clobazam has been researched along with Benign Infantile Myoclonic Epilepsy in 41 studies
Clobazam: A benzodiazepine derivative that is a long-acting GABA-A RECEPTOR agonist. It is used as an antiepileptic in the treatment of SEIZURES, including seizures associated with LENNOX-GASTAUT SYNDROME. It is also used as an anxiolytic, for the short-term treatment of acute ANXIETY.
clobazam : 7-Chloro-1H-1,5-benzodiazepine-2,4(3H,5H)-dione in which the hydrogen attached to the nitrogen at position 1 is substituted by a methyl group, whilst that attached to the other nitrogen is substituted by a phenyl group. It is used for the short-term management of acute anxiety and as an adjunct in the treatment of epilepsy in association with other antiepileptics.
| Excerpt | Relevance | Reference |
|---|---|---|
| " Following its clinical development, in September 2019 the European Medicines Agency approved its indication for the adjunctive therapy of epileptic seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), combined with clobazam (CLB), in patients of 2 years of age and older." | 9.12 | Cannabidiol for the treatment of Lennox-Gastaut syndrome and Dravet syndrome: experts' recommendations for its use in clinical practice in Spain. ( García-Peñas, JJ; Gil Nagel-Rein, A; Sánchez-Carpintero, R; Villanueva-Haba, V, 2021) |
| "This retrospective chart review study (GWEP20052) evaluated plant-derived highly purified cannabidiol (CBD; Epidyolex®; 100 mg/mL oral solution) use without clobazam as add-on therapy in patients aged ≥2 years with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) enrolled in a European Early Access Program." | 8.31 | Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome. ( Arzimanoglou, A; Auvin, S; Berquin, P; Cross, JH; Desurkar, A; Fuller, D; Nabbout, R; Nortvedt, C; Pulitano, P; Rosati, A; Soto, V; Villanueva, V, 2023) |
| "Stiripentol is an antiepileptic drug (AED) approved by the European Medicines Agency for the treatment of Dravet Syndrome (DS) as adjunct treatment with valproate and clobazam." | 7.81 | Extending the use of stiripentol to other epileptic syndromes: a case of PCDH19-related epilepsy. ( Specchio, N; Trivisano, M; Vigevano, F, 2015) |
| "To survey the treatment situation of Dravet syndrome in Japan and to compare this result with effectiveness of stiripentol (STP) add-on therapy in an open-label multicenter study." | 7.75 | Stiripentol open study in Japanese patients with Dravet syndrome. ( Baba, H; Fukushima, K; Ikeda, S; Inoue, Y; Oguni, H; Ohtani, H; Ohtsuka, Y; Takahashi, Y; Tohyama, J, 2009) |
| " The key outcomes were reduction in seizure frequency, differences in 50% responder rates, adverse events, and interactions with clobazam as co-therapy." | 7.01 | 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) |
| "In addition to reducing convulsive seizure frequency, STP also markedly reduces the number of status epilepticus episodes and associated medical complications which are more common in younger children." | 7.01 | Stiripentol for the treatment of seizures associated with Dravet syndrome in patients 6 months and older and taking clobazam. ( Vasquez, A; Wirrell, EC; Youssef, PE, 2023) |
| " Following its clinical development, in September 2019 the European Medicines Agency approved its indication for the adjunctive therapy of epileptic seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), combined with clobazam (CLB), in patients of 2 years of age and older." | 5.12 | Cannabidiol for the treatment of Lennox-Gastaut syndrome and Dravet syndrome: experts' recommendations for its use in clinical practice in Spain. ( García-Peñas, JJ; Gil Nagel-Rein, A; Sánchez-Carpintero, R; Villanueva-Haba, V, 2021) |
| "To assess the efficacy and safety profile of add-on cannabidiol (CBD) in patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) on clobazam and in the overall population of four randomized, controlled phase 3 trials." | 5.12 | Cannabidiol in conjunction with clobazam: analysis of four randomized controlled trials. ( Bhathal, H; Checketts, D; Chin, RFM; Dunayevich, E; Gunning, B; Mazurkiewicz-Bełdzińska, M; Nortvedt, C, 2021) |
| "The efficacy of cannabidiol (CBD) with and without concomitant clobazam (CLB) was evaluated in stratified analyses of four large randomized controlled trials, two in Lennox-Gastaut syndrome, and two in Dravet syndrome." | 5.05 | Cannabidiol efficacy independent of clobazam: Meta-analysis of four randomized controlled trials. ( Checketts, D; Devinsky, O; Dunayevich, E; Knappertz, V; Morrison, G; Thiele, EA; Wright, S, 2020) |
| "Highly purified cannabidiol (CBD) has demonstrated efficacy with an acceptable safety profile in patients with Lennox-Gastaut syndrome or Dravet syndrome in randomized, double-blind, add-on, controlled phase 3 trials." | 5.05 | 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) |
| "To evaluate the potential impact of concomitant clobazam (CLB) use on the efficacy of cannabidiol (CBD) treatment in patients with Dravet syndrome and Lennox-Gastaut syndrome using meta-analytical techniques." | 5.05 | Cannabidiol efficacy and clobazam status: A systematic review and meta-analysis. ( Brigo, F; Del Giovane, C; Lattanzi, S; Nardone, R; Silvestrini, M; Striano, P; Trinka, E; Zaccara, G, 2020) |
| "Four pivotal randomized placebo-controlled trials have demonstrated that adjunctive therapy with cannabidiol (CBD) improves seizure control in patients with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS)." | 5.05 | Does cannabidiol have antiseizure activity independent of its interactions with clobazam? An appraisal of the evidence from randomized controlled trials. ( Bialer, M; Perucca, E, 2020) |
| "This retrospective chart review study (GWEP20052) evaluated plant-derived highly purified cannabidiol (CBD; Epidyolex®; 100 mg/mL oral solution) use without clobazam as add-on therapy in patients aged ≥2 years with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) enrolled in a European Early Access Program." | 4.31 | Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome. ( Arzimanoglou, A; Auvin, S; Berquin, P; Cross, JH; Desurkar, A; Fuller, D; Nabbout, R; Nortvedt, C; Pulitano, P; Rosati, A; Soto, V; Villanueva, V, 2023) |
| "Clobazam (CLB) is an effective anticonvulsant used as an adjunctive treatment for several seizures and epilepsy syndromes." | 4.12 | CLB add-on treatment in patients with epileptic encephalopathy: a single center experience with long-term follow-up. ( Öztürk, G; Türkdoğan, D, 2022) |
| "Pharmacokinetic data were combined from 3 CLB trials (OV-1012, OV-1017, and study 301) and a simulated study (study 401) for a total of 1306 CLB and 1305 N-desmethyl clobazam (N-CLB) samples from 193 Lennox-Gastaut syndrome patients and healthy subjects aged 6 months to 45 years." | 3.91 | Pharmacometrics of clobazam in pediatrics: Prediction of effective clobazam doses for Dravet syndrome. ( Chu, HM; Ette, EI; Tolbert, D, 2019) |
| "Stiripentol is an antiepileptic drug (AED) approved by the European Medicines Agency for the treatment of Dravet Syndrome (DS) as adjunct treatment with valproate and clobazam." | 3.81 | Extending the use of stiripentol to other epileptic syndromes: a case of PCDH19-related epilepsy. ( Specchio, N; Trivisano, M; Vigevano, F, 2015) |
| "Stiripentol is an effective and well-tolerated therapy that markedly reduced frequency of prolonged seizures in Dravet syndrome." | 3.79 | Stiripentol in Dravet syndrome: results of a retrospective U.S. study. ( Chancharme, L; Chugani, H; de Menezes, MS; Devinsky, O; Franz, DN; Hamiwka, L; Hernandez, A; Laux, L; Le Guern, ME; Mikati, MA; Morse, RP; Saneto, RP; Sullivan, J; Valencia, I; Wirrell, EC, 2013) |
| "To survey the treatment situation of Dravet syndrome in Japan and to compare this result with effectiveness of stiripentol (STP) add-on therapy in an open-label multicenter study." | 3.75 | Stiripentol open study in Japanese patients with Dravet syndrome. ( Baba, H; Fukushima, K; Ikeda, S; Inoue, Y; Oguni, H; Ohtani, H; Ohtsuka, Y; Takahashi, Y; Tohyama, J, 2009) |
| "Clobazam has been used successfully in adults and children with partial epilepsy." | 3.73 | Clobazam as add-on therapy in children with epileptic encephalopathy. ( Guerreiro, CA; Guerreiro, MM; Montenegro, MA; Silva, RC, 2006) |
| " The key outcomes were reduction in seizure frequency, differences in 50% responder rates, adverse events, and interactions with clobazam as co-therapy." | 3.01 | 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) |
| "In addition to reducing convulsive seizure frequency, STP also markedly reduces the number of status epilepticus episodes and associated medical complications which are more common in younger children." | 3.01 | Stiripentol for the treatment of seizures associated with Dravet syndrome in patients 6 months and older and taking clobazam. ( Vasquez, A; Wirrell, EC; Youssef, PE, 2023) |
| "Patients with Dravet syndrome having ≥4 clonic/tonic-clonic seizures per 30 days while on clobazam and valproate (with or without bromide) received add-on stiripentol for 16 weeks." | 2.80 | Long-term safety and efficacy of stiripentol for the treatment of Dravet syndrome: A multicenter, open-label study in Japan. ( Inoue, Y; Ohtsuka, Y, 2015) |
| " They could be so severe in patients over 12 years of age that the stiripentol dosage could not be increased to 50 mg kg-1 j-1." | 2.70 | [Long-term efficacy and tolerance of stiripentaol in severe myoclonic epilepsy of infancy (Dravet's syndrome)]. ( Chiron, C; Dellatolas, G; Dulac, O; Pons, G; Rey, E; Thanh, TN; Vincent, J, 2002) |
| "The former consists mainly of severe myoclonic epilepsy in infancy (SMEN), in which patients exhibit seizures from the middle of the first year of life with repeated episodes of status epilepticus, and migrating partial epilepsy in infancy, in which, from the first trimester of life, partial seizures affect various areas of the cortex randomly and in a subcontinuous fashion." | 2.41 | Epileptic encephalopathy. ( Dulac, O, 2001) |
| "With a growing treatment landscape for Dravet syndrome, there can be practical challenges for clinicians, particularly with issues associated with polypharmacy." | 1.72 | A Practical Guide to the Treatment of Dravet Syndrome with Anti-Seizure Medication. ( Schubert-Bast, S; Strzelczyk, A, 2022) |
| " Pharmacokinetic variability of the total number of measurements of valproate (n = 417), clobazam and N-desmethylclobazam (n = 328), and levetiracetam (n = 238) was determined." | 1.56 | Pharmacokinetic Variability During Long-Term Therapeutic Drug Monitoring of Valproate, Clobazam, and Levetiracetam in Patients With Dravet Syndrome. ( Bjørnvold, M; Burns, ML; Heger, K; Johannessen Landmark, C; Johannessen, SI; Lund, C; Sætre, E, 2020) |
| " However, the intrinsic anticonvulsant activity of CBD has been questioned due to a pharmacokinetic interaction between CBD and a first-line medication, clobazam." | 1.51 | 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) |
| "Dravet syndrome is a catastrophic form of pediatric treatment-resistant epilepsy with few effective treatment options." | 1.48 | Economic Evaluation of Stiripentol for Dravet Syndrome: A Cost-Utility Analysis. ( Clifford, T; Coyle, D; Elliott, J; McCoy, B; Wells, GA, 2018) |
| "Twenty-eight patients with Dravet syndrome (age range, 1-35 years) undergoing combination therapy with VPA and STP were included in this study." | 1.46 | Add-on stiripentol elevates serum valproate levels in patients with or without concomitant topiramate therapy. ( Fukuda, M; Imai, K; Inoue, Y; Jogamoto, T; Ohtsuka, Y; Suzuki, Y; Takahashi, Y; Yamamoto, Y, 2017) |
| "This is the first simultaneous pharmacokinetic model for clobazam and N-CLB in epileptic children." | 1.42 | Pharmacokinetics of clobazam and N-desmethylclobazam in children with dravet syndrome receiving concomitant stiripentol and valproic Acid. ( Chhun, S; Chiron, C; Dulac, O; Jullien, V; Pons, G; Rey, E; Tod, M, 2015) |
| "In addition, the effect on seizure count was compared with that of various AED regimen and the vagus nerve stimulation (VNS)." | 1.42 | Efficacy and tolerability of the ketogenic diet in Dravet syndrome - Comparison with various standard antiepileptic drug regimen. ( Benninger, F; Dressler, A; Feucht, M; Grassl, R; Gröppel, G; Mühlebner, A; Reiter-Fink, E; Reithofer, E; Trimmel-Schwahofer, P, 2015) |
| "Dravet syndrome is a rare form of epilepsy largely refractory to current antiepileptic medications." | 1.42 | The European patient with Dravet syndrome: results from a parent-reported survey on antiepileptic drug use in the European population with Dravet syndrome. ( Aras, LM; Isla, J; Mingorance-Le Meur, A, 2015) |
| "Absence seizures associated with myoclonic phenomena have been associated with 4 seizure types." | 1.40 | Neck myoclonia with absence seizures in an Indian girl. ( Aneja, S; Jain, P; Sharma, S, 2014) |
| "Three patients aged 16, 19, and 65 years with a 13- to 36-year history of partial epilepsy were receiving a therapeutic dosage of carbamazepine or phenobarbital plus either clobazam (CLB) or valproate (VPA)." | 1.30 | Negative myoclonic status due to antiepileptic drug tapering: report of three cases. ( Aguglia, U; Gambardella, A; Oliveri, RL; Quattrone, A; Russo, C; Zappia, M, 1997) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 1 (2.44) | 18.2507 |
| 2000's | 5 (12.20) | 29.6817 |
| 2010's | 18 (43.90) | 24.3611 |
| 2020's | 17 (41.46) | 2.80 |
| Authors | Studies |
|---|---|
| García-Peñas, JJ | 1 |
| Gil Nagel-Rein, A | 2 |
| Sánchez-Carpintero, R | 1 |
| Villanueva-Haba, V | 1 |
| Strzelczyk, A | 3 |
| Schubert-Bast, S | 3 |
| Talwar, A | 1 |
| Estes, E | 1 |
| Aparasu, R | 1 |
| Reddy, DS | 1 |
| Vasquez, A | 1 |
| Wirrell, EC | 2 |
| Youssef, PE | 1 |
| Nabbout, R | 2 |
| Arzimanoglou, A | 1 |
| Auvin, S | 1 |
| Berquin, P | 1 |
| Desurkar, A | 1 |
| Fuller, D | 1 |
| Nortvedt, C | 2 |
| Pulitano, P | 1 |
| Rosati, A | 1 |
| Soto, V | 1 |
| Villanueva, V | 2 |
| Cross, JH | 1 |
| Tolbert, D | 1 |
| Chu, HM | 1 |
| Ette, EI | 1 |
| Anderson, LL | 2 |
| Absalom, NL | 1 |
| Abelev, SV | 1 |
| Low, IK | 1 |
| Doohan, PT | 1 |
| Martin, LJ | 1 |
| Chebib, M | 1 |
| McGregor, IS | 1 |
| Arnold, JC | 1 |
| Specchio, N | 2 |
| Pietrafusa, N | 1 |
| Ferretti, A | 1 |
| Trivisano, M | 2 |
| Vigevano, F | 2 |
| Lattanzi, S | 1 |
| Trinka, E | 1 |
| Striano, P | 1 |
| Zaccara, G | 1 |
| Del Giovane, C | 1 |
| Nardone, R | 1 |
| Silvestrini, M | 1 |
| Brigo, F | 1 |
| Bialer, M | 1 |
| Perucca, E | 1 |
| Johannessen Landmark, C | 1 |
| Heger, K | 1 |
| Lund, C | 1 |
| Burns, ML | 1 |
| Bjørnvold, M | 1 |
| Sætre, E | 1 |
| Johannessen, SI | 1 |
| Devinsky, O | 3 |
| Thiele, EA | 2 |
| Wright, S | 1 |
| Checketts, D | 2 |
| Morrison, G | 3 |
| Dunayevich, E | 2 |
| Knappertz, V | 1 |
| Patsalos, PN | 1 |
| Szaflarski, JP | 1 |
| Gidal, B | 1 |
| VanLandingham, K | 1 |
| Critchley, D | 1 |
| Gunning, B | 1 |
| Mazurkiewicz-Bełdzińska, M | 1 |
| Chin, RFM | 1 |
| Bhathal, H | 1 |
| Türkdoğan, D | 1 |
| Öztürk, G | 1 |
| Carreño-Martínez, M | 1 |
| López-González, FJ | 1 |
| Silvennoinen, K | 1 |
| Ritter, LM | 1 |
| Nashef, L | 1 |
| Hudgell, K | 1 |
| Balestrini, S | 1 |
| Sisodiya, SM | 1 |
| Sidhu, MK | 1 |
| Patel, AD | 1 |
| Wong, MH | 1 |
| Appleton, R | 1 |
| Harden, CL | 1 |
| Greenwood, S | 1 |
| Sommerville, K | 1 |
| Elliott, J | 1 |
| McCoy, B | 1 |
| Clifford, T | 1 |
| Wells, GA | 1 |
| Coyle, D | 1 |
| Manyas, H | 1 |
| Paketci, C | 1 |
| Okur, D | 1 |
| Bayram, E | 1 |
| Hiz, S | 1 |
| Yis, U | 1 |
| Wolff, M | 1 |
| Wiemer-Kruel, A | 1 |
| von Spiczak, S | 1 |
| Trollmann, R | 1 |
| Reif, PS | 1 |
| Pritchard, C | 1 |
| Polster, T | 1 |
| Neubauer, BA | 1 |
| Mayer, T | 1 |
| Macdonald, D | 1 |
| Kurlemann, G | 1 |
| Kluger, G | 1 |
| Klein, KM | 1 |
| Kieslich, M | 1 |
| Kay, L | 1 |
| Kalski, M | 1 |
| Irwin, J | 1 |
| Herting, A | 1 |
| Carroll, J | 1 |
| Bettendorf, U | 1 |
| Bast, T | 1 |
| Rosenow, F | 2 |
| Yamamoto, Y | 2 |
| Takahashi, Y | 4 |
| Ikeda, H | 1 |
| Imai, K | 2 |
| Kagawa, Y | 1 |
| Inoue, Y | 6 |
| Laux, L | 1 |
| Franz, DN | 1 |
| Sullivan, J | 1 |
| Saneto, RP | 1 |
| Morse, RP | 1 |
| Chugani, H | 1 |
| Hernandez, A | 1 |
| Hamiwka, L | 1 |
| Mikati, MA | 1 |
| Valencia, I | 1 |
| Le Guern, ME | 1 |
| Chancharme, L | 1 |
| de Menezes, MS | 1 |
| Jain, P | 1 |
| Sharma, S | 1 |
| Aneja, S | 1 |
| Ohtsuka, Y | 4 |
| Reese, JP | 1 |
| Stephani, U | 1 |
| Boor, R | 1 |
| Jullien, V | 1 |
| Chhun, S | 1 |
| Rey, E | 3 |
| Dulac, O | 5 |
| Tod, M | 1 |
| Chiron, C | 4 |
| Pons, G | 3 |
| Dressler, A | 1 |
| Trimmel-Schwahofer, P | 1 |
| Reithofer, E | 1 |
| Mühlebner, A | 1 |
| Gröppel, G | 1 |
| Reiter-Fink, E | 1 |
| Benninger, F | 1 |
| Grassl, R | 1 |
| Feucht, M | 1 |
| Aras, LM | 1 |
| Isla, J | 1 |
| Mingorance-Le Meur, A | 1 |
| De Liso, P | 1 |
| Chemaly, N | 1 |
| Laschet, J | 1 |
| Barnerias, C | 1 |
| Hully, M | 1 |
| Leunen, D | 1 |
| Desguerre, I | 1 |
| Hawkins, NA | 1 |
| Zachwieja, NJ | 1 |
| Miller, AR | 1 |
| Kearney, JA | 1 |
| Jogamoto, T | 1 |
| Fukuda, M | 1 |
| Suzuki, Y | 1 |
| Oguni, H | 1 |
| Tohyama, J | 1 |
| Baba, H | 1 |
| Fukushima, K | 1 |
| Ohtani, H | 2 |
| Ikeda, S | 1 |
| Cao, D | 1 |
| Ogiwara, I | 1 |
| Ohtani, S | 1 |
| Yamakawa, K | 1 |
| Thanh, TN | 1 |
| Dellatolas, G | 1 |
| Vincent, J | 2 |
| Silva, RC | 1 |
| Montenegro, MA | 1 |
| Guerreiro, CA | 1 |
| Guerreiro, MM | 1 |
| Gambardella, A | 1 |
| Aguglia, U | 1 |
| Oliveri, RL | 1 |
| Russo, C | 1 |
| Zappia, M | 1 |
| Quattrone, A | 1 |
| Marchand, MC | 1 |
| Tran, A | 1 |
| d'Athis, P | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| CBD Cannabis Extract: Pharmacokinetic Studies[NCT04280289] | Early Phase 1 | 10 participants (Anticipated) | Interventional | 2020-12-01 | Not yet recruiting | ||
| 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 2 | 34 participants (Actual) | Interventional | 2014-10-22 | Completed | ||
| Verapamil as Adjunctive Seizure Therapy for Children and Young Adults With Dravet Syndrome[NCT01607073] | Phase 2 | 2 participants (Actual) | Interventional | 2012-04-30 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"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)
| Intervention | Participants (Count of Participants) |
|---|---|
| GWP42003-P 5 mg/kg/Day Dose | 2 |
| GWP42003-P 10 mg/kg/Day Dose | 1 |
| GWP42003-P 20 mg/kg/Day Dose | 0 |
| Placebo | 1 |
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
| Intervention | hours * nanograms/mL (Geometric Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Day 1 CBD | Day 22 CBD | Day 1 6-OH-CBD | Day 22 6-OH-CBD | Day 1 7-OH-CBD | Day 22 7-OH-CBD | Day 1 7-COOH-CBD | Day 22 7-COOH-CBD | |
| GWP42003-P 10 mg/kg/Day Dose | 66.35 | 721.8 | 2.79 | 26.3 | 18.4 | 244 | 125 | 9220 |
| GWP42003-P 20 mg/kg/Day Dose | 73.69 | 962.6 | 5.16 | 58.6 | 30.2 | 508 | 195 | 15500 |
| GWP42003-P 5 mg/kg/Day Dose | 70.61 | 240.8 | 3.27 | 9.33 | 21.9 | 131 | 297 | 4190 |
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
| Intervention | percent change (Number) | |
|---|---|---|
| % change in CLB | % change in N-CLB | |
| GWP42003-P 10 mg/kg/Day Dose | 18.0 | 170.7 |
| GWP42003-P 20 mg/kg/Day Dose | 29.6 | 228.9 |
| GWP42003-P 5 mg/kg/Day Dose | -1.2 | 258.7 |
| Placebo | 15.1 | -5.6 |
The secondary outcome measure is the change in number of absence seizures from Week 8 (Baseline) to Week 12 (NCT01607073)
Timeframe: Week 8 to Week 12
| Intervention | Abscence seizures (Number) |
|---|---|
| Week 8 Baseline | 165 |
| Week 12 Verapamil 4mg/kg/Day | 101 |
The primary study endpoint is the change in number of seizures from baseline. Since we only had one participant finish the study, the endpoint was changed to Week 12 visit. Participants were on verapamil for 4 weeks at Week 12. (NCT01607073)
Timeframe: Week 8 (baseline) to Week 12
| Intervention | General tonic-clonic seizures (Number) |
|---|---|
| Week 8 Baseline | 39 |
| Week 12 Verapamil 4mg/kg/Day | 14 |
The secondary outcome is the change in number of myoclonic seizures between baseline Week 8 visit and Week 12 visit. (NCT01607073)
Timeframe: Week 8 (baseline) to Week 12
| Intervention | Myoclonic seizures (Number) |
|---|---|
| Week 8 Baseline | 116 |
| Week 12 Verapamil 4mg/kg/Day | 175 |
11 reviews available for clobazam and Benign Infantile Myoclonic Epilepsy
| Article | Year |
|---|---|
Cannabidiol for the treatment of Lennox-Gastaut syndrome and Dravet syndrome: experts' recommendations for its use in clinical practice in Spain.
Topics: Anticonvulsants; Cannabidiol; Clobazam; Clonazepam; Diazepam; Dioxolanes; Drug Administration Schedu | 2021 |
Clinical efficacy and safety of cannabidiol for pediatric refractory epilepsy indications: A systematic review and meta-analysis.
Topics: Adult; Anticonvulsants; Cannabidiol; Child; Clobazam; Drug Resistant Epilepsy; Epilepsies, Myoclonic | 2023 |
Stiripentol for the treatment of seizures associated with Dravet syndrome in patients 6 months and older and taking clobazam.
Topics: Anticonvulsants; Child; Child, Preschool; Clobazam; Epilepsies, Myoclonic; Humans; Observational Stu | 2023 |
Cannabidiol efficacy and clobazam status: A systematic review and meta-analysis.
Topics: Anticonvulsants; Cannabidiol; Clobazam; Drug Therapy, Combination; Epilepsies, Myoclonic; Humans; Le | 2020 |
Does cannabidiol have antiseizure activity independent of its interactions with clobazam? An appraisal of the evidence from randomized controlled trials.
Topics: Anticonvulsants; Cannabidiol; Clobazam; Drug Interactions; Drug Therapy, Combination; Epilepsies, My | 2020 |
Cannabidiol efficacy independent of clobazam: Meta-analysis of four randomized controlled trials.
Topics: Anticonvulsants; Cannabidiol; Clobazam; Drug Therapy, Combination; Epilepsies, Myoclonic; Humans; Le | 2020 |
Clinical implications of trials investigating drug-drug interactions between cannabidiol and enzyme inducers or inhibitors or common antiseizure drugs.
Topics: Anticonvulsants; Cannabidiol; Clinical Trials as Topic; Clobazam; Cytochrome P-450 CYP2C19; Cytochro | 2020 |
Cannabidiol in conjunction with clobazam: analysis of four randomized controlled trials.
Topics: Adult; Anticonvulsants; Cannabidiol; Clobazam; Epilepsies, Myoclonic; Female; Humans; Lennox Gastaut | 2021 |
New therapeutic approach in Dravet syndrome and Lennox-Gastaut syndrome with cannabidiol.
Topics: Administration, Oral; Adolescent; Algorithms; Anticonvulsants; Cannabidiol; Child; Child, Preschool; | 2021 |
Seizure management and prescription patterns of anticonvulsants in Dravet syndrome: A multicenter cohort study from Germany and review of literature.
Topics: Anticonvulsants; Clobazam; Cohort Studies; Drug Prescriptions; Drug Therapy, Combination; Epilepsies | 2019 |
Epileptic encephalopathy.
Topics: Adolescent; Age Factors; Anti-Anxiety Agents; Anticonvulsants; Benzodiazepines; Brain Diseases; Chil | 2001 |
5 trials available for clobazam and Benign Infantile Myoclonic Epilepsy
| Article | Year |
|---|---|
Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome.
Topics: Anticonvulsants; Benzodiazepines; Cannabidiol; Child; Child, Preschool; Clobazam; Dose-Response Rela | 2018 |
Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome.
Topics: Anticonvulsants; Benzodiazepines; Cannabidiol; Child; Child, Preschool; Clobazam; Dose-Response Rela | 2018 |
Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome.
Topics: Anticonvulsants; Benzodiazepines; Cannabidiol; Child; Child, Preschool; Clobazam; Dose-Response Rela | 2018 |
Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome.
Topics: Anticonvulsants; Benzodiazepines; Cannabidiol; Child; Child, Preschool; Clobazam; Dose-Response Rela | 2018 |
Effectiveness of add-on stiripentol to clobazam and valproate in Japanese patients with Dravet syndrome: additional supportive evidence.
Topics: Adolescent; Adult; Anticonvulsants; Asian People; Benzodiazepines; Child; Child, Preschool; Clobazam | 2014 |
Long-term safety and efficacy of stiripentol for the treatment of Dravet syndrome: A multicenter, open-label study in Japan.
Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Dioxolanes; | 2015 |
[Long-term efficacy and tolerance of stiripentaol in severe myoclonic epilepsy of infancy (Dravet's syndrome)].
Topics: Anti-Anxiety Agents; Anticonvulsants; Benzodiazepines; Child, Preschool; Clobazam; Dioxolanes; Epile | 2002 |
Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial. STICLO study group.
Topics: Anti-Anxiety Agents; Anticonvulsants; Benzodiazepines; Child, Preschool; Clobazam; Dioxolanes; Doubl | 2000 |
25 other studies available for clobazam and Benign Infantile Myoclonic Epilepsy
| Article | Year |
|---|---|
A Practical Guide to the Treatment of Dravet Syndrome with Anti-Seizure Medication.
Topics: Adult; Anticonvulsants; Cannabidiol; Child; Clobazam; Drug Therapy, Combination; Epilepsies, Myoclon | 2022 |
Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome.
Topics: Adolescent; Anticonvulsants; Cannabidiol; Clobazam; Epilepsies, Myoclonic; Humans; Lennox Gastaut Sy | 2023 |
Pharmacometrics of clobazam in pediatrics: Prediction of effective clobazam doses for Dravet syndrome.
Topics: Adolescent; Adult; Anticonvulsants; Child; Child, Preschool; Clobazam; Dose-Response Relationship, D | 2019 |
Coadministered cannabidiol and clobazam: Preclinical evidence for both pharmacodynamic and pharmacokinetic interactions.
Topics: Animals; Anticonvulsants; Cannabidiol; Clobazam; Dose-Response Relationship, Drug; Drug Evaluation, | 2019 |
Successful use of fenfluramine in nonconvulsive status epilepticus of Dravet syndrome.
Topics: Anticonvulsants; Child; Clobazam; Drug Therapy, Combination; Epilepsies, Myoclonic; Fenfluramine; Hu | 2020 |
Pharmacokinetic Variability During Long-Term Therapeutic Drug Monitoring of Valproate, Clobazam, and Levetiracetam in Patients With Dravet Syndrome.
Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Dioxolanes; | 2020 |
CLB add-on treatment in patients with epileptic encephalopathy: a single center experience with long-term follow-up.
Topics: Adolescent; Anticonvulsants; Child; Child, Preschool; Clobazam; Drug Therapy, Combination; Epilepsie | 2022 |
Two-center experience of cannabidiol use in adults with Dravet syndrome.
Topics: Adult; Anticonvulsants; Cannabidiol; Clobazam; Epilepsies, Myoclonic; Female; Humans; Middle Aged; Q | 2021 |
Economic Evaluation of Stiripentol for Dravet Syndrome: A Cost-Utility Analysis.
Topics: Anticonvulsants; Canada; Child; Clobazam; Cost-Benefit Analysis; Dioxolanes; Drug Therapy, Combinati | 2018 |
A Drug Reaction With Eosinophilia and Systemic Symptoms Syndrome Associated With Clobazam.
Topics: Anticonvulsants; Child, Preschool; Clobazam; Drug Hypersensitivity Syndrome; Eosinophilia; Epilepsie | 2020 |
Impact of CYP2C19 Phenotypes on Clinical Efficacy of Stiripentol in Japanese Patients With Dravet Syndrome.
Topics: Adolescent; Adult; Anticonvulsants; Asian People; Child; Child, Preschool; Clobazam; Cytochrome P-45 | 2020 |
Stiripentol in Dravet syndrome: results of a retrospective U.S. study.
Topics: Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Dioxolanes; Drug Therapy, Combi | 2013 |
Neck myoclonia with absence seizures in an Indian girl.
Topics: Anticonvulsants; Benzodiazepines; Brain; Child; Clobazam; Electroencephalography; Epilepsies, Myoclo | 2014 |
Evaluation of health-care utilization in patients with Dravet syndrome and on adjunctive treatment with stiripentol and clobazam.
Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Dioxolanes; | 2014 |
Pharmacokinetics of clobazam and N-desmethylclobazam in children with dravet syndrome receiving concomitant stiripentol and valproic Acid.
Topics: Anticonvulsants; Benzodiazepines; Body Weight; Child; Child, Preschool; Clobazam; Dioxolanes; Drug I | 2015 |
Extending the use of stiripentol to other epileptic syndromes: a case of PCDH19-related epilepsy.
Topics: Age of Onset; Anticonvulsants; Autistic Disorder; Benzodiazepines; Cadherins; Child; Clobazam; Cogni | 2015 |
Efficacy and tolerability of the ketogenic diet in Dravet syndrome - Comparison with various standard antiepileptic drug regimen.
Topics: Adolescent; Anticonvulsants; Benzodiazepines; Bromides; Child; Child, Preschool; Clobazam; Diet, Ket | 2015 |
The European patient with Dravet syndrome: results from a parent-reported survey on antiepileptic drug use in the European population with Dravet syndrome.
Topics: Adolescent; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Dioxolanes; Epileps | 2015 |
Patients with dravet syndrome in the era of stiripentol: A French cohort cross-sectional study.
Topics: Adolescent; Age Factors; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Cross- | 2016 |
Fine Mapping of a Dravet Syndrome Modifier Locus on Mouse Chromosome 5 and Candidate Gene Analysis by RNA-Seq.
Topics: Animals; Benzodiazepines; Chromosome Mapping; Chromosomes; Clobazam; Disease Models, Animal; Epileps | 2016 |
Add-on stiripentol elevates serum valproate levels in patients with or without concomitant topiramate therapy.
Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Cytochrome P | 2017 |
Stiripentol open study in Japanese patients with Dravet syndrome.
Topics: Adolescent; Adult; Anticonvulsants; Aryl Hydrocarbon Hydroxylases; Benzodiazepines; Child; Child, Pr | 2009 |
Efficacy of stiripentol in hyperthermia-induced seizures in a mouse model of Dravet syndrome.
Topics: Age Factors; Animals; Anticonvulsants; Benzodiazepines; Clobazam; Dioxolanes; Disease Models, Animal | 2012 |
Clobazam as add-on therapy in children with epileptic encephalopathy.
Topics: Adolescent; Anticonvulsants; Benzodiazepines; Brain; Child; Child, Preschool; Clobazam; Dose-Respons | 2006 |
Negative myoclonic status due to antiepileptic drug tapering: report of three cases.
Topics: Adolescent; Aged; Anti-Anxiety Agents; Anticonvulsants; Benzodiazepines; Benzodiazepinones; Cerebral | 1997 |