4 indicating 'no change'. (NCT03805750)
Timeframe: Day 22

,
Interventionscore on a scale (Mean)
Clinical Global Impression of ChangePatient Global Impression of Change
CBD/THC33
Placebo44

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Number of Participants Reporting Adverse Events Based on Common Terminology Criteria

Side effects survey (NCT03805750)
Timeframe: Days 1, 3, 6, 22

,
InterventionParticipants (Count of Participants)
Ringing in earsNumbness/tinglingDyspnea on exertionWatery eyesRunny noseDecreased concentrationSleepinessInsomniaIncreased sleepinessDizzinessMemory problemsImbalanceMild headacheGroggyTiredThumb painAnxietyHeadacheLightheadedFelt highDecreased libidoDiarrheaDry mouthEuphoriaFatigueFeels relaxedIncreased thirstFelt buzzedQuivering voiceVisual slowing
CBD/THC744337402433000022211111111111
Placebo644320121000111100000000000000

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Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

This is a scale looking at risk assessment of suicidality. The presence of any positive responses will lead to further evaluation. (NCT03805750)
Timeframe: Day 22

InterventionParticipants (Count of Participants)
CBD/THC0
Placebo0

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Accelerometry-based Assessment of Tremor Severity

The spectral power density measure of accelerometry data to measure will serve as a measure of tremor severity, comparing tremor amplitude from this digital biomarker at the time of the primary outcome to the same measure at baseline. (NCT03805750)
Timeframe: Baseline and Day 22

InterventionProportion of baseline spectral power (Mean)
CBD/THC0.012
Placebo0.007

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Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)

The performance sub scale of the TETRAS will be used to measure tremor severity. The scale ranges from 0 to 60 points (0 being no tremor). (NCT03805750)
Timeframe: Baseline and Day 22

Interventionscore on a scale (Mean)
CBD/THC-8.07
Placebo-10.3

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Digital Spirography

The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors. (NCT03805750)
Timeframe: Day 22 (100 minutes post-dose)

Interventionmillimeters of tremor amplitude (Mean)
CBD/THC1.04
Placebo1.00

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Change From Baseline in the Mean RSBQ Total Score at Week 24 for the 5 mg/kg/Day GWP42003-P Dose Level Compared With Placebo

"RSBQ is a caregiver-completed questionnaire that measures the frequency of current disease characteristics (45 items) in individuals with Rett Syndrome. Each item is rated on a 3-point scale (0-2); 0 indicating an item that is not true as far as you know, 1 indicating an item is somewhat or sometimes true, and 2 indicating an item that is very true or often true. Item 31 (Uses eye gaze to convey feelings, needs and wishes) is reverse scored (0 indicating very true or often true, 1 indicating somewhat or sometimes true, and 2 indicating not true as far as you know). The total summed score ranges from 0 to 90, with higher scores represent greater severity." (NCT03848832)
Timeframe: Baseline; Week 24

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 24
5 mg/kg/Day GWP42003-P39.80.4
Placebo50.0-6.1

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Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24

MBA-9 is derived from the full MBA scale (37 Rett syndrome symptoms) by selecting the items deemed amenable to change and which reflected areas of meaningful clinical change. the MBA-9 includes 9 items (1-Regression of motor skills; 2-Poor eye/social contact; 3-Lack of sustained interest; 4-Does not reach for objects or people; 5-Chewing difficulties; 6-Speech disturbance; 7-Hand clumsiness; 8-Dystonia and 9-Hypertonia/rigidity); for each item, the severity of current symptoms is rated by the investigator on a 5-point numerical scale ranging from 0 to 4 with higher scores representing greater severity (0 = normal or never; 1 = mild or rare; 2 = moderate or occasional; 3 = marked or frequent; 4 = very severe or constant). Total MBA-9 score was calculated by summing the scores of 9 different subscale items. The total summed score ranges from 0 to 36, with higher scores representing greater severity. CFB = Change from Baseline. (NCT03848832)
Timeframe: Baseline; Week 24

,,
Interventionunits on a scale (Mean)
Baseline Regression of Motor SkillsCFB Regression of Motor SkillsBaseline Poor Eye/Social ContactCFB Poor Eye/Social ContactBaseline Lack of Sustained InterestCFB Lack of Sustained InterestBaseline Does Not Reach for Objects or PeopleCFB Does Not Reach for Objects or PeopleBaseline Chewing DifficultiesCFB Chewing DifficultiesBaseline Speech DisturbanceCFB Speech DisturbanceBaseline Hand ClumsinessCFB Hand ClumsinessBaseline DysoniaCFB DysoniaBaseline Hypertonia/RigidityCFB Hypertonia/RigidityBaseline MBA-9 Total ScoreCFB MBA-9 Total Score
15 mg/kg/Day GWP42003-P2.6-0.31.6-0.12.1-0.31.9-0.41.30.02.80.02.8-0.41.2-0.11.1-0.117.3-1.9
5 mg/kg/Day GWP42003-P2.20.31.70.01.80.02.0-0.41.3-0.23.00.02.8-0.61.00.41.40.417.20.0
Placebo2.60.01.5-0.91.5-0.12.30.11.10.42.70.33.10.01.00.11.00.016.80.0

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Change From Baseline in the Mean Rett Syndrome Behaviour Questionnaire (RSBQ) Total Score at Week 24 for the 15 mg/kg/Day GWP42003-P Dose Level Compared With Placebo

"RSBQ is a caregiver-completed questionnaire that measures the frequency of current disease characteristics (45 items) in individuals with Rett Syndrome. Each item is rated on a 3-point scale (0-2); 0 indicating an item that is not true as far as you know, 1 indicating an item is somewhat or sometimes true, and 2 indicating an item that is very true or often true. Item 31 (Uses eye gaze to convey feelings, needs and wishes) is reverse scored (0 indicating very true or often true, 1 indicating somewhat or sometimes true, and 2 indicating not true as far as you know). The total summed score ranges from 0 to 90, with higher scores representing greater severity." (NCT03848832)
Timeframe: Baseline; Week 24

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 24
15 mg/kg/Day GWP42003-P45.9-12.1
Placebo50.0-6.1

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Change From Baseline in Mean RSBQ Subscale Scores at Week 24

"RSBQ is a caregiver-completed questionnaire that measures the frequency of current disease characteristics in individuals with Rett Syndrome. The 45-item RSBQ is comprised of 8 subscales: 1) general mood (score range 0-16), 2) breathing problems (range 0-10), 3) hand behaviors (range 0-12), 4) face movements (range 0-8), 5) body rocking (BR)/expressionless face (range 0-12), 6) night-time behaviors (range 0-6), 7) anxiety/fear (range 0-8), 8) walking/standing (range 0-4). Each item is rated on a 3-point scale (0-2); 0 indicating an item that is not true as far as you know, 1 indicating an item is somewhat or sometimes true, and 2 indicating an item that is very true or often true. Item 31 (Uses eye gaze to convey feelings, needs and wishes) is reverse scored (0 indicating very true or often true, 1 indicating somewhat or sometimes true, and 2 indicating not true as far as you know). Higher scores representing greater severity. CFB = Change from Baseline." (NCT03848832)
Timeframe: Baseline; Week 24

,,
Interventionunits on a scale (Mean)
Baseline General Mood ScoreCFB General Mood ScoreBaseline Breathing Problems ScoreCFB Breathing Problems ScoreBaseline Hand Behaviors ScoreCFB Hand Behaviors ScoreBaseline Face Movements ScoreCFB Face Movements ScoreBaseline Body Rocking/Expressionless Face ScoreCFB Body Rocking/Expressionless Face ScoreBaseline Night-time Behaviors ScoreCFB Night-time Behaviors ScoreBaseline Anxiety/Fear ScoreCFB Anxiety/Fear ScoreBaseline Walking/Standing ScoreCFB Walking/Standing Score
15 mg/kg/Day GWP42003-P8.2-4.95.0-1.07.6-0.94.6-1.45.1-0.60.8-0.14.6-1.32.10.0
5 mg/kg/Day GWP42003-P6.0-0.64.70.27.80.72.30.04.50.60.80.24.0-0.22.70.9
Placebo8.9-2.65.0-0.39.10.14.3-0.15.4-0.11.8-0.35.1-1.72.90.1

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Change From Baseline in Mean Clinician Global Impressions - Severity (CGI-S) Score at Week 24

CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment relative to the clinician's experience with participants who had the same diagnosis. This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. (NCT03848832)
Timeframe: Baseline; Week 24

,,
Interventionunits on a scale (Mean)
BaselineChange from Baseline at Week 24
15 mg/kg/Day GWP42003-P4.2-0.1
5 mg/kg/Day GWP42003-P4.3-0.1
Placebo4.40.0

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Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24

"CSHQ is a caregiver-completed sleep screening instrument designed for school-aged children; which includes 33 items within 8 subscales: 1) bedtime resistance (score range 6-18), 2) sleep onset delay (range 1-3), 3) sleep duration (range 3-9), 4) sleep anxiety (range 4-12), 5) night wakings (range 3-9), 6) parasomnias (range 7-21), 7) sleep-disordered breathing (range 3-9), 8) daytime sleepiness (range 8-24). Item scores range from 1 to 3, where 3=usually (≥5 times/week), 2=sometimes (2-4 times/week), and 1=rarely (≤1 time/week); for items 31 and 32; 3=fall asleep, 2=very sleepy, 1=not sleepy. In general, a score of 3 indicates greater severity, however, 6 items (1-Goes to bed at same time; 2-Falls asleep in 20 minutes; 3-Falls asleep in own bed; 10-Sleeps the right amount; 11-Sleeps same amount each day; 26-Wakes by himself) are reverse scored. Total summed score ranges from 33 to 99, with higher scores representing more disturbed sleep behavior. CFB = Change from Baseline." (NCT03848832)
Timeframe: Baseline; Week 24

,,
Interventionunits on a scale (Mean)
Baseline Total ScoreCFB Total scoreBaseline Bedtime resistanceCFB Bedtime resistanceBaseline Sleep onset delayCFB Sleep onset delayBaseline Sleep durationCFB Sleep durationBaseline Sleep anxietyCFB Sleep anxietyBaseline Night wakingsCFB Night wakingsBaseline ParasomniasCFB ParasomniasBaseline Sleep disordered breathingCFB Sleep disordered breathingBaseline Daytime sleepinessCFB Daytime sleepiness
15 mg/kg/Day GWP42003-P46.7-5.07.3-0.41.4-0.13.4-0.34.6-0.14.4-0.610.4-1.14.0-0.913.2-1.4
5 mg/kg/Day GWP42003-P49.8-1.69.20.01.50.14.70.45.6-0.15.3-0.411.0-0.64.2-0.411.6-0.7
Placebo49.4-3.77.0-0.11.8-0.64.5-0.44.90.04.60.111.7-1.43.7-0.113.7-1.3

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Mean Clinical Global Impressions - Improvement (CGI-I) Score at Week 24

CGI-I is a 7-point scale that requires the clinician to assess how much a participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention. This is rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. (NCT03848832)
Timeframe: Baseline; Week 24

Interventionunits on a scale (Mean)
5 mg/kg/Day GWP42003-P3.2
15 mg/kg/Day GWP42003-P2.9
Placebo3.1

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Changes in Brain Positron Emission Tomography Signal

The investigators will test for the presence of a significant treatment effect in the brain [11C]PBR28 signal. (NCT03891264)
Timeframe: 4 weeks

InterventionStandardized Uptake Values (SUVs) (Mean)
CBD Arm0.00197

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Changes in Pain Outcomes as Measured by Self Report on a 0-10 Numerical Pain Rating Scale (Worst Pain in the Past 24 Hours).

The investigators will test for the presence of a significant treatment effect in pain outcomes on a self reported numerical (0-10) pain rating scale. Higher number indicates worse pain. (NCT03891264)
Timeframe: 4 weeks

Interventionscore on a scale (Mean)
CBD Arm4.5

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Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration

"Change in cue-induced cravings and anxiety measured before and after 3 days of cannabidiol administration. Subjects will use the Cue-Induced Opioid Craving and Anxiety Scales to note their responses using a visual analog scale of 0 to 10, 0 being not at all and 10 being extremely. Higher scores thus mean a worse outcome (i.e. more intense cravings/anxiety)." (NCT04192370)
Timeframe: pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study)

Interventionscore on a scale (Mean)
CannabidiolPre-CBD
Cannabidiol3.20.4

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Safety as Assessed by Number of Adverse Events

Number of Adverse Events reported across sessions with and without study drug. Adverse events were collected for the entire 57 hour session. (NCT04238754)
Timeframe: through completion of the two study sessions, an average of 17 days

InterventionAdverse Events (Number)
Placebo Adverse EventsEpidiolex Adverse Events
All Participants45

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Initial Efficacy of Study Drug as Assessed by Area Under the Curve for the Subjective Opiate Withdrawal Scale (SOWS) Scores

Withdrawal symptom suppression during active and placebo conditions. Area Under the Curve (AUC) analyses will be calculated to characterize withdrawal on the Subjective Opiate Withdrawal Scale (SOWS) scores across time. SOWS AUC will be compared between the two conditions. AUC will range from 0 to 3072 where 0 represents no withdrawal during study drug administration and 3072 represents the most severe withdrawal during study drug administration. (NCT04238754)
Timeframe: After first administration of study drug and up to 48 hours

Interventionscores on SOWS scale X hour (Mean)
Epidiolex1334.7
Placebo1591.5

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Change in Withdrawal Scores From Baseline AfterReceiving Placebo

Change in withdrawal scores during laboratory evaluation of spontaneous withdrawal. Withdrawal is measured with the Subjective Opiate Withdrawal Scale (SOWS). That has a range of 0-64 where a mild score is represented by a score of 1-10, a moderate score is represented by a score of 11-20 and a severe score is considered anything greater than 21. (NCT04238754)
Timeframe: Baseline, during residential session up to 57 hours

Interventionscore on a scale (Mean)
All Participants15.8

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Acceptability Assessed by Rating of Medication Acceptance on a 5-point Acceptance Rating Scale

Participant rating of medication acceptance on a 5-point acceptance rating scale. The acceptance rating scale will range from 0-4 where 0 represents no acceptance of the medication and 4 represents complete acceptance of the medication. (NCT04238754)
Timeframe: at the end of the 57-hour residential session, prior to discharge

Interventionscore on a scale (Mean)
Epidiolex4
Placebo4

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Acceptability Assessed by Number of Participants Who Would Recommend the Medication to a Family Member or Friend

Number of participants who would recommend the medication to a family member or friend trying to taper down from opioid medications. (NCT04238754)
Timeframe: at the end of the 57-hour residential session, prior to discharge

InterventionParticipants (Count of Participants)
Epidiolex3
Placebo2

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Number of Participants Whose Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) Levels >3x Upper Limit of Normal

Number of participants whose AST/ALT levels >3x upper limit of normal (ULN) at the end of a study session when they receive Epidiolex and Placebo. This will be used in the assessment of safety. (NCT04238754)
Timeframe: End of residential stay, prior to discharge

InterventionParticipants (Count of Participants)
Epidiolex0
Placebo0

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Acceptability Assessed by Visual Analog Ratings

Visual analog ratings of the degree to which the medication suppressed opioid withdrawal symptoms. The visual analog ratings will be scored on a scale from 0-100 where 0 represents no suppression of withdrawal and 100 represents complete suppression of withdrawal. (NCT04238754)
Timeframe: at the end of the 57-hour residential session, prior to discharge

Interventionunits on a scale (Mean)
Epidiolex24.333
Placebo17.5

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Number of Participants With At Least One Post Open Label Extension Baseline Flagged ECG Result

Electrocardiogram assessments were performed for QTcB and QTcF >450 msec, >480 msec, and >500 msec. QTcB = corrected QT interval with Bazette correction. QTcF = QTc corrected by Fridericia. (NCT04252586)
Timeframe: Visit 4 (Day 29) up to Visit 15 (Day 739) in the OLE

InterventionParticipants (Count of Participants)
QTcB Interval, Aggregate > 450 msec, Day 29QTcB Interval, Aggregate > 450 msec, Day 57QTcB Interval, Aggregate > 450 msec, Day 85QTcB Interval, Aggregate > 450 msec, Day 141QTcB Interval, Aggregate > 450 msec, Day 197QTcB Interval, Aggregate > 450 msec, Day 365QTcB Interval, Aggregate > 450 msec, End of Treatment (up to Day 729)QTcB Interval, Aggregate > 450 msec, Day 739QTcB Interval, Aggregate > 480 msec, Day 29QTcB Interval, Aggregate > 480 msec, Day 57QTcB Interval, Aggregate > 480 msec, Day 85QTcB Interval, Aggregate > 480 msec, Day 141QTcB Interval, Aggregate > 480 msec, Day 197QTcB Interval, Aggregate > 480 msec, Day 365QTcB Interval, Aggregate > 480 msec, End of Treatment (up to Day 729)QTcB Interval, Aggregate > 480 msec, Day 739QTcB Interval, Aggregate > 500 msec, Day 29QTcB Interval, Aggregate > 500 msec, Day 57QTcB Interval, Aggregate > 500 msec, Day 85QTcB Interval, Aggregate > 500 msec, Day 141QTcB Interval, Aggregate > 500 msec, Day 197QTcB Interval, Aggregate > 500 msec, Day 365QTcB Interval, Aggregate > 500 msec, End of Treatment (up to Day 729)QTcB Interval, Aggregate > 500 msec, Day 739QTcF Interval, Aggregate > 450 msec, Day 29QTcF Interval, Aggregate > 450 msec, Day 57QTcF Interval, Aggregate > 450 msec, Day 85QTcF Interval, Aggregate > 450 msec, Day 141QTcF Interval, Aggregate > 450 msec, Day 197QTcF Interval, Aggregate > 450 msec, Day 365QTcF Interval, Aggregate > 450 msec, End of Treatment (up to Day 729)QTcF Interval, Aggregate > 450 msec, Day 739QTcF Interval, Aggregate > 480 msec, Day 29QTcF Interval, Aggregate > 480 msec, Day 57QTcF Interval, Aggregate > 480 msec, Day 85QTcF Interval, Aggregate > 480 msec, Day 141QTcF Interval, Aggregate > 480 msec, Day 197QTcF Interval, Aggregate > 480 msec, Day 365QTcF Interval, Aggregate > 480 msec, End of Treatment (up to Day 729)QTcF Interval, Aggregate > 480 msec, Day 739QTcF Interval, Aggregate > 500 msec, Day 29QTcF Interval, Aggregate > 500 msec, Day 57QTcF Interval, Aggregate > 500 msec, Day 85QTcF Interval, Aggregate > 500 msec, Day 141QTcF Interval, Aggregate > 500 msec, Day 197QTcF Interval, Aggregate > 500 msec, Day 365QTcF Interval, Aggregate > 500 msec, End of Treatment (up to Day 729)QTcF Interval, Aggregate > 500 msec, Day 739
GWP42003-P404000400010001000000000001000000000000000000000

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Number of Participants With Treatment-emergent Clinical Laboratory Parameters From the Baseline at Any Time Post-dose

Treatment-emergent clinical parameters were defined as the following: Treatment-emergent alanine transferase (ALT) > 3×upper limit of normal (ULN), > 5×ULN and > 8×ULN; Treatment-emergent aspartate aminotransferase (AST) > 3×ULN, > 5×ULN and > 8×ULN; Treatment-emergent ALT or AST > 3×ULN, > 5×ULN and > 8×ULN; Treatment-emergent ALT or AST > 3×ULN and either bilirubin > 2×ULN or international normalized ratio (INR) > 1.5. (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

InterventionParticipants (Count of Participants)
Treatment-emergent ALT >3xULNTreatment-emergent ALT >5xULNTreatment-emergent ALT >8xULNTreatment-emergent AST >3xULNTreatment-emergent AST >5xULNTreatment-emergent AST >8xULNTreatment-emergent ALT or AST >3xULNTreatment-emergent ALT or AST >5xULNTreatment-emergent ALT or AST >8xULNTreatment-emergent ALT or AST > 3×ULN and either bilirubin > 2×ULN or INR > 1.5
GWP42003-P1000001000

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Mean Change From Baseline in 9-item Motor Behavioral Assessment (MBA-9) Total Score at End of Treatment

MBA-9 is derived from the full MBA scale (37 Rett syndrome symptoms) by selecting the items deemed amenable to change and which reflected areas of meaningful clinical change. The MBA-9 includes 9 items (Regression of motor skills; Poor eye/social contact; Lack of sustained interest; Does not reach for objects or people; Chewing difficulties; Speech disturbance; Hand clumsiness; Dystonia; and Hypertonia/rigidity). For each item, the severity of current symptoms is rated by the investigator on a 5-point numerical scale ranging from 0 to 4 with higher scores representing greater severity (0 = normal or never; 1 = mild or rare; 2 = moderate or occasional; 3 = marked or frequent; 4 = very severe or constant). Total MBA-9 score was calculated by summing the scores of 9 different subscale items. The total summed score ranges from 0 to 36, with higher scores representing greater severity. A negative mean change from baseline indicates improvement in behavior. (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

Interventionunits on a scale (Mean)
GWP42003-P0.7

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Mean Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Levels at End of Treatment

Blood samples were collected to assess changes in serum IGF-1 levels. A negative mean change from baseline indicates a reduction in IGF-1 levels. (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

Interventionunits on a scale (Mean)
GWP42003-P-41.1

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Number of Participants With Changes in Tanner Staging at the Baseline and at End of Treatment

"Pubic hair growth and breast development of all adolescents were assessed by the investigator or caregiver using Tanner Staging categorization from 1 to 5.~Stage 1- No glandular tissue; areola follows skin contours of chest; No pubic hair Stage 2- Breast bud forms; areola begins to widen; a small amount of long, downy hair with slight pigmentation on labia majora Stage 3- Breast begins to become more elevated and extends beyond borders of the areola, which continues to widen but remains in contour with surrounding breast; Hair becomes more coarse and curly and begins to extend laterally Stage 4- Increased breast size and elevation; areola and papilla form a secondary mound projecting from the contour of the surrounding breast; Adult-like hair quality, extending across pubis but sparing medial thighs Stage 5- Breast reaches final adult size; areola returns to the contour of the surrounding breast, with a projecting central papilla; Hair extends to medial surface of the thigh." (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

InterventionParticipants (Count of Participants)
Baseline, Tanner Stage 1Baseline, Tanner Stage 2Baseline, Tanner Stage 3Baseline, Tanner Stage 4Baseline, Tanner Stage 5Baseline, Tanner Stage MissingEnd of Treatment (up to Day 729), Tanner Stage 1End of Treatment (up to Day 729), Tanner Stage 2End of Treatment (up to Day 729), Tanner Stage 3End of Treatment (up to Day 729), Tanner Stage 4End of Treatment (up to Day 729), Tanner Stage 5End of Treatment (up to Day 729), Tanner Stage Missing
GWP42003-P631245421335

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Number of Participants With Clinically Significant Changes in the Vital Sign Values of Pulse Rate From the Baseline at Any Time Post-dose

Potentially clinically significant vital sign values of pulse rate were defined as pulse rate change: < -10 or > 10 beats per minute. Vital sign measurements were taken in a sitting position at rest for 5 minutes. (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 15 (Day 739) in the OLE

InterventionParticipants (Count of Participants)
Pulse Rate Change <-10beats/min, BaselinePulse Rate Change <-10beats/min, Day 29Pulse Rate Change <-10beats/min, Day 57Pulse Rate Change <-10beats/min, Day 85Pulse Rate Change <-10beats/min, Day 141Pulse Rate Change <-10beats/min, Day 197Pulse Rate Change <-10beats/min, Day 281Pulse Rate Change <-10beats/min, Day 365Pulse Rate Change <-10beats/min, End of Treatment (up to Day 729)Pulse Rate Change <-10beats/min, Day 739Pulse Rate Change >10beats/min, BaselinePulse Rate Change >10beats/min, Day 29Pulse Rate Change >10beats/min, Day 57Pulse Rate Change >10beats/min, Day 85Pulse Rate Change >10beats/min, Day 141Pulse Rate Change >10beats/min, Day 197Pulse Rate Change >10beats/min, Day 281Pulse Rate Change >10beats/min, Day 365Pulse Rate Change >10beats/min, End of Treatment (up to Day 729)Pulse Rate Change >10beats/min, Day 739
GWP42003-P98772511605233310042

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Number of Participants With Clinically Significant Percent Change in Body Weight From the Baseline at Any Time Post-dose

Clinically significant body weight changes were defined as the percent change in body weight (≤7% change or ≥7% change). (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

InterventionParticipants (Count of Participants)
Weight Percent Change ≤7%, BaselineWeight Percent Change ≤7%, End of Treatment (up to Day 729)Weight Percent Change ≥7%, BaselineWeight Percent Change ≥7%, End of Treatment (up to Day 729)
GWP42003-P11810

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Number of Participants With Potentially Clinically Significant Changes in Vital Sign Values of Blood Pressure From the Baseline at Any Time Post-dose

Potentially clinically significant vital sign values of blood pressure (BP) were defined as sitting systolic BP (mmHg) change: < -20 or > 20 mmHg and sitting diastolic BP change: < -10 or > 10 mmHg. Vital sign measurements were taken in a sitting position at rest for 5 minutes. Blood pressure readings were recorded using the same arm throughout the trial, when possible. (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 15 (Day 739) in the OLE

InterventionParticipants (Count of Participants)
Systolic BP Change <-20 mmHg, BaselineSystolic BP Change <-20 mmHg, Day 29Systolic BP Change <-20 mmHg, Day 57Systolic BP Change <-20 mmHg, Day 85Systolic BP Change <-20 mmHg, Day 141Systolic BP Change <-20 mmHg, Day 197Systolic BP Change <-20 mmHg, Day 281Systolic BP Change <-20 mmHg, Day 365Systolic BP Change <-20 mmHg, End of Treatment (up to Day 729)Systolic BP Change <-20 mmHg, Day 739Systolic BP Change >20 mmHg, BaselineSystolic BP Change >20 mmHg, Day 29Systolic BP Change >20 mmHg, Day 57Systolic BP Change >20 mmHg, Day 85Systolic BP Change >20 mmHg, Day 141Systolic BP Change >20 mmHg, Day 197Systolic BP Change >20 mmHg, Day 281Systolic BP Change >20 mmHg, Day 365Systolic BP Change >20 mmHg, End of Treatment (up to Day 729)Systolic BP Change >20 mmHg, Day 739Diastolic BP Change <-10 mmHg, BaselineDiastolic BP Change <-10 mmHg, Day 29Diastolic BP Change <-10 mmHg, Day 57Diastolic BP Change <-10 mmHg, Day 85Diastolic BP Change <-10 mmHg, Day 141Diastolic BP Change <-10 mmHg, Day 197Diastolic BP Change <-10 mmHg, Day 281Diastolic BP Change <-10 mmHg, Day 365Diastolic BP Change <-10 mmHg, End of Treatment (up to Day 729)Diastolic BP Change <-10 mmHg, Day 739Diastolic BP Change >10 mmHg, BaselineDiastolic BP Change >10 mmHg, Day 29Diastolic BP Change >10 mmHg, Day 57Diastolic BP Change >10 mmHg, Day 85Diastolic BP Change >10 mmHg, Day 141Diastolic BP Change >10 mmHg, Day 197Diastolic BP Change >10 mmHg, Day 281Diastolic BP Change >10 mmHg, Day 365Diastolic BP Change >10 mmHg, End of Treatment (up to Day 729)Diastolic BP Change >10 mmHg, Day 739
GWP42003-P4211220011113200002074423300304944310050

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Number of Participants With Suicidal Ideation or Behavior at the Baseline and at Any Time Post-dose

Suicidal ideation and behavior was assessed by the investigator via a clinical interview with the caregiver. The questionnaire included following questions: Has the child expressed any wish to be dead?, Has the child made any suicide attempts?, Has the child shown any non-suicidal self-injurious behavior? The responses were recorded as Yes/No. (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

InterventionParticipants (Count of Participants)
Has the child expressed any wish to be dead? Yes, BaselineHas the child expressed any wish to be dead? No, BaselineHas the child expressed any wish to be dead? Unknown/Missing, BaselineHas the child expressed any wish to be dead? Yes, End of Treatment (up to Day 729)Has the child expressed any wish to be dead? No, End of Treatment (up to Day 729)Has the child made any suicide attempts? Yes, BaselineHas the child made any suicide attempts? No, BaselineHas the child made any suicide attempts? Unknown/Missing, BaselineHas the child made any suicide attempts? Yes, End of Treatment (up to Day 729)Has the child made any suicide attempts? No, End of Treatment (up to Day 729)Has the child shown any non-suicidal self-injurious behavior? Yes, BaselineHas the child shown any non-suicidal self-injurious behavior? Yes, usual behavior, BaselineHas the child shown any non-suicidal self-injurious behavior? Yes, worsening behavior, BaselineHas the child shown any non-suicidal self-injurious behavior? No, BaselineHas the child shown any non-suicidal self-injurious behavior? Unknown/Missing, BaselineHas the child shown any non-suicidal self-injurious behavior? Yes, End of Treatment (up to Day 729)Has child shown any non-suicidal self-injurious behavior? Yes, usual behavior, EOT (up to Day 729)Has child shown any non-suicidal self-injurious behavior? Yes, worse behavior, EOT (up to Day 729)Has child shown any non-suicidal self-injurious behavior? No, End of Treatment (up to Day 729)
GWP42003-P0165018016501803013504014

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Mean Clinical Global Impressions-Improvement (CGI-I) Continuous Score at End of Treatment

CGI-I is a 7-point scale that requires the clinician to assess whether a patient's condition has improved or worsened relative to a baseline state at the beginning of the intervention. This was rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. The mean continuous CGI-I score (averaged from each treatment enrolled under protocol and under annex) at Visit 14 (Day 729) is being reported. Higher mean scores indicate worse condition. (NCT04252586)
Timeframe: Visit 14 (Day 729) in the OLE

Interventionscore on a scale (Mean)
GWP42003-P3.3

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Mean Change From Baseline in Rett Syndrome Behaviour Questionnaire (RSBQ) Overall Score at End of Treatment

"RSBQ is a caregiver-completed questionnaire that assesses the overall condition (45 items) in individuals with Rett Syndrome. Each item is rated on a 3-point scale (0-2); 0 indicating an item that is not true as far as you know, 1 indicating an item is somewhat or sometimes true, and 2 indicating an item that is very true or often true. Item 31 (Uses eye gaze to convey feelings, needs and wishes) is reverse-scored (0 indicating very true or often true, 1 indicating somewhat or sometimes true, and 2 indicating not true as far as you know). The total summed score ranges from 0 to 90, with higher scores representing greater severity. A negative mean change from baseline indicates an improvement in overall condition." (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

Interventionunits on a scale (Mean)
GWP42003-P-7.4

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Number of Participants With Any Changes In Menstruation Cycle at Any Time Post-dose

Participants were evaluated for any changes to typical menstrual cycles, duration of menstrual cycles, and typical strength of the menstrual cycles during the study. (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

InterventionParticipants (Count of Participants)
Any change to typical cycle, Yes; Day 1Any change to typical cycle, No; Day 1Any change to typical cycle; Day 1 Unknown/MissingTypical duration of menstruation cycle, <3 days; Day 1Typical duration of menstruation cycle, 3-7 days; Day 1Typical duration of menstruation cycle, >7 days; Day 1Typical duration of menstruation cycle; Day 1 Unknown/MissingTypical strength of menstruation cycle, Light; Day 1Typical strength of menstruation cycle, Moderate; Day 1Typical strength of menstruation cycle, Heavy; Day 1Typical strength of menstruation cycle, Other; Day 1Typical strength of menstruation cycle; Day 1 Unknown/MissingAny change to typical cycle, Yes; End of Treatment (up to Day 729)Any change to typical cycle, No; End of Treatment (up to Day 729)Any change to typical cycle; End of Treatment (up to Day 729) Unknown/MissingTypical duration of menstruation cycle, <3 days; End of Treatment (up to Day 729)Typical duration of menstruation cycle, 3-7 days; End of Treatment (up to Day 729)Typical duration of menstruation cycle, >7 days; End of Treatment (up to Day 729)Typical duration of menstruation cycle; End of Treatment (up to Day 729) Unknown/MissingTypical strength of menstruation cycle, Light; End of Treatment (up to Day 729)Typical strength of menstruation cycle, Heavy; End of Treatment (up to Day 729)Typical strength of menstruation cycle, Moderate; End of Treatment (up to Day 729)Typical strength of menstruation cycle, Other; End of Treatment (up to Day 729)Typical strength of menstruation cycle; End of Treatment (up to Day 729) Unknown/Missing
GWP42003-P111901020100020331203015120015

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Mean Change From Baseline in Children's Sleep Habits Questionnaire (CSHQ) Total Score at End of Treatment

"CSHQ is a caregiver-completed sleep screening instrument designed for school-aged children; which includes 33 items within 8 subscales:bedtime resistance (score range 6-18), sleep onset delay (range 1-3), sleep duration (range 3-9), sleep anxiety (range 4-12), night wakings (range 3-9), parasomnias (range 7-21), sleep-disordered breathing (range 3-9), daytime sleepiness (range 8-24). The 33 items range from 1 to 3, where 3=usually (≥5 times/week), 2=sometimes (2-4 times/week), and 1=rarely (≤1 time/week); for items 31 and 32, 3=fall asleep, 2=very sleepy, 1=not sleepy. A score of 3 indicates greater severity; however, 6 items (1-Goes to bed at same time; 3-Falls asleep in own bed; 26-Wakes by himself; 2-Falls asleep in 20 minutes; 10-Sleeps the right amount; 11-Sleeps same amount each day) are reverse scored. The total summed score ranges from 33 to 99, with higher scores indicating disturbed sleep behavior. A negative mean change from baseline indicates improvement in sleep." (NCT04252586)
Timeframe: Baseline of randomized controlled trial (RCT) Visit 1 (Day 1) up to Visit 14 (Day 729) in the OLE

Interventionunits on a scale (Mean)
GWP42003-P-3.0

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Mean Clinician Global Impressions - Severity Scale (CGI-S) Continuous Score at End of Treatment

CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment relative to the clinician's experience with participants who had the same diagnosis. This was rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 =severely ill; or 7 = extremely ill. The mean continuous CGI-S score (averaged from each treatment enrolled under protocol and under annex) at Visit 14 (Day 729) is being reported. Higher scores indicate more severe disease. (NCT04252586)
Timeframe: Visit 14 (Day 729) in the OLE

Interventionscore on a scale (Mean)
GWP42003-P4.3

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Total Urinary Symptoms Score

Patient self-reported urinary symptoms measured by the Ureteric Stent Symptoms Questionnaire (USSQ) urinary symptoms section. Following insertion of the stents, subjects were asked to answer 11 questions regarding their urinary symptoms. 9 questions used a score of 1 to 5, where 1 was never and 5 was all of the time. 1 question used a score of 1 to 4, where 1 was do not see any blood and 4 was urine is heavily blood stained. 1 question used a score of 1 to 7, where 1 was delighted and 7 was terrible. Total sum of all 11 questions for a total score ranging from 11 - 56, lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction. (NCT04387617)
Timeframe: postoperative day 1 and postoperative day 3

,
Interventionscore on a scale (Mean)
Postoperative day 1Postoperative day 3
CBD Oil Group3127
Control Group3327

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The Number of Subjects With Adverse Events

The count of subjects who experienced adverse events (NCT04387617)
Timeframe: 3 days post-ureteroscopy

,
InterventionParticipants (Count of Participants)
NauseaConstipationDiarrheaPoor appetitePoor sleepDrowinessDizzinessTirednessItchingHeadache
CBD Oil Group31038111171724
Control Group29145851324

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Postoperative Rescue Narcotic Use

The number of subjects who required rescue narcotic use post ureteroscopy (NCT04387617)
Timeframe: postoperative Day 3

InterventionParticipants (Count of Participants)
CBD Oil Group8
Control Group9

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Maximum Pain Intensity Score

Patient self-reported maximum pain intensity score measured by the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. (NCT04387617)
Timeframe: postoperative Day 3

Interventionscore on a scale (Mean)
CBD Oil Group3.6
Control Group3.2

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Neuroscore

Data on neurological function was collected using the Neuroscore. Data on frequency of seizures, extent of hemiparesis, assessment of visual field cut, and degree of cognitive functioning was transformed into a score from 0 to 15 where higher scores indicate worse neurologic function. Data was collected at baseline and 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Mean Seizure ScoreFollow-Up Mean Seizure ScoreBaseline Mean Hemiparesis ScoreFollow-Up Mean Hemiparesis ScoreBaseline Mean Visual Field Cut ScoreFollow-Up Mean Visual Field Cut ScoreBaseline Mean Cognitive Function ScoreFollow-up Mean Cognitive Function ScoreBaseline Mean Composite ScoreFollow-up Mean Composite Score
Cannabidiol/ Epidiolex1.111.001.441.000.110.002.331.445.003.44

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Modified House Classification Scores

Data on motor function was collected using a Modified House Classification. Data was collected on the ability to complete a task with the subject's non-dominant hand which was transformed into a score from 1 to 8 and 0 to 32 where higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Mean Highest Category in Which All Items were Successfully CompletedFollow-up Mean Highest Category in Which All Items were Successfully CompletedBaseline Mean Total Number of Items Successfully CompletedFollow-up Mean Total Number of Items Successfully Completed
Cannabidiol/ Epidiolex5.115.4426.6727.44

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Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

Data on executive function was collected using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). Data on the frequency of an event (e.g. becomes upset too easily) was collected and transformed into a t-score. The following BRIEF-2 subtests were evaluated: Behavioral Regulation Index, Emotional Regulation Index, Cognitive Regulation Index, and Global Executive Composite. For each BRIEF-2 subtest, t-scores range from 0 to 100; a score of 50 indicates the population mean with a standard deviation of 10. For all BASC-3 subtests, higher scores are worse outcome. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionT-score (Mean)
Baseline Mean for Behavioral Regulation IndexFollow-Up Mean for Behavioral Regulation IndexBaseline Mean for Emotional Regulation IndexFollow-up Mean for Emotional Regulation IndexBaseline Mean for Cognitive Regulation IndexFollow-up Mean for Cognitive Regulation IndexBaseline Mean for Global Executive CompositeFollow-up Mean for Global Executive Composite
Cannabidiol/ Epidiolex55.1152.4460.2251.2254.1154.2256.7853.33

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Safety of Epidiolex

Safety of Epidiolex was measured by the number of adverse events and serious adverse events that result from study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionEvents (Number)
Number of Adverse Events that Resulted from the Study DrugNumber of Serious Adverse Events that Resulted from the Study Drug
Cannabidiol/ Epidiolex240

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Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55)

Data on quality of life was collected using the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55). Data on the frequency of an event (e.g. had trouble concentrating on a task) was collected and transformed into a score from 0 to 100 where higher scores reflect better quality of life. Data was collected at baseline and 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Mean Total ScoreFollow-up Mean Total Score
Cannabidiol/ Epidiolex61.1771.39

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Port-wine Birthmark Score

Data on facial port-wine birthmarks was collected using the Port-wine Birthmark Score. Data on percent of face covered, thickness of birthmark, and darkness of birthmark color was collected and transformed into a score from 0 to 43 where higher scores indicate greater severity and greater surface area involved. Data was collected at baseline and 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Mean Total ScoreFollow-up Mean Total Score
Cannabidiol/ Epidiolex8.568.11

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Picture Vocabulary Test

Data on cognitive function was collected using the Picture Vocabulary subtest from the NIH Toolbox. Single words are presented via an audio file, paired simultaneously with 4 screen images of objects, actions, and/or depictions of concepts. The task is to pick the picture that matches the spoken word. Performance on the task was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionT-score (Mean)
Baseline Mean of the Fully Adjusted Picture Vocabulary ScoreFollow-up Mean of the Fully Adjusted Picture Vocabulary Score
Cannabidiol/ Epidiolex42.8842.38

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Pediatric Neurological Quality of Life (Neuro-QoL)

Data on cognitive function was collected using Neurological Quality of Life scales from the NIH Toolbox. Data on frequency of an event (e.g. forgetting schoolwork) was collected and transformed into a t-score from 0 to 100 where higher t-scores indicate worse anger, worse anxiety, worse pain, better social relationships, worse stigma, worse depression, better cognitive function, and worse fatigue. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionT-score (Mean)
Baseline Mean Pediatric Score for AngerFollow-up Mean Pediatric Score for AngerBaseline Mean Pediatric Score for AnxietyFollow-up Mean Pediatric Score for AnxietyBaseline Mean Pediatric Score for PainFollow-up Mean Pediatric Score for PainBaseline Mean Pediatric Score for Social RelationsFollow-up Mean Pediatric Score for Social RelationsBaseline Mean Pediatric Score for StigmaFollow-up Mean Pediatric Score for StigmaBaseline Mean Pediatric Score for DepressionFollow-up Mean Pediatric Score for DepressionBaseline Mean Pediatric Score for Cognitive FunctionFollow-up Mean Pediatric Score for Cognitive FunctionBaseline Mean Pediatric Score for FatigueFollow-up Mean Pediatric Score for Fatigue
Cannabidiol/ Epidiolex53.0249.6745.2041.0740.2043.5043.2854.3342.4544.5244.0744.6249.2751.3346.3845.97

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Pediatric Evaluation of Disability Inventory Computer Adapted Test

Data on motor function was collected using the Pediatric Evaluation of Disability Inventory Computer Adapted Test. Data was collected on the subject's ability to complete tasks involved in daily activities, mobility, and social/ cognitive activities. The data was transformed into scaled scores ranging from 20 to 80, where higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Mean Score for Daily ActivitiesFollow-up Mean Score for Daily ActivitiesBaseline Mean Score for MobilityFollow-Up Mean Score for MobilityBaseline Mean Score for ResponsibilityFollow-Up Mean Score for ResponsibilityBaseline Mean Score for Social CognitiveFollow-up Mean Score for Social Cognitive
Cannabidiol/ Epidiolex58.6760.0067.1168.5652.4453.8966.8967.22

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ABILHAND Questionnaire

Data on motor function was collected using the ABILHAND questionnaire, a measure of manual ability for adults with upper limb impairments. Data was collected on the subject's ability to complete daily activities that involve the upper limbs. Score was collected as a patient measure with scores ranging from -10 to 10. Higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Mean of the ABILHANDFollow-up Mean of the ABILHAND
Cannabidiol/ Epidiolex1.812.88

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Adult Neurological Quality of Life (Neuro-QoL)

Data on cognitive function was collected using Neurological Quality of Life scales from the NIH Toolbox. Data on frequency of an event was collected and transformed into a t-score from 0 to 100. Higher t-scores indicate better communication, better ability to participate in social activity, worse anxiety, worse depression, worse emotional and behavioral dyscontrol, worse fatigue, better positive affect, worse sleep disturbance, better lower and upper extremity functions, worse stigma, better satisfaction with social roles, and better cognitive function. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionT-score (Mean)
Baseline Mean Adult Score for AnxietyFollow-Up Mean Adult Score for AnxietyBaseline Mean Adult Score for DepressionFollow-Up Mean Adult Score for DepressionBaseline Mean Adult Score for FatigueFollow-Up Mean Adult Score for FatigueBaseline Mean Adult Score for Upper Extremity FunctionFollow-Up Mean Adult Score for Upper Extremity FunctionBaseline Mean Adult Score for Lower Extremity FunctionFollow-Up Mean Adult Score for Lower Extremity FunctionBaseline Mean Adult Score for Cognitive FunctionFollow-Up Mean Adult Score for Cognitive FunctionBaseline Mean Adult Score for Emotional and Behavioral DyscontrolFollow-Up Mean Adult Score for Emotional and Behavioral DyscontrolBaseline Mean Adult Score for Well-beingFollow-Up Mean Adult Score for Well-beingBaseline Mean Adult Score for Sleep DisturbancesFollow-Up Mean Adult Score for Sleep DisturbancesBaseline Mean Adult Score for Participation in Social ActivitiesFollow-Up Mean Adult Score for Participation in Social ActivitiesBaseline Mean Adult Score for Satisfaction in Social ActivitiesFollow-Up Mean Adult Score for Satisfaction in Social ActivitiesBaseline Mean Adult Score for StigmaFollow-Up Mean Adult Score for Stigma
Cannabidiol/ Epidiolex46.7746.8742.7044.2345.2342.8048.9753.8058.6058.6047.0346.7351.1041.3754.3055.7047.0343.9353.0051.0347.7049.2353.9056.47

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Behavioral Assessment System for Children, Third Edition (BASC-3)

Data on behavioral function was collected using the Behavioral Assessment System for Children, Third Edition (BASC-3). Data on the frequency of a behavior (e.g. avoids eye contact) was collected and transformed into a t-score. Subscales for the BASC-3 scored were: External Problems Composite, the Internal Problems Composite, the Behavioral Symptoms Index, and the Adaptive Skills Composite. For the first three subscales, lower t-score indicates better outcome; for the fourth, a lower t-score indicates worse outcome. T-scores for all the BASC-3 subscales range from 0 to 100, and a t-score of 50 indicates the population mean with a standard deviation of 10. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionT-score (Mean)
Baseline Mean External Problems CompositeFollow-up Mean External Problems CompositeBaseline Mean Internal Problems CompositeFollow-Up Mean Internal Problems CompositeBaseline Mean Behavioral Symptoms IndexFollow-up Mean Behavioral Symptoms IndexBaseline Mean Adaptive Skills CompositeFollow-Up Mean Adaptive Skills Composite
Cannabidiol/ Epidiolex51.2250.1152.2246.2254.2250.1145.0048.44

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Erhardt Developmental Prehension Assessment Scores

Data on motor function was collected using the Erhardt Developmental Prehension assessment. Data was collected on the ability to complete a task with each hand, which was scored as age equivalence of task performance (in months). Higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionMonths (Mean)
Baseline Mean Dominant Hand Total ScoreFollow-up Mean Dominant Hand Total ScoreBaseline Mean Non-Dominant Hand Total ScoreFollow-up Mean Non-Dominant Hand Total Score
Cannabidiol/ Epidiolex54.2253.5651.2253.78

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List Sorting Working Memory Test

Data on cognitive function was collected using the List Sorting Working Memory Test from the NIH Toolbox. Data was collected on working memory performance, which was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionT-score (Mean)
Baseline List Sorting Working Memory Fully Adjusted ScoreFollow-Up List Sorting Working Memory Fully Adjusted Score
Cannabidiol/ Epidiolex37.1439.14

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Migraine Severity

Data on migraine severity will be collected using patient responses to questions on a standard six-point scale. Data will be collected on the frequency of an event (e.g. feelings of frustration, performance of daily activities) which will be transformed into a score from 0 to 100 where higher scores indicate a less migraine severity and better outcomes. Data will be collected at baseline and after 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Mean Migraine-Quality of Life ScoreFollow-up Mean Migraine-Quality of Life Score
Cannabidiol/ Epidiolex96.8397.50

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Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV)

"Data on cognitive function was collected using selected subtests, from either the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale (WAIS-IV). For the WISC-V and WAIS-IV subtests selected, scaled scores were derived from the normative data which account for age and demographic information. The selected WISC-V/WAIS-IV subtests were as follows: Digit Span, Symbol Search, Coding and Processing Speed; the first three subtests were scored from 0-10, the fourth subtest from 0-100, and for all subtests higher score is better. The selected subtests, from the WISC-V and the WAIS-IV, were combined to increase statistical power.~Statistically rare changes in individual test scores were determined using a reliable change index methodology based upon normative information for these assessments." (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Mean Digit Span ScoreFollow-up Mean Digit Span ScoreBaseline Mean Symbol Search ScoreFollow-up Mean Symbol Search ScoreBaseline Mean Coding ScoreFollow-up Mean Coding ScoreBaseline Mean Processing Speed ScoreFollow-up Mean Processing Speed Score
Cannabidiol/ Epidiolex5.716.436.005.575.574.7177.1473.43

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Social Responsiveness Scale, Second Edition (SRS-2)

Data on social function was collected using the Social Responsiveness Scale-Second Edition (SRS-2). Data on a child's ability to engage in emotionally appropriate reciprocal social interactions in naturalistic settings was collected and transformed into a t-score from 0 to 100 where higher scores indicate greater impairment in social function. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

InterventionT-score (Mean)
Baseline Mean Total ScoreFollow-up Mean Total Score
Cannabidiol/ Epidiolex54.2249.22

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Seizure Frequency

Change in seizure frequency by seizure score at pre-treatment baseline and after six months. The seizure score is taken from the Sturge-Weber Neuroscore on a scale of 0 to 4 where 0=none, 1=1+. but controlled, 2=Breakthrough, 3=monthly, 4=Weekly+. Higher scores indicate worse outcome. (NCT04447846)
Timeframe: Baseline, Follow-up (6 months)

Interventionscore on a scale (Mean)
Baseline Seizure Score from Sturge-Weber NeuroscoreFollow-up Seizure Score from Sturge-Weber Neuroscore
Cannabidiol/ Epidiolex1.111.00

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Change in Baseline VAMS--Physical Sedation

Visual Analog Mood Scale (VAMS). Physical sedation: sum of scores from questions 3, 5, 6, 16 on VAMS - higher scores indicate more physical sedation. Total min=0 Total max=400 (NCT04590495)
Timeframe: 4 hours after baseline

Interventionscore on a scale (Mean)
300 mg Cannabidiol (CBD) Oil135.6
Placebo152.7

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Change in Baseline VAMS for Mental Sedation

Visual Analog Mood Scale (VAMS). Mental sedation: sum of scores from questions 1, 4, 11, 13 on VAMS - higher scores indicate more mental sedation. Total min=0 Total max=400 (NCT04590495)
Timeframe: 4 hours after baseline

Interventionscore on a scale (Mean)
300 mg Cannabidiol (CBD) Oil148.7
Placebo161.3

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Change in Baseline TMT Part B

Trail Making Test (TMT). Time to accurately complete Part B. The TMT measures executive function and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment. (NCT04590495)
Timeframe: 4 hours after baseline

InterventionSeconds (Mean)
300 mg Cannabidiol (CBD) Oil29.7
Placebo37.1

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Change in Baseline TMT Part A

Trail Making Test (TMT). Time to accurately complete Part A . The TMT measures executive function and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment. (NCT04590495)
Timeframe: 4 hours after baseline

InterventionSeconds (Mean)
300 mg Cannabidiol (CBD) Oil14.2
Placebo15.6

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Driving Performance - Number of Collisions.

From driving simulation. A greater number of collisions indicate worse performance. Min=0 max=infinity (NCT04590495)
Timeframe: 1.5 hour post intervention

InterventionNumber of collisions (Mean)
300 mg Cannabidiol (CBD) Oil0.90
Placebo0.68

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Change in Baseline SRT for Sound #1

Simple Reaction Time test (SRT). Mean reaction time to stimuli that appears on a computer screen. Longer reaction times mean a decrease in reaction time. Min=0 max=infinity. Two separate sounds were emitted. Data were obtained for participants reaction to each separate sound (NCT04590495)
Timeframe: 4 hours after baseline

Interventionmilliseconds (Mean)
300 mg Cannabidiol (CBD) Oil241.4
Placebo244.6

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Change in Baseline SSS

Stanford Sleepiness Scale (SSS). Self-reported sleepiness, The SSS is a Likert-type scale which assess mental and physical sedation and sleepiness, respectively, at that moment and time. SSS only consists of 1 question that is scaled from 1 to 7, with 7 being a higher or worse score (i.e. more sleepy and sedated) (NCT04590495)
Timeframe: 4 hours after baseline

Interventionunits on a scale (Mean)
300 mg Cannabidiol (CBD) Oil2.67
Placebo2.63

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Change in Baseline SRT--sound #2

Simple Reaction Time test (SRT). Mean reaction time to stimuli that appears on a computer screen. Longer reaction times mean a decrease in reaction time. Min=0 max=infinity. Two separate sounds were emitted. Data were obtained for participants reaction to each separate sound (NCT04590495)
Timeframe: 4 hours after baseline

Interventionmilliseconds (Mean)
300 mg Cannabidiol (CBD) Oil239.6
Placebo240.4

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Change in Baseline PVT

Psychomotor Vigilance Test (PVT). Mean reaction time (in milliseconds) when responding to a stimuli that appears on a computer screen. Longer reaction time means worse vigilance. Min=0 max=infinity (NCT04590495)
Timeframe: 4 hours after baseline

Interventionmilliseconds (Mean)
300 mg Cannabidiol (CBD) Oil331.7
Placebo330.0

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Change in Baseline DSST

Digital Symbol Substitution Test (DSST). Number of correct symbols completed within 60 seconds. The test is scored by the degree of completion and accuracy over a timed 60 second period. More accurate completion (i.e. higher the score) indicates better cognitive functioning. Min=0 Max=90 (NCT04590495)
Timeframe: 4 hours after baseline

InterventionNumber of correct symbols (Mean)
300 mg Cannabidiol (CBD) Oil74.5
Placebo71.8

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Driving Performance - Lateral Position in Lane

Mean standard deviation of lateral position in lane under consistent speed from driving simulation. Larger standard deviations in lane position indicate worse performance. Min=0 max=infinity (NCT04590495)
Timeframe: 1.5 hour post intervention

InterventionFeet (Mean)
300 mg Cannabidiol (CBD) Oil4.37
Placebo3.88

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Driving Performance-percent of Time Spent Driving Above Speed Limit

From driving simulation. This is the percent of drive time that the driver spent driving above the speed limit. Greater percentage indicates worse performance. (NCT04590495)
Timeframe: 1.5 hour post intervention

InterventionPercent time driving over speed limit (Mean)
300 mg Cannabidiol (CBD) Oil5.83
Placebo8.27

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Driving Performance - Brake Reaction Time

Mean reaction time to stimuli from driving simulation. Longer reaction times indicate worst performance. Min=0 max=infinity (NCT04590495)
Timeframe: 1.5 hour post intervention

InterventionSeconds (Mean)
300 mg Cannabidiol (CBD) Oil0.60
Placebo0.58

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Driving Performance - Percent of Time Spent Out of Lane

From driving simulation. A greater percentage of time spent driving out of lane indicates worse performance. Min=0 max=100% (NCT04590495)
Timeframe: 1.5 hour post intervention

InterventionPercent time spent driving out of lane (Mean)
300 mg Cannabidiol (CBD) Oil4.41
Placebo4.34

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Attentional Bias

Visual probe task will be used to assess attentional bias to drug-related cues. Opioid-related and neutral images will be used. Each trial will begin with a fixation point lasting 500ms. A pair of images then will appear on the left and right of the screen for either a short (200ms) or long (500ms) stimulus duration to assess automatic orientating and controlled attention processing, respectively. Image pairs will be replaced by a probe in the location of either the opioid-related or neutral image. The probe will remain until the participant responds to identify the probe orientation by pressing the response keys as quickly as possible. Attentional bias is calculated as the difference in reaction time (RT) between when the probe replaced the neutral compared with the opioid-related images (i.e. RTneutral - RTopioid). Therefore the more positive the number, the less attentional bias toward drug cue, and a negative number represents more attentional bias toward the drug cue. (NCT04982029)
Timeframe: Visit 2 and 3 (at least 1 week apart)

,
Interventionmiliseconds (Mean)
Automatic orientingControlled attention
Cannabidiol 600mg-80.4145.2
Placebo100.3-93.1

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Stress-Reactivity (Physiological)

For this outcome, participants received a salivary cortisol test prior to, immediately after, and 20 minutes after the cue-reactivity paradigm. Lower levels indicate lower levels of salivary cortisol in the sample. (NCT04982029)
Timeframe: Visit 2 and 3 (at least 1 week apart)

,
Interventionmcg/dL (Mean)
Pre-ParadigmPost-Paradigm20 Minutes Post Paradigm
Cannabidiol 600mg0.08550.07450.0828
Placebo Session0.15420.08160.0806

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Change in Cue-reactivity

The primary outcomes is cue-induced cravings (Opioid Craving Scale). This was measured with a single 10-point likert scale asking about cravings, where 0 represented lower levels of craving and 10 indicated higher levels of cravings. This was given at 3 different time points, pre-cue, post-neutral, and post-drug images. Cue-induced craving is the difference between drug cue and pre-cue scores. (NCT04982029)
Timeframe: Visit 2 and 3 (at least 1 week apart)

,
Interventionscore on a scale (Mean)
Pre-cuePost-drug cuePost-neutral cueCue-induced craving
Cannabidiol 600mg0.70.90.50.2
Placebo1.12.41.11.3

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Stress-reactivity

Physiologic and subjective stress will be assessed. Stress-reactivity was measured by participants mirror tracing an image on a compute screen where a loud beeping noise would occur if a participant took too long or went outside the lines. It's measured in ms and the longer someone stayed on the task, the better ability they have to react stress. (NCT04982029)
Timeframe: Visit 2 and 3 (at least 1 week apart)

Interventionmiliseconds (Mean)
Cannabidiol 600mg59.00
Placebo Session99.83

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Delayed Discount

Monetary Choice Questionnaire will be used to calculate impulse decision making. This is a 27-item self-administered questionnaire where participants choose between a smaller, immediate monetary reward and a larger, delayed monetary reward. A participants score is between one of the two endpoints (0.25 or 0.00016). If an individual is more likely to prefer the delayed versus immediate reward, their score is more likely to be closer to the 0.00016 endpoint. Please note the rate of delayed discounting is not the same for each question. (NCT04982029)
Timeframe: Visit 2 and 3 (at least 1 week apart)

Interventionunits on a scale (Mean)
Cannabidiol 600mg0.020
Placebo0.039

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Decision Making

"Iowa Gambling Task will be used to assess impulsive decision-making. The larger the number, the more safer options were chosen. This is measured by taking the total number of risky choices and subtracting it from the less risky choices. The lower the number, the more high risky options were chosen. If participants chose the less risky option, they received a positive point, if individuals picked the riskier choice, they received a negative point. Negative values indicate a participant chose more riskier decisions than less-risky, whereas positive values indicate participants chose the less riskier decision more often. The lowest score an individual could receive is -100 (very risk) to 100 (least risky)." (NCT04982029)
Timeframe: Visit 2 and 3 (at least 1 week apart)

Interventionunits on a scale (Mean)
Cannabidiol 600mg.2.2
Placebo-6.4

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Number of Differentially Expressed Genes

Number of genes with a significant fold change before/after CBD in PBMCs (Peripheral Blood Mononuclear Cells) related to inflammation genes, calculated before and after CBD treatment (baseline and 1 month for 1 participant, 2 months for 2 participants). (NCT05209867)
Timeframe: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)

InterventionDifferentially expressed genes (Mean)
CBD Intervention8.3

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