Page last updated: 2024-12-10

nabilone

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Description

nabilone: cannabinol deriv; RN given refers to cpd without isomeric designation; structure [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5284592
CHEMBL ID947
SCHEMBL ID33339
MeSH IDM0058596

Synonyms (59)

Synonym
(6ar,10ar)-3-(1,1-dimethylheptyl)-1-hydroxy-6,6-dimethyl-6,6a,7,8,10,10a-hexahydro-9h-benzo[c]chromen-9-one
(+-)-3-(1,1-dimethylheptyl)-6,6abeta,7,8,10,10aalpha-hexahydro-1-hydroxy-6,6-dimethyl-9h-dibenzo(b,d)pyran-9-one
nabilonum [latin]
9h-dibenzo(b,d)pyran-9-one, 3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-, (6ar,10ar)-rel-
nabilone [usan:inn:ban]
dea no. 7379
(+-)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9h-dibenzo(b,d)pyran-9-one
nabilona [spanish]
9h-dibenzo(b,d)pyran-9-one, 3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-, trans-, (+-)-
51022-71-0
cesamet (tn)
nabilone (usan/inn)
D05099
nabilone
DB00486
CHEMBL947 ,
bdbm50287941
(6ar,10ar)-1-hydroxy-6,6-dimethyl-3-(2-methyloctan-2-yl)-7,8,10,10a-tetrahydro-6h-benzo[c]chromen-9(6ah)-one
(6ar,10ar)-3-(1,1-dimethyl-heptyl)-1-hydroxy-6,6-dimethyl-6,6a,7,8,10,10a-hexahydro-benzo[c]chromen-9-one
cpd-109514
(6ar,10ar)-1-hydroxy-6,6-dimethyl-3-(2-methyloctan-2-yl)-7,8,10,10a-tetrahydro-6ah-benzo[c]chromen-9-one
nabilona
2n4o9l084n ,
unii-2n4o9l084n
(+-)-trans-3-(1,1-dimethylheptyl)-6a,7,8,9,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-6h-dibenzo(b,d)pyran-9-on
cpd 109514
(+-)-trans-3-(1,1-dimethylheptyl-7,8,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-6h-dibenzo(b,d)pyran-9(6ah)-on
nabilonum
nabilone [who-dd]
nabilone [mart.]
(+/-)-3-(1,1-dimethylheptyl-6,6a.beta.,7,8,10,10a.alpha.-hexahydro-1-hydroxy-6,6-dimethyl-9h-dibenzo(b,d)pyran-9-one
nabilone [inn]
nabilone [usan]
9h-dibenzo(b,d)pyran-9-one, 3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-, trans-, (+/-)-
nabilone [mi]
nabilone [vandf]
nabilone [orange book]
SCHEMBL33339
N-0100
(-)-trans-1-hydroxy-3-(1,1-dimethylheptyl)-6,6-dimethyl-6,6a,7,8,10,10a-hexahydro-9h-dibenzo[b,d]-pyran-9-one
(-)-trans-1-hydroxy-3-(1,1-dimethylheptyl)-6,6-dimethyl-6,6a,7,8,10,10a-hexahydro-9h-dibenzo[b,d]pyran-9-one
trans-1-hydroxy-3-(1,1-dimethylheptyl)-6,6-dimethyl-6,6a,7,8,10,10a-hexahydro-9h-dibenzo[b,d]-pyran-9-one
trans-3-(1',1'-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9h-dibenzo[b,d]pyran-9-one
trans-1-hydroxy-3-(1,1-dimethylheptyl)-6,6-dimethyl-6,6a,7,8,10,10a-hexahydro-9h-dibenzo[b,d]pyran-9-one
9h-dibenzo[b,d]pyran-9-one, 3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-, (6ar,10ar)-rel-
DTXSID8023341 ,
(6ar,10ar)-1-hydroxy-6,6-dimethyl-3-(2-methyloctan-2-yl)-6h,6ah,7h,8h,9h,10h,10ah-benzo[c]isochromen-9-one
(-)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9h-dibenzo[b,d]pyran-9-one
nabilone, solid, >=98% (hplc)
Q419079
DTXSID401015800
(-)-nabilone
61617-09-2
a04ad11
nabilon
nabilone (mart.)
dtxcid501473954
(+/-)-3-(1,1-dimethylheptyl-6,6abeta,7,8,10,10aalpha-hexahydro-1-hydroxy-6,6-dimethyl-9h-dibenzo(b,d)pyran-9-one
nabilonum (latin)

Research Excerpts

Overview

Nabilone is a synthetic cannabinoid prescription drug approved in Canada since 1981 to treat chemotherapy-induced nausea and vomiting. Nabilone appears to be a beneficial, well-tolerated treatment option for fibromyalgia patients, with significant benefits in pain relief and functional improvement.

ExcerptReferenceRelevance
"Nabilone is an adequate and safe therapeutic option to aid in the treatment of patients diagnosed with anorexia. "( The effect of nabilone on appetite, nutritional status, and quality of life in lung cancer patients: a randomized, double-blind clinical trial.
Arrieta, O; Barrón, F; Del Rocío Guillen Núñez, M; Flores-Estrada, D; Oñate-Ocaña, LF; Turcott, JG; Zatarain-Barrón, ZL, 2018
)
2.28
"Nabilone is a synthetic cannabinoid that has shown promise for the treatment of posttraumatic stress disorder (PTSD)-related insomnia and nightmares as well as efficacy in the management of chronic pain. "( Use of a synthetic cannabinoid in a correctional population for posttraumatic stress disorder-related insomnia and nightmares, chronic pain, harm reduction, and other indications: a retrospective evaluation.
Cameron, C; Robinson, J; Watson, D, 2014
)
1.85
"Nabilone is a synthetic cannabinoid with properties that make it an appealing candidate as a postoperative nausea and vomiting (PONV) prophylactic adjunct. "( A randomized-controlled trial of nabilone for the prevention of acute postoperative nausea and vomiting in elective surgery.
Chan, AW; Dulberg, Z; Hare, GM; Hong, A; Levin, DN; Mazer, CD, 2017
)
2.18
"Nabilone is a synthetic cannabinoid prescription drug approved in Canada since 1981 to treat chemotherapy-induced nausea and vomiting. "( The abuse potential of the synthetic cannabinoid nabilone.
St Arnaud-Trempe, E; Ware, MA, 2010
)
2.06
"Nabilone is a synthetic cannabinoid licensed in Canada for the treatment of severe nausea and vomiting associated with cancer chemotherapy."( Experience with the synthetic cannabinoid nabilone in chronic noncancer pain.
Berlach, DM; Shir, Y; Ware, MA,
)
1.12
"Nabilone appears to be a beneficial, well-tolerated treatment option for fibromyalgia patients, with significant benefits in pain relief and functional improvement."( Nabilone for the treatment of pain in fibromyalgia.
Ethans, K; Galimova, L; Perry, D; Skrabek, RQ, 2008
)
2.51
"Nabilone is an effective oral anti-emetic drug for moderately toxic chemotherapy, but the range and unpredictability of its side-effects warrant caution in its use."( Anti-emetic efficacy and toxicity of nabilone, a synthetic cannabinoid, in lung cancer chemotherapy.
Ahmedzai, S; Calder, IT; Carlyle, DL; Moran, F, 1983
)
1.26
"Nabilone is a cannabinoid anti-emetic which has been extensively evaluated in control of chemotherapy-induced vomiting. "( An initial evaluation of Nabilone in the control of radiotherapy-induced nausea and vomiting.
Priestman, SG; Priestman, TJ, 1984
)
2.01
"Nabilone is a cannabinol derivative which has potent central antiemetic effects in animals. "( Nabilone: a potent antiemetic cannabinol with minimal euphoria.
Dean, J; Dorr, R; Herman, TS; Jones, SE; Leigh, S; Moon, TE; Salmon, SE, 1977
)
3.14
"Nabilone is a cannabinoid that is being evaluated in man as a potentially useful psychoactive drug. "( Physiologic disposition of nabilone, a cannabinol derivative, in man.
Crabtree, RE; Lemberger, L; Obermeyer, BD; Rowe, H; Rubin, A; Sullivan, H; Warrick, P, 1977
)
2
"Nabilone is a modified cannabinol derivative with central nervous system activity. "( Clinical pharmacology of nabilone, a cannabinol derivative.
Lemberger, L; Rowe, H, 1975
)
2
"Nabilone is a new orally active cannabinoid for the treatment of severe gastrointestinal toxicity associated with cancer chemotherapy. "( Nabilone. A preliminary review of its pharmacological properties and therapeutic use.
Holmes, B; Ward, A, 1985
)
3.15
"Nabilone appears to be a safe, effective, and well-tolerated antiemetic drug for children receiving cancer chemotherapy."( Nabilone versus prochlorperazine for control of cancer chemotherapy-induced emesis in children: a double-blind, crossover trial.
Chan, HS; Correia, JA; MacLeod, SM, 1987
)
2.44

Effects

Nabilone is approved to treat chemotherapy-induced nausea and vomiting. Nabilone has many properties that could alleviate symptoms caused by radiotherapy and improve patients' quality of life.

ExcerptReferenceRelevance
"Nabilone has been best studied for the treatment of nausea secondary to cancer chemotherapy."( Medical marijuana for cancer.
Kramer, JL, 2015
)
1.14
"Nabilone has many properties that could alleviate symptoms caused by radiotherapy and improve patients' quality of life."( Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial.
Côté, M; Fortin, A; Trudel, M; Wang, C, 2016
)
1.44
"Nabilone has proven clinical utility in chemotherapy-related nausea and vomiting but has not been adequately tested for PONV."( A randomized-controlled trial of nabilone for the prevention of acute postoperative nausea and vomiting in elective surgery.
Chan, AW; Dulberg, Z; Hare, GM; Hong, A; Levin, DN; Mazer, CD, 2017
)
1.46
"Nabilone has been approved to treat chemotherapy-induced nausea and vomiting. "( Oral nabilone capsules in the treatment of chemotherapy-induced nausea and vomiting and pain.
Davis, MP, 2008
)
2.3
"Nabilone has proven to be more effective in controlling symptoms and preferred by more patients than prochlorperazine 10mg 2 to 4 times daily in a limited number of studies, despite a higher incidence of side effects."( Nabilone. A preliminary review of its pharmacological properties and therapeutic use.
Holmes, B; Ward, A, 1985
)
2.43

Actions

Nabilone failed to produce analgesic effects. It did not interact with descending pain inhibitory systems. Nabilone tended to increase the number of abnormal spermatozoa.

ExcerptReferenceRelevance
"Nabilone failed to produce analgesic effects and it did not interact with descending pain inhibitory systems. "( Analgesic and antihyperalgesic effects of nabilone on experimental heat pain.
Goffaux, P; Marchand, S; Potvin, S; Redmond, WJ, 2008
)
2.05
"Nabilone tended to increase the number of abnormal spermatozoa, but this did not reach statistical significance."( Effect of the synthetic cannabinoid nabilone on spermatogenesis in mice.
Patra, PB; Wadsworth, RM, 1990
)
1.28

Treatment

ExcerptReferenceRelevance
"Nabilone treatment of rats and dogs for 3 months produced no evidence of systemic toxicity in the clinical chemistry, hematology, or pathology parameters examined."( A species comparison of the toxicity of nabilone, a new synthetic cannabinoid.
Emmerson, JL; Gries, CL; Hanasono, GK; Jordan, WH; Sullivan, HR, 1987
)
1.26

Toxicity

The oral LD50 in mice and rats for nabilone formulated as a polyvinylpyrrolidone (PVP) codispersion was in excess of 1000 mg/kg. Adverse effects common with nabilon were drowsiness (57%), postural dizziness (35%) and lightheadedness (18%).

ExcerptReferenceRelevance
" The oral LD50 in mice and rats for nabilone formulated as a polyvinylpyrrolidone (PVP) codispersion was in excess of 1000 mg/kg."( A species comparison of the toxicity of nabilone, a new synthetic cannabinoid.
Emmerson, JL; Gries, CL; Hanasono, GK; Jordan, WH; Sullivan, HR, 1987
)
0.82
" Adverse effects common with nabilone were drowsiness (57%), postural dizziness (35%) and lightheadedness (18%)."( Anti-emetic efficacy and toxicity of nabilone, a synthetic cannabinoid, in lung cancer chemotherapy.
Ahmedzai, S; Calder, IT; Carlyle, DL; Moran, F, 1983
)
0.83
" Adverse effects associated with nabilone use were noted."( Safety and efficacy of nabilone for acute chemotherapy-induced vomiting prophylaxis in pediatric patients: A multicenter, retrospective review.
Dupuis, LL; Jupp, J; Khanna, M; MacDonald, T; Ning, W; Patel, P; Polito, S; Romanick, M; Sung, L; Vennettilli, A; Wiernikowski, J, 2018
)
1.07
" Adverse effects associated with nabilone were experienced by 34% (37/110) of children."( Safety and efficacy of nabilone for acute chemotherapy-induced vomiting prophylaxis in pediatric patients: A multicenter, retrospective review.
Dupuis, LL; Jupp, J; Khanna, M; MacDonald, T; Ning, W; Patel, P; Polito, S; Romanick, M; Sung, L; Vennettilli, A; Wiernikowski, J, 2018
)
1.07

Compound-Compound Interactions

Zolpidem alone and in combination with nabilone decreased withdrawal-related disruptions in mood and food intake relative to placebo.

ExcerptReferenceRelevance
"This placebo-controlled study examined the effects of zolpidem alone and in combination with nabilone on cannabis withdrawal and a laboratory measure of relapse."( Effects of zolpidem alone and in combination with nabilone on cannabis withdrawal and a laboratory model of relapse in cannabis users.
Bedi, G; Comer, SD; Cooper, ZD; Foltin, RW; Haney, M; Herrmann, ES; Ramesh, D; Reed, SC, 2016
)
0.91
"Both medication conditions decreased withdrawal-related disruptions in sleep, but only zolpidem in combination with nabilone decreased withdrawal-related disruptions in mood and food intake relative to placebo."( Effects of zolpidem alone and in combination with nabilone on cannabis withdrawal and a laboratory model of relapse in cannabis users.
Bedi, G; Comer, SD; Cooper, ZD; Foltin, RW; Haney, M; Herrmann, ES; Ramesh, D; Reed, SC, 2016
)
0.9
"Clinical testing of nabilone, either alone, or in combination with zolpidem is warranted."( Effects of zolpidem alone and in combination with nabilone on cannabis withdrawal and a laboratory model of relapse in cannabis users.
Bedi, G; Comer, SD; Cooper, ZD; Foltin, RW; Haney, M; Herrmann, ES; Ramesh, D; Reed, SC, 2016
)
1.01

Bioavailability

The FDA-approved synthetic analog of THC, nabilone, has higher bioavailability and clearer dose-linearity than dronabinol.

ExcerptReferenceRelevance
" The synthetic THC analogue, nabilone, has better bioavailability than dronabinol."( Subjective, cognitive and cardiovascular dose-effect profile of nabilone and dronabinol in marijuana smokers.
Bedi, G; Cooper, ZD; Haney, M, 2013
)
0.92
" The FDA-approved synthetic analog of THC, nabilone, has higher bioavailability and clearer dose-linearity than dronabinol."( Nabilone decreases marijuana withdrawal and a laboratory measure of marijuana relapse.
Bedi, G; Comer, SD; Cooper, ZD; Foltin, RW; Haney, M; Vosburg, SK, 2013
)
2.1

Dosage Studied

Both studies used nabilone, a synthetic cannabinoid, with a bedtime dosage of 1 mg/day. Nabilone was not potent enough to improve the patients' quality of life over placebo.

ExcerptRelevanceReference
" A dose-response effect was apparent."( Nabilone: a potent antiemetic cannabinol with minimal euphoria.
Dean, J; Dorr, R; Herman, TS; Jones, SE; Leigh, S; Moon, TE; Salmon, SE, 1977
)
1.7
" These results provide a preliminary indication that solid-state NMR spectroscopy is a useful technique for the investigation of drug polymorphs and drugs in their dosage forms."( Analysis of solid-state Carbon-13 NMR spectra of polymorphs (benoxaprofen and nabilone) and pseudopolymorphs (cefazolin).
Byrn, SR; Frye, J; Gray, G; Pfeiffer, RR, 1985
)
0.5
" Nabilone dosage should be reduced to decrease the incidence and degree of adverse reactions while leaving the definite antiemetic activity unchanged."( Crossover comparison of the antiemetic efficacy of nabilone and alizapride in patients with nonseminomatous testicular cancer receiving cisplatin therapy.
Niederle, N; Schmidt, CG; Schütte, J, 1986
)
1.43
" All subjects received two consecutive identical cycles of chemotherapy with the trial antiemetics given in accordance to a body weight-based dosage schedule beginning eight to 12 hours before treatment."( Nabilone versus prochlorperazine for control of cancer chemotherapy-induced emesis in children: a double-blind, crossover trial.
Chan, HS; Correia, JA; MacLeod, SM, 1987
)
1.72
" The study participants chose the dosage of the study drug themselves (between 1 und 4 capsules/day, in the case of nabilone this corresponds to (1/4)-1 mg/day)."( [Benefits of an add-on treatment with the synthetic cannabinomimetic nabilone on patients with chronic pain--a randomized controlled trial].
Hiermann, E; Pinsger, M; Pölz, W; Riederer, F; Schimetta, W; Volc, D, 2006
)
0.78
" We recommend a larger trial with a more prolonged treatment period and an option to slowly increase the dosage further."( A randomized, double-blinded, crossover pilot study assessing the effect of nabilone on spasticity in persons with spinal cord injury.
Casey, A; Ethans, K; Perry, D; Pooyania, S; Szturm, T, 2010
)
0.59
" Reassessment and modulation of dosing and/or medications occurred at 3- and 6-month intervals."( An open-label comparison of nabilone and gabapentin as adjuvant therapy or monotherapy in the management of neuropathic pain in patients with peripheral neuropathy.
Bestard, JA; Toth, CC,
)
0.43
" The CNS effects were assessed at baseline and up to 24 h after dosing using visual analogue mood scales for feeling 'stimulated', 'anxious', 'sedated' and 'down'."( Lack of effect of central nervous system-active doses of nabilone on capsaicin-induced pain and hyperalgesia.
Annas, P; Baxendale, J; Kalliomäki, J; Karlsten, R; Philipp, A; Segerdahl, M, 2012
)
0.62
"At the dosage used, nabilone was not potent enough to improve the patients' quality of life over placebo."( Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial.
Côté, M; Fortin, A; Trudel, M; Wang, C, 2016
)
1.04
" Both studies used nabilone, a synthetic cannabinoid, with a bedtime dosage of 1 mg/day."( Cannabinoids for fibromyalgia.
Fitzcharles, MA; Häuser, W; Klose, P; Phillips, T; Walitt, B, 2016
)
0.76
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (3)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Cannabinoid receptor 1Rattus norvegicus (Norway rat)Ki0.00220.00020.566510.0000AID517909
Cannabinoid receptor 1Homo sapiens (human)Ki0.00360.00010.50779.6000AID1127482; AID502210
Cannabinoid receptor 2 Homo sapiens (human)Ki0.00970.00000.415610.0000AID1127483; AID502212
[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)
Cannabinoid receptor 1Homo sapiens (human)EC50 (µMol)0.00400.00010.12752.2400AID502211
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (39)

Processvia Protein(s)Taxonomy
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)
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)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (4)

Processvia Protein(s)Taxonomy
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)
protein bindingCannabinoid receptor 2 Homo sapiens (human)
cannabinoid receptor activityCannabinoid receptor 2 Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (13)

Processvia Protein(s)Taxonomy
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)
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)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (13)

Assay IDTitleYearJournalArticle
AID517911Selectivity ratio of IC50 for mouse CB2 to IC50 for mouse CB1 receptor2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Novel 1',1'-chain substituted hexahydrocannabinols: 9β-hydroxy-3-(1-hexyl-cyclobut-1-yl)-hexahydrocannabinol (AM2389) a highly potent cannabinoid receptor 1 (CB1) agonist.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID502213Selectivity ratio of Ki for human recombinant CB1 receptor to Ki for human recombinant CB2 receptor2010Bioorganic & medicinal chemistry letters, Sep-01, Volume: 20, Issue:17
Two distinct classes of novel pyrazolinecarboxamides as potent cannabinoid CB1 receptor agonists.
AID502211Agonist activity at human recombinant CB1 receptor expressed in CHO cells assessed as effect on CP-55940 induced PLA2 activation by [3H]arachidonic acid release assay2010Bioorganic & medicinal chemistry letters, Sep-01, Volume: 20, Issue:17
Two distinct classes of novel pyrazolinecarboxamides as potent cannabinoid CB1 receptor agonists.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
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.
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.
AID1901238Hypothermic effect in in female Sprague-Dawley rat model assessed as reduction in body temperature at 0.01 to 10 mg/kg measured as ED50 after 30 to 360 mins2022European journal of medicinal chemistry, Feb-15, Volume: 230Improved cyclobutyl nabilone analogs as potent CB1 receptor agonists.
AID517910Displacement of [3H]CP55940 from mouse spleen CB2 receptor2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Novel 1',1'-chain substituted hexahydrocannabinols: 9β-hydroxy-3-(1-hexyl-cyclobut-1-yl)-hexahydrocannabinol (AM2389) a highly potent cannabinoid receptor 1 (CB1) agonist.
AID502212Displacement of [3H]CP-55940 from human recombinant CB2 receptor expressed in CHO cells2010Bioorganic & medicinal chemistry letters, Sep-01, Volume: 20, Issue:17
Two distinct classes of novel pyrazolinecarboxamides as potent cannabinoid CB1 receptor agonists.
AID502210Displacement of [3H]CP-55940 from human recombinant CB1 receptor expressed in CHO cells2010Bioorganic & medicinal chemistry letters, Sep-01, Volume: 20, Issue:17
Two distinct classes of novel pyrazolinecarboxamides as potent cannabinoid CB1 receptor agonists.
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.
AID517909Displacement of [3H]CP55940 from rat brain CB1 receptor2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Novel 1',1'-chain substituted hexahydrocannabinols: 9β-hydroxy-3-(1-hexyl-cyclobut-1-yl)-hexahydrocannabinol (AM2389) a highly potent cannabinoid receptor 1 (CB1) agonist.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (189)

TimeframeStudies, This Drug (%)All Drugs %
pre-199073 (38.62)18.7374
1990's15 (7.94)18.2507
2000's30 (15.87)29.6817
2010's58 (30.69)24.3611
2020's13 (6.88)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 76.14

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index76.14 (24.57)
Research Supply Index5.61 (2.92)
Research Growth Index4.75 (4.65)
Search Engine Demand Index132.68 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (76.14)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials67 (32.84%)5.53%
Reviews41 (20.10%)6.00%
Case Studies14 (6.86%)4.05%
Observational1 (0.49%)0.25%
Other81 (39.71%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (34)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy [NCT03773796]Phase 322 participants (Actual)Interventional2018-08-06Completed
Nabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal Study [NCT03769896]Phase 248 participants (Actual)Interventional2017-10-03Completed
Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain [NCT03210766]20 participants (Actual)Observational2014-09-01Completed
Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury [NCT04057456]Phase 3140 participants (Anticipated)Interventional2023-03-01Recruiting
The Roles of Endocannabinoids in Insulin Secretion and Action [NCT01517100]Phase 145 participants (Actual)Interventional2012-01-05Completed
Nabilone for Agitation Blinded Intervention Trial [NCT04516057]Phase 3112 participants (Anticipated)Interventional2021-02-01Recruiting
A Randomized, Double-Blind, Placebo Controlled, Parallel Assignment, Efficacy Study of Nabilone in the Treatment of Diabetic Peripheral Neuropathic Pain [NCT01035281]Phase 360 participants (Anticipated)Interventional2008-01-31Recruiting
Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD [NCT03251326]Phase 1/Phase 24 participants (Actual)Interventional2015-10-31Terminated(stopped due to Recruitment difficulties)
Safety and Efficacy of Nabilone in Alzheimer's Disease: a Pilot Study [NCT02351882]Phase 2/Phase 338 participants (Actual)Interventional2015-01-31Completed
A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons [NCT01222468]Phase 212 participants (Actual)Interventional2012-06-30Completed
Nabilone for Cannabis Dependence: A Pilot Study [NCT01347762]Phase 2/Phase 384 participants (Actual)Interventional2010-06-30Completed
Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study [NCT00623376]Phase 20 participants Interventional2007-07-31Completed
Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Patients With Anorexia Associated With Advanced Lung Cancer: Randomized Double Blind Clinical Trial [NCT02802540]Phase 2/Phase 378 participants (Anticipated)Interventional2014-12-31Recruiting
A Randomized Controlled Trial of Cesamet(R) (Nabilone) for the Prevention of Postoperative Nausea and Vomiting in Elective Surgery [NCT02115529]Phase 2331 participants (Actual)Interventional2014-04-30Completed
A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms [NCT05494437]Phase 2234 participants (Actual)Interventional2022-10-27Completed
Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia [NCT05742698]Phase 245 participants (Anticipated)Interventional2023-03-07Active, not recruiting
A Double-Blind Placebo Control Study on the Use of Nabilone for Outpatient Management of Acute Marijuana Withdrawal [NCT01025700]Phase 2/Phase 335 participants (Anticipated)Interventional2009-06-30Completed
A Randomized Double-blinded Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Fibromyalgia [NCT00272207]Phase 240 participants (Actual)Interventional2006-04-30Completed
Impact of Chronic Nabilone Self-administration on Body Weight, Metabolic Markers, Gut Microbiota, and Neural Circuitry in Human Obesity [NCT04801641]Phase 260 participants (Anticipated)Interventional2021-09-17Recruiting
A Randomized Double-blind Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Phantom Limb Pain [NCT00699634]Phase 250 participants (Anticipated)Interventional2009-01-31Completed
A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Multiple Sclerosis [NCT00381264]Phase 423 participants (Anticipated)Interventional2006-09-30Completed
A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting [NCT00418678]Phase 416 participants (Actual)Interventional2006-08-31Terminated(stopped due to Enrollment was too slow)
A Comparative, Single Center, Randomized, Double-blinded, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Nabilone (Cesamet) as Adjunctive Therapy to Gabapentin (Neurontin) in the Management of Neuropathic Pain (NPP) Symptoms in Subjects Wi [NCT00480181]Phase 450 participants (Anticipated)Interventional2007-06-30Completed
Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder [NCT04880278]Phase 1/Phase 260 participants (Anticipated)Interventional2022-03-01Recruiting
A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy [NCT00380913]Phase 423 participants (Anticipated)Interventional2006-09-30Completed
Investigating the Effects of Nabilone on Endocannabinoid Metabolism in the Human Brain [NCT05885685]Phase 430 participants (Anticipated)Interventional2023-06-30Not yet recruiting
Cannabinoid Medication for Adults With Obsessive-Compulsive Disorder (OCD) [NCT02911324]Phase 1/Phase 216 participants (Actual)Interventional2016-09-30Completed
A Multicenter Trial Evaluating the Safety and Efficacy of Cesamet™ for the Symptomatic Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer [NCT00380965]Phase 423 participants (Anticipated)Interventional2006-10-31Completed
Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia [NCT00381199]32 participants (Actual)Interventional2006-04-30Completed
Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients: A Placebo-Controlled, Randomized, Crossover Insomnia Pilot Study [NCT00384410]Phase 216 participants Interventional2005-12-31Recruiting
Nabilone Use for Acute Pain in Inflammatory Bowel Disease Patients With Chronic Opioid Use Undergoing Gastrointestinal Surgery: A Single-centered Randomized Controlled Trial [NCT03422861]80 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Randomized-Controlled Trial With the Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation [NCT04807829]Phase 20 participants (Actual)Interventional2021-04-30Withdrawn(stopped due to The study was stopped due to drug unavailability. The drug is unavailable because production was discontinued in the US.)
Dialysis Symptom Control-Pruritus Outcome Trial: A Randomized Blinded Placebo Controlled Crossover Trial [NCT05180968]Phase 314 participants (Actual)Interventional2022-08-02Completed
Phase I Pre-pilot Open-label Clinical Trial of Nabilone for Severe Behavioural Problems (Aggression) in Adults With Intellectual and Developmental Disabilities [NCT05273320]Phase 130 participants (Anticipated)Interventional2022-03-17Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01347762 (3) [back to overview]Change From Baseline in Cannabis Use at 10 Weeks
NCT01347762 (3) [back to overview]Change From Baseline Cannabis Use at 14 Weeks
NCT01347762 (3) [back to overview]Number of Marijuana Inhales Per Day
NCT02911324 (2) [back to overview]Change in Yale-Brown Obsessive Compulsive Scale
NCT02911324 (2) [back to overview]Feasibility of Recruitment
NCT03769896 (22) [back to overview]Changes in Quality of Life of PD
NCT03769896 (22) [back to overview]Changes of Non-motor Symptoms
NCT03769896 (22) [back to overview]Clinical Global Impression - Global Improvement (CGI-I) Scale
NCT03769896 (22) [back to overview]Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS
NCT03769896 (22) [back to overview]Orthostatic Hypotension in PD Patients Taking Nabilone
NCT03769896 (22) [back to overview]Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.
NCT03769896 (22) [back to overview]Subject Incompliance in PD Patients Taking Nabilone
NCT03769896 (22) [back to overview]Suicidality in PD Patients Taking Nabilone.
NCT03769896 (22) [back to overview]Changes in Different Domains of Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Changes in Motor and Different Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Changes in Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.
NCT03769896 (22) [back to overview]Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.
NCT03769896 (22) [back to overview]Changes in Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Change in Hallucinations in PD Patients Taking Nabilone
NCT03769896 (22) [back to overview]Changes in Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Changes in Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Changes in Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Weight (kg) in PD Patients Taking Nabilone.
NCT03769896 (22) [back to overview]Changes in Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Changes in Non-motor Symptoms of PD
NCT03769896 (22) [back to overview]Changes in Non-motor Symptoms of PD
NCT03773796 (19) [back to overview]AEs in PD Patients Taking Nabilone, Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Cognitive Function (MMSE) in Patients With PD Taking Nabilone
NCT03773796 (19) [back to overview]Changes in Cognitive Function (MoCA) in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Impulsive-compulsive Behaviour in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Quality of Life in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3
NCT03773796 (19) [back to overview]Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Non-motor Symptoms (NMSS) in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale
NCT03773796 (19) [back to overview]Subject Compliance in PD Patients Taking Nabilone.
NCT03773796 (19) [back to overview]Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3
NCT03773796 (19) [back to overview]Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3

Change From Baseline in Cannabis Use at 10 Weeks

Quantitative cannabis urine screens (THC-COOH:Creatinine ratio) (NCT01347762)
Timeframe: baseline and 10 weeks

InterventionRatio (Mean)
Nabilone Titrated 2 mg Daily (Phase 1)268.8
Placebo (Phase 1)286.7
Nabilone Titrated to 4 mg Daily (Phase 2)490.3
Placebo (Phase 2)216.9

[back to top]

Change From Baseline Cannabis Use at 14 Weeks

quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14) (NCT01347762)
Timeframe: baseline and 14 weeks

InterventionRatio (Mean)
Nabilone Titrated 2 mg Daily (Phase 1)524.2
Placebo (Phase 1)326.7
Nabilone Titrated to 4 mg Daily (Phase 2)297.7
Placebo (Phase 2)222

[back to top]

Number of Marijuana Inhales Per Day

Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment. (NCT01347762)
Timeframe: Week 10

InterventionInhales per day (Mean)
Nabilone Titrated 2 mg Daily (Phase 1)33.8
Placebo (Phase 1)22.6
Nabilone Titrated to 4 mg Daily (Phase 2)15.8
Placebo (Phase 2)10.6

[back to top]

Change in Yale-Brown Obsessive Compulsive Scale

"Yale-Brown Obsessive Compulsive Scale (YBOCS) Minimum Value: 0 Maximum Value: 40 Higher scores indicate more severe symptoms~Change in YBOCS is calculated by subtracting the Week 4 score from the baseline score" (NCT02911324)
Timeframe: Baseline (Week 0) and Week 4

,
Interventionscore on a scale (Mean)
Week 4 YBOCS ScoreYBOCS Change
Nabilone24.02.5
Nabilone and EX/RP14.211.2

[back to top]

Feasibility of Recruitment

Number of eligible participants recruited per month over a 1 year period. (NCT02911324)
Timeframe: Through study completion, an average of 1 year.

Interventionparticipants per month (Number)
Flow0.73

[back to top]

Changes in Quality of Life of PD

Parkinson´s Disease Questionnaire - 39 (PDQ-39) Minimum: 0, maximum: 156, higher score values indicate a worse outcome. Values were standardized = PDQ-39 Summary Index (SI, the score of each subdomain was divided by the number of questions of that domain and then multiplied by hundred, the sum score is the sum of the results of all 8 domains) (NCT03769896)
Timeframe: from baseline to week 4 + 2 days

Interventionunits on a scale (Mean)
Treatment Group-0.49
Placebo Group-0.47

[back to top]

Changes of Non-motor Symptoms

Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I minimum points: 0, maximum points: 52, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

Interventionunits on a scale (Mean)
Treatment Group1.00
Placebo Group2.63

[back to top]

Clinical Global Impression - Global Improvement (CGI-I) Scale

Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: Values of the Termination visit (4 weeks + 2 days from baseline)

Interventionunits on a scale (Mean)
Treatment Group4.95
Placebo Group4.42

[back to top]

Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS

Changes in points of the Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) , minimum of 0, maximum of 4 points, higher score values representing a worse outcome (NCT03769896)
Timeframe: from baseline to week 4 + 2 days

Interventionunits on a scale (Mean)
Treatment Group0.26
Placebo Group0.11

[back to top]

Orthostatic Hypotension in PD Patients Taking Nabilone

Changes in points of the Orthostatic hypotension (OH) item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS), minimum of 0, maximum of 4 points, higher score values representing a worse outcome. (NCT03769896)
Timeframe: from baseline to week 4 + 2 days

Interventionunits on a scale (Mean)
Treatment Group0.21
Placebo Group-0.26

[back to top]

Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.

changes in temperature (degree Celsius) (NCT03769896)
Timeframe: from baseline to week 4 + 2 days

Interventiondegree Celsius (Mean)
Treatment Group0.17
Placebo Group0.35

[back to top]

Subject Incompliance in PD Patients Taking Nabilone

subject incompliance as per drug accountability. (NCT03769896)
Timeframe: from baseline to week 4 + 2 days

InterventionParticipants (Count of Participants)
Treatment Group0
Placebo Group0

[back to top]

Suicidality in PD Patients Taking Nabilone.

"Assessment of aggregated data (suicidality present / no suicidality) of the Columbia-Suicide Severity Rating Scale (C-SSRS). The scale consists of questions for suicidality that can be answered with either yes or no. The answer no indicates no wish to be dead, no suicidal ideations, or suicidal attempts.~No minimum or maximum score values can be provided. The values provided represent the number of patients with (new) suicidality." (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

InterventionParticipants (Count of Participants)
Treatment Group0
Placebo Group0

[back to top]

Changes in Different Domains of Non-motor Symptoms of PD

mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4) and different other domains of NMSS and MDS-UPDRS part I Each items scores 0 to 4 points with higher score values indicating a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

,
Interventionunits on a scale (Mean)
MDS-UPDRS 1.3 Depressed MoodMDS-UPDRS 1.4 Anxious MoodMDS-UPDRS 1.7 Nighttime sleep problems
Placebo Group0.160.211.79
Treatment Group0.11-0.160.05

[back to top]

Changes in Motor and Different Non-motor Symptoms of PD

"Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part II: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.~Part III: minimum points: 0, maximum points: 132, higher score values indicate a worse outcome." (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

,
Interventionunits on a scale (Mean)
MDS-UPDRS IIMDS-UPDRS III
Placebo Group0.902.63
Treatment Group0.470.53

[back to top]

Changes in Non-motor Symptoms of PD

Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

,
Interventionunits on a scale (Mean)
Hospital anxiety and depression scale - AnxietyHospital anxiety and depression scale - Depression
Placebo Group0.050.16
Treatment Group0.260.32

[back to top]

Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.

"changes in supine and standing blood pressure measurements (mmHg)~Row titles:~Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the baseline visit~Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit~Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit~Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit" (NCT03769896)
Timeframe: values from baseline and week 4 + 2 days

,
InterventionmmHg (Mean)
Baseline: Change supine - 3 min standing, SBPweek4: Change supine - 3 min standing, SBPBaseline: Change supine - 3 min standing, DBPweek4: Change supine - 3 min standing, DBP
Placebo Group-4.05-2.953.16-0.79
Treatment Group1.47-1.843.794.11

[back to top]

Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.

"Safety and tolerability will be evaluated with reference to the following:~Number of subjects (%) who discontinue the study Number of subjects (%) who discontinue the study due to AE Adverse Events (AE): total number of patients with all adverse events is reported (no reporting threshold)" (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

,
InterventionParticipants (Count of Participants)
Number of subjects who discontinue the studyNumber of subjects who discontinue due to AEsTotal number of patients with Adverse Events
Placebo Group008
Treatment Group006

[back to top]

Changes in Non-motor Symptoms of PD

Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

Interventionunits on a scale (Mean)
Treatment Group0.74
Placebo Group0.00

[back to top]

Change in Hallucinations in PD Patients Taking Nabilone

Number of patients with changes in the points of the Hallucination item (1.2) of the Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS). (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

InterventionParticipants (Count of Participants)
Treatment Group0
Placebo Group0

[back to top]

Changes in Non-motor Symptoms of PD

Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

Interventionunits on a scale (Mean)
Treatment Group-0.74
Placebo Group-0.79

[back to top]

Changes in Non-motor Symptoms of PD

Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

Interventionunits on a scale (Mean)
Treatment Group-4.00
Placebo Group0.00

[back to top]

Changes in Non-motor Symptoms of PD

King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

Interventionunits on a scale (Mean)
Treatment Group1.58
Placebo Group2.84

[back to top]

Weight (kg) in PD Patients Taking Nabilone.

changes in weight (kg) (NCT03769896)
Timeframe: from baseline to week 4 + 2 days

Interventionkg (Mean)
Treatment Group-0.70
Placebo Group-0.52

[back to top]

Changes in Non-motor Symptoms of PD

Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

Interventionscore on a scale (Mean)
Treatment Group4.05
Placebo Group11.00

[back to top]

Changes in Non-motor Symptoms of PD

Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

Interventionunits on a scale (Mean)
Treatment Group-0.68
Placebo Group0.05

[back to top]

Changes in Non-motor Symptoms of PD

Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome. (NCT03769896)
Timeframe: from baseline to 4 weeks + 2 days

Interventionmillimeters on a scale (Mean)
Treatment Group6.58
Placebo Group2.16

[back to top]

AEs in PD Patients Taking Nabilone, Between V 1 and V 3

"Safety and tolerability will be evaluated with reference to the following:~Adverse Events (AE)" (NCT03773796)
Timeframe: 6 months

Interventionadverse events (Number)
Treatment Group39

[back to top]

Changes in Cognitive Function (MMSE) in Patients With PD Taking Nabilone

The change of Mini Mental State Exam (MMSE, minimum 0 points, maximum 30 points, higher score values indicate better outcome) between the Screening Visit of the NMS-Nab Study (before the first intake of nabilone medication) and the termination visit of this study will be assessed as secondary efficacy endpoints. (NCT03773796)
Timeframe: from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion)

Interventionunits on a scale (Mean)
Treatment Group0.42

[back to top]

Changes in Cognitive Function (MoCA) in Patients With PD Taking Nabilone Between V 1 and V 3

The change of Montreal Cognitive Assessment (MoCA, minimum 0 points, maximum 30 points, higher score values indicate better outcome) score values between the Screening Visit of the NMS-Nab Study (before the first intake of nabilone medication) and the termination visit of this study will be assessed as secondary efficacy endpoints. (NCT03773796)
Timeframe: from Screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion)

Interventionunits on a scale (Mean)
Treatment Group-0.11

[back to top]

Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~Fatigue Severity Scale (FSS). Minimum: 9, maximum: 63, higher score values indicate a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group4.26

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Changes in Impulsive-compulsive Behaviour in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group0.11

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Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~Clinical Global Impression - Global Improvement (CGI-I) Minimum: 1, maximum: 7, higher score values indicate a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group-1.16

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Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group-6.84

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Changes in Quality of Life in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~Parkinson´s Disease Questionnaire - 8 (PDQ-8). Minimum: 0, maximum: 42, higher score values indicate a worse outcome.~PDQ-8 was standardized, therefore the score ranges from 0 to 100 (= PDQ-8 Summary Index)." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group-2.96

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Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group0.11

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Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3

"Changes in points of the:~Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Each item has a minimum of 0 and a maximum of 4 points with higher score values representing a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group-0.05

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Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3

"Safety and tolerability will be evaluated with reference to the following:~Number of subjects (%) who discontinue the study due to an AE The reasons for discontinuation will be grouped in discontinuation due to an AE and discontinuation due to other reasons. Both results will be provided separately." (NCT03773796)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Treatment Group1

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Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3

"Safety and tolerability will be evaluated with reference to the following:~Number of subjects (%) who discontinue the study due to other reasons than an AE The reasons for discontinuation will be grouped in discontinuation due to an AE and discontinuation due to other reasons. Both results will be provided separately." (NCT03773796)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Treatment Group1

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Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~Hospital anxiety and depression scale (HADS), HADS-A assesses anxiety, HADS-D depression.~Total scale: minimum: 0, maximum: 42, separate HADS-A/-D score: minimum: 0, maximum: 21.~Higher score values indicate a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
HADS-AHADS-D
Treatment Group-0.161.00

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Changes in Non-motor Symptoms (NMSS) in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group-4.84

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Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3

"Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires:~Total and different parts of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.~Part II: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.~Part III: minimum points: 0, maximum points: 132, higher score values indicate a worse outcome.~Part IV: minimum points: 0, maximum points: 24, higher score values indicate a worse outcome.~Total Score: minimum points: 0, maximum points: 272, higher score values indicate a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
MDS-UPDRS IMDS-UPDRS IIMDS-UPDRS IIIMDS-UPDRS IVMDS-UPDRS Total Score
Treatment Group1.58-0.58-1.89-0.16-1.05

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Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale

"Change in aggregated data of the Columbia-Suicide Severity Rating Scale (C-SSRS).~Different questions for suicidality with the possible answers yes or no. Yes represents a worse outcome. Count of participants with new suicidality is given." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

InterventionParticipants (Count of Participants)
Treatment Group0

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Subject Compliance in PD Patients Taking Nabilone.

subject incompliance as per drug accountability (%) (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

InterventionParticipants (Count of Participants)
Treatment Group0

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Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3

"Changes in points of the:~Orthostatic hypotension item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS)~Each item has a minimum of 0 and a maximum of 4 points with higher score values representing a worse outcome." (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

Interventionunits on a scale (Mean)
Treatment Group-0.16

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Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3

"changes in supine and standing blood pressure measurements (mmHg)~Row titles:~Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at V 1~Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at V 3~Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at V 1~Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at V 3" (NCT03773796)
Timeframe: between V 1 and V 3 (6 months)

InterventionmmHg (Mean)
1. change of SBP from supine to standing position for 3 min at V 12. change of SBP from supine to standing position for 3 min at V 33. change of DBP from supine to standing position for 3 min at V 14. change of DBP from supine to standing position for 3 min at V 3
Treatment Group5.146.050.76-0.42

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