clobazam has been researched along with Deficiency, Mental in 17 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 |
---|---|---|
"To determine long-term safety and efficacy of adjunctive clobazam for patients with Lennox-Gastaut syndrome (LGS)." | 9.19 | Stable dosages of clobazam for Lennox-Gastaut syndrome are associated with sustained drop-seizure and total-seizure improvements over 3 years. ( Conry, JA; Drummond, R; Isojarvi, J; Kernitsky, L; Lee, D; Mitchell, WG; Ng, YT; Paolicchi, JM; Veidemanis, R, 2014) |
"In an ongoing open-label extension (OV-1004), patients with Lennox-Gastaut syndrome who had completed 1 of 2 randomized controlled trials (OV-1002 [Phase II] or OV-1012 [Phase III]) are receiving clobazam at dosages ≤2." | 9.16 | Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study. ( Conry, J; Drummond, R; Isojarvi, J; Kernitsky, L; Lee, D; Mitchell, W; Ng, YT; Owen, R; Paolicchi, J, 2012) |
"To evaluate efficacy and safety of clobazam, a 1,5-benzodiazepine, as adjunctive therapy for Lennox-Gastaut syndrome (LGS)." | 9.15 | Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. ( Conry, JA; Drummond, R; Ng, YT; Stolle, J; Weinberg, MA, 2011) |
"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) |
"Clobazam is a promising antiepileptic medication, given its effectiveness and relatively low rates of adverse effects." | 6.48 | Clobazam for patients with Lennox-Gastaut syndrome and epilepsy. ( Ng, YT; Seif-Eddeine, H, 2012) |
"To assess withdrawal-related adverse event (AE) rates following abrupt clobazam discontinuation in Phase I trials and gradual clobazam tapering (2-3 weeks) following discontinuation from III trials met the criteria for potential/III trials, we evaluated AE data from four multiple-dosage Phase I trials (duration: 8-34 days)." | 5.40 | Withdrawal-related adverse events from clinical trials of clobazam in Lennox-Gastaut syndrome. ( Bekersky, I; Harris, SI; Isojarvi, J; Lee, D; Tolbert, D, 2014) |
"To determine long-term safety and efficacy of adjunctive clobazam for patients with Lennox-Gastaut syndrome (LGS)." | 5.19 | Stable dosages of clobazam for Lennox-Gastaut syndrome are associated with sustained drop-seizure and total-seizure improvements over 3 years. ( Conry, JA; Drummond, R; Isojarvi, J; Kernitsky, L; Lee, D; Mitchell, WG; Ng, YT; Paolicchi, JM; Veidemanis, R, 2014) |
"In an ongoing open-label extension (OV-1004), patients with Lennox-Gastaut syndrome who had completed 1 of 2 randomized controlled trials (OV-1002 [Phase II] or OV-1012 [Phase III]) are receiving clobazam at dosages ≤2." | 5.16 | Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study. ( Conry, J; Drummond, R; Isojarvi, J; Kernitsky, L; Lee, D; Mitchell, W; Ng, YT; Owen, R; Paolicchi, J, 2012) |
"To evaluate efficacy and safety of clobazam, a 1,5-benzodiazepine, as adjunctive therapy for Lennox-Gastaut syndrome (LGS)." | 5.15 | Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. ( Conry, JA; Drummond, R; Ng, YT; Stolle, J; Weinberg, MA, 2011) |
"Clobazam was recently approved for Lennox-Gastaut syndrome in the United States." | 4.89 | Clobazam therapeutic drug monitoring: a comprehensive review of the literature with proposals to improve future studies. ( de Leon, J; Diaz, FJ; Spina, E, 2013) |
"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) |
"Clobazam is a promising antiepileptic medication, given its effectiveness and relatively low rates of adverse effects." | 2.48 | Clobazam for patients with Lennox-Gastaut syndrome and epilepsy. ( Ng, YT; Seif-Eddeine, H, 2012) |
"To assess withdrawal-related adverse event (AE) rates following abrupt clobazam discontinuation in Phase I trials and gradual clobazam tapering (2-3 weeks) following discontinuation from III trials met the criteria for potential/III trials, we evaluated AE data from four multiple-dosage Phase I trials (duration: 8-34 days)." | 1.40 | Withdrawal-related adverse events from clinical trials of clobazam in Lennox-Gastaut syndrome. ( Bekersky, I; Harris, SI; Isojarvi, J; Lee, D; Tolbert, D, 2014) |
"Clobazam is a new benzodiazepine recently introduced in Canada on an experimental basis." | 1.27 | Clobazam for refractory childhood seizure disorders--a valuable supplementary drug. ( Camfield, C; Camfield, P; Dooley, J; Munn, R, 1988) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 2 (11.76) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 14 (82.35) | 24.3611 |
2020's | 1 (5.88) | 2.80 |
Authors | Studies |
---|---|
Montouris, G | 1 |
Aboumatar, S | 1 |
Burdette, D | 1 |
Kothare, S | 1 |
Kuzniecky, R | 1 |
Rosenfeld, W | 1 |
Chung, S | 1 |
Cramer, JA | 1 |
Sapin, C | 1 |
François, C | 1 |
Conry, JA | 2 |
Ng, YT | 4 |
Kernitsky, L | 2 |
Mitchell, WG | 1 |
Veidemanis, R | 1 |
Drummond, R | 3 |
Isojarvi, J | 4 |
Lee, D | 4 |
Paolicchi, JM | 1 |
Tolbert, D | 1 |
Harris, SI | 1 |
Bekersky, I | 1 |
Trivisano, M | 1 |
Specchio, N | 1 |
Vigevano, F | 1 |
Maeda, S | 1 |
Tomoyasu, Y | 1 |
Higuchi, H | 1 |
Ishii-Maruhama, M | 1 |
Egusa, M | 1 |
Miyawaki, T | 1 |
Peng, G | 1 |
Sperling, MR | 1 |
Stolle, J | 1 |
Weinberg, MA | 1 |
Traynor, K | 1 |
Seif-Eddeine, H | 1 |
Yang, LP | 1 |
Scott, LJ | 1 |
Conry, J | 1 |
Paolicchi, J | 1 |
Mitchell, W | 1 |
Owen, R | 1 |
Owen, RT | 1 |
de Leon, J | 1 |
Spina, E | 1 |
Diaz, FJ | 1 |
Gyuris, J | 1 |
Csémi, K | 1 |
Munn, R | 1 |
Camfield, P | 1 |
Camfield, C | 1 |
Dooley, J | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome[NCT00518713] | Phase 3 | 238 participants (Actual) | Interventional | 2007-08-31 | Completed | ||
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome[NCT01160770] | Phase 3 | 267 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. (NCT00518713)
Timeframe: 4-week baseline period and 12-week maintenance period
Intervention | Percent Reduction (Least Squares Mean) |
---|---|
Clobazam Low Dose | 41.2 |
Clobazam Medium Dose | 49.4 |
Clobazam High Dose | 68.3 |
Placebo | 12.1 |
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. (NCT00518713)
Timeframe: 4-week baseline period and the first 4 weeks of the 12-week maintenance period
Intervention | Percent reduction (Least Squares Mean) |
---|---|
Clobazam Low Dose | 47.8 |
Clobazam Medium Dose | 58.9 |
Clobazam High Dose | 71.0 |
Placebo | 18.6 |
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. (NCT00518713)
Timeframe: 4-week baseline period and the last 4 weeks of the 12-week maintenance period
Intervention | Percent reduction (Least Squares Mean) |
---|---|
Clobazam Low Dose | 31.8 |
Clobazam Medium Dose | 56.0 |
Clobazam High Dose | 68.0 |
Placebo | -0.1 |
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. (NCT00518713)
Timeframe: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Intervention | Percent reduction (Least Squares Mean) |
---|---|
Clobazam Low Dose | 44.1 |
Clobazam Medium Dose | 38.8 |
Clobazam High Dose | 64.9 |
Placebo | 21.1 |
This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. (NCT00518713)
Timeframe: 4-week baseline period and the 12-week maintenance period
Intervention | Percent reduction (Least Squares Mean) |
---|---|
Clobazam Low Dose | -53.3 |
Clobazam Medium Dose | -3.3 |
Clobazam High Dose | 40.0 |
Placebo | -76.3 |
This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition. (NCT00518713)
Timeframe: 4-week baseline period and 12-week maintenance period
Intervention | Percent reduction (Least Squares Mean) |
---|---|
Clobazam Low Dose | 34.8 |
Clobazam Medium Dose | 45.3 |
Clobazam High Dose | 65.3 |
Placebo | 9.3 |
"The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse." (NCT00518713)
Timeframe: Week 15
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
Clobazam High Dose | 8 | 23 | 8 | 6 | 3 | 1 | 0 |
Clobazam Low Dose | 4 | 20 | 13 | 12 | 2 | 1 | 0 |
Clobazam Medium Dose | 10 | 27 | 9 | 9 | 2 | 0 | 0 |
Placebo | 3 | 10 | 13 | 22 | 6 | 1 | 0 |
"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse." (NCT00518713)
Timeframe: Week 15
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
Clobazam High Dose | 11 | 18 | 11 | 4 | 3 | 2 | 0 |
Clobazam Low Dose | 8 | 14 | 20 | 8 | 2 | 0 | 1 |
Clobazam Medium Dose | 13 | 19 | 14 | 7 | 2 | 2 | 0 |
Placebo | 4 | 10 | 11 | 21 | 6 | 3 | 0 |
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. (NCT00518713)
Timeframe: 4-week baseline period and the 12-week maintenance period
Intervention | Percent of responders (Number) | |||
---|---|---|---|---|
≥ 25% reduction | ≥ 50% reduction | ≥ 75% reduction | 100% reduction | |
Clobazam High Dose | 41 | 38 | 31 | 12 |
Clobazam Low Dose | 34 | 23 | 15 | 4 |
Clobazam Medium Dose | 46 | 34 | 22 | 7 |
Placebo | 28 | 18 | 6 | 2 |
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. (NCT00518713)
Timeframe: 4-week baseline period and the first 4 weeks of the 12-week maintenance period
Intervention | Percent of responders (Number) | |||
---|---|---|---|---|
≥ 25% reduction | ≥ 50% reduction | ≥ 75% reduction | 100% reduction | |
Clobazam High Dose | 89.8 | 77.6 | 63.3 | 30.6 |
Clobazam Low Dose | 71.7 | 47.2 | 35.8 | 13.2 |
Clobazam Medium Dose | 82.8 | 72.4 | 44.8 | 19.0 |
Placebo | 52.6 | 31.6 | 14.0 | 3.5 |
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. (NCT00518713)
Timeframe: 4-week baseline period and the last 4 weeks of the 12-week maintenance period
Intervention | Percent Responders (Number) | |||
---|---|---|---|---|
≥ 25% reduction | ≥ 50% reduction | ≥ 75% reduction | 100% reduction | |
Clobazam High Dose | 71.4 | 67.3 | 57.1 | 20.4 |
Clobazam Low Dose | 66.0 | 45.3 | 28.3 | 13.2 |
Clobazam Medium Dose | 60.3 | 50.0 | 36.2 | 15.5 |
Placebo | 43.9 | 29.8 | 12.3 | 5.3 |
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. (NCT00518713)
Timeframe: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Intervention | Percent Responders (Number) | |||
---|---|---|---|---|
≥ 25% reduction | ≥ 50% reduction | ≥ 75% reduction | 100% reduction | |
Clobazam High Dose | 75.5 | 71.4 | 59.2 | 26.5 |
Clobazam Low Dose | 64.2 | 43.4 | 28.3 | 9.4 |
Clobazam Medium Dose | 65.5 | 51.7 | 34.5 | 15.5 |
Placebo | 50.9 | 24.6 | 12.3 | 5.3 |
Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period. (NCT00518713)
Timeframe: 4-week baseline period and first 4/first 8 weeks of the maintenance period
Intervention | Participants (Number) | |
---|---|---|
≥ 50% reduction - first 4 weeks of maintenance | ≥ 50% reduction - first 8 weeks of maintenance | |
Clobazam High Dose | 38 | 38 |
Clobazam Low Dose | 25 | 23 |
Clobazam Medium Dose | 42 | 38 |
Placebo | 18 | 20 |
Number of drop seizures was obtained from seizure diaries (NCT01160770)
Timeframe: Baseline to month 36
Intervention | percentage of drop seizures (Median) |
---|---|
Clobazam | 92.3 |
Number of drop seizures was obtained from seizure diaries (NCT01160770)
Timeframe: Baseline to month 36
Intervention | percentage of drop seizures (Median) |
---|---|
Clobazam | 92.7 |
"The physician was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse." (NCT01160770)
Timeframe: Baseline to month 36
Intervention | percentage of participants (Number) | ||||||
---|---|---|---|---|---|---|---|
VERY MUCH IMPROVED | MUCH IMPROVED | MINIMALLY IMPROVED | NO CHANGE | MINIMALLY WORSE | MUCH WORSE | VERY MUCH WORSE | |
Clobazam | 35.0 | 45.3 | 14.6 | 2.2 | 0.7 | 1.5 | 0.7 |
"The parent/caregiver was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse." (NCT01160770)
Timeframe: Baseline to month 36
Intervention | percentage of participants (Number) | ||||||
---|---|---|---|---|---|---|---|
VERY MUCH IMPROVED | MUCH IMPROVED | MINIMALLY IMPROVED | NO CHANGE | MINIMALLY WORSE | MUCH WORSE | VERY MUCH WORSE | |
Clobazam | 45.3 | 35.0 | 11.7 | 3.6 | 1.5 | 2.9 | 0.0 |
Number of drop seizures obtained from seizure diaries (NCT01160770)
Timeframe: Baseline to month 36
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Any reduction | ≥25% reduction | ≥50% reduction | ≥75% reduction | 100% reduction | |
Clobazam | 85.8 | 82.3 | 77.9 | 64.6 | 38.1 |
Number of drop seizures obtained from seizure diaries (NCT01160770)
Timeframe: Baseline to month 36
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Any reduction | ≥25% reduction | ≥50% reduction | ≥75% reduction | 100% reduction | |
Clobazam | 86.0 | 83.5 | 79.3 | 64.5 | 31.4 |
7 reviews available for clobazam and Deficiency, Mental
Article | Year |
---|---|
Expert opinion: Proposed diagnostic and treatment algorithms for Lennox-Gastaut syndrome in adult patients.
Topics: Algorithms; Anticonvulsants; Clinical Trials as Topic; Clobazam; Electroencephalography; Expert Test | 2020 |
Indirect comparison of clobazam and other therapies for Lennox-Gastaut syndrome.
Topics: Anticonvulsants; Benzodiazepines; Clobazam; Databases, Factual; Dose-Response Relationship, Drug; Eu | 2013 |
Clobazam (Onfi) for Lennox-Gastaut syndrome.
Topics: Animals; Anticonvulsants; Benzodiazepines; Clobazam; Humans; Intellectual Disability; Lennox Gastaut | 2012 |
Clobazam for patients with Lennox-Gastaut syndrome and epilepsy.
Topics: Anticonvulsants; Benzodiazepines; Clinical Trials as Topic; Clobazam; Drug Interactions; Electroence | 2012 |
Clobazam : in patients with Lennox-Gastaut syndrome.
Topics: Administration, Oral; Anticonvulsants; Benzodiazepines; Biological Availability; Clobazam; Humans; I | 2012 |
The use of clobazam as an adjunctive treatment for Lennox-Gastaut syndrome.
Topics: Anticonvulsants; Benzodiazepines; Clobazam; Drug Interactions; Humans; Intellectual Disability; Lenn | 2012 |
Clobazam therapeutic drug monitoring: a comprehensive review of the literature with proposals to improve future studies.
Topics: Animals; Anticonvulsants; Aryl Hydrocarbon Hydroxylases; Benzodiazepines; Clobazam; Cytochrome P-450 | 2013 |
4 trials available for clobazam and Deficiency, Mental
Article | Year |
---|---|
Stable dosages of clobazam for Lennox-Gastaut syndrome are associated with sustained drop-seizure and total-seizure improvements over 3 years.
Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Female; Huma | 2014 |
Clobazam-treated patients with Lennox-Gastaut syndrome experienced fewer seizure-related injuries than placebo patients during trial OV-1012.
Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Dose-Respons | 2016 |
Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome.
Topics: Adolescent; Adult; Anticonvulsants; Australia; Benzodiazepines; Child; Child, Preschool; Clobazam; D | 2011 |
Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study.
Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Female; Huma | 2012 |
6 other studies available for clobazam and Deficiency, Mental
Article | Year |
---|---|
Withdrawal-related adverse events from clinical trials of clobazam in Lennox-Gastaut syndrome.
Topics: Adult; Aged; Anticonvulsants; Anxiety Disorders; Benzodiazepines; Clobazam; Drug-Related Side Effect | 2014 |
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 |
Independent predictors of delay in emergence from general anesthesia.
Topics: Adult; Ambulatory Care; Anesthesia, Dental; Anesthesia, General; Anesthetics, Inhalation; Anesthetic | 2015 |
Clobazam approved for seizure disorder.
Topics: Anticonvulsants; Benzodiazepines; Child, Preschool; Clobazam; Drug Approval; Humans; Intellectual Di | 2011 |
[Eating epilepsy].
Topics: Adult; Anti-Anxiety Agents; Anticonvulsants; Benzodiazepines; Benzodiazepinones; Clobazam; Drug Ther | 1984 |
Clobazam for refractory childhood seizure disorders--a valuable supplementary drug.
Topics: Adolescent; Adult; Anti-Anxiety Agents; Benzodiazepines; Benzodiazepinones; Child; Child, Preschool; | 1988 |