clobazam and Spasms, Infantile 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.

Spasms, Infantile: An epileptic syndrome characterized by the triad of infantile spasms, hypsarrhythmia, and arrest of psychomotor development at seizure onset. The majority present between 3-12 months of age, with spasms consisting of combinations of brief flexor or extensor movements of the head, trunk, and limbs. The condition is divided into two forms: cryptogenic (idiopathic) and symptomatic (secondary to a known disease process such as intrauterine infections; nervous system abnormalities; BRAIN DISEASES, METABOLIC, INBORN; prematurity; perinatal asphyxia; TUBEROUS SCLEROSIS; etc.). (From Menkes, Textbook of Child Neurology, 5th ed, pp744-8)

Research Excerpts

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)
"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 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)
"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 mainstay of treatment is with multiple anti-seizure medications (ASMs); however, the ASMs themselves can be associated with psychobehavioural adverse events, and effects (negative or positive) on cognition and sleep."	2.82	Psychobehavioural and Cognitive Adverse Events of Anti-Seizure Medications for the Treatment of Developmental and Epileptic Encephalopathies. ( Schubert-Bast, S; Strzelczyk, A, 2022)
"Interictal EEG showed hypsarrhythmia in 27 infants and multifocal spikes with normal or nearly normal background in 17 infants."	2.70	Infantile spasms: diagnosis and assessment of treatment response by video-EEG. ( Gaily, E; Granström, ML; Liukkonen, E; Paetau, R; Rekola, R, 2001)
"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)
"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)
" This practical guide provides an overview of these main ASMs including their indications/contraindications, mechanism of action, efficacy, safety and tolerability profile, dosage requirements, and laboratory and clinical parameters to be evaluated."	1.72	A Practical Guide to the Treatment of Dravet Syndrome with Anti-Seizure Medication. ( Schubert-Bast, S; Strzelczyk, A, 2022)
"A positive response (seizure-free and >50 % seizure reduction) was determined for focal-onset (62."	1.72	The effectiveness and tolerability of clobazam in the pediatric population: Adjunctive therapy and monotherapy in a large-cohort multicenter study. ( Arslan, EA; Aydın, K; Cansu, A; Çarman, KB; Dilber, B; Dündar, NO; Durgut, BD; Erdoğan, I; Gencpinar, P; Hız, SA; Kamaşak, T; Kılıç, BA; Okuyaz, Ç; Özen, N; Özkan Kart, P; Polat, BG; Şahin, S; Serdaroğlu, A; Serdaroğlu, E; Serin, HM; Tekgül, H; Topçu, Y; Yıldız, N; Yılmaz, Ö; Yücel Şen, AD, 2022)
"Clobazam was introduced after the administration of 2."	1.51	Clobazam as an adjunctive treatment for infantile spasms. ( Chang, MJ; Hahn, J; Kang, HC; Kim, HD; Kim, SH; Lee, H; Lee, JS, 2019)
"Spasms in series and hypsarrhythmia disappeared after treatment with high-dose phenobarbital; however, single spasms persisted with right-sided predominance, and polyspike activity in the left parieto-temporal areas preceded or coincided with these spasms."	1.36	Non-convulsive status epilepticus and audiogenic seizures complicating a patient with asymmetrical epileptic spasms. ( Hoshino, K; Komaki, H; Nakagawa, E; Saito, Y; Sakuma, H; Sasaki, M; Sugai, K, 2010)

Research

Studies (19)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (5.26)	18.2507
2000's	3 (15.79)	29.6817
2010's	12 (63.16)	24.3611
2020's	3 (15.79)	2.80

Authors	Studies
Strzelczyk, A	2
Schubert-Bast, S	2
Kamaşak, T	1
Serdaroğlu, E	1
Yılmaz, Ö	1
Kılıç, BA	1
Polat, BG	1
Erdoğan, I	1
Yücel Şen, AD	1
Özen, N	1
Durgut, BD	1
Yıldız, N	1
Özkan Kart, P	1
Dilber, B	1
Arslan, EA	1
Şahin, S	1
Topçu, Y	1
Gencpinar, P	1
Serin, HM	1
Hız, SA	1
Çarman, KB	1
Dündar, NO	1
Okuyaz, Ç	1
Aydın, K	1
Serdaroğlu, A	1
Tekgül, H	1
Cansu, A	1
Hahn, J	1
Lee, H	1
Kang, HC	1
Lee, JS	1
Kim, HD	1
Kim, SH	1
Chang, MJ	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	2
Lee, D	2
Paolicchi, JM	1
Saito, Y	1
Sugai, K	1
Nakagawa, E	1
Sakuma, H	1
Komaki, H	1
Sasaki, M	1
Hoshino, K	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
Silva, RC	1
Montenegro, MA	1
Guerreiro, CA	1
Guerreiro, MM	1
Siemes, H	1
Brandl, U	1
Spohr, HL	1
Völger, S	1
Weschke, B	1
Dulac, O	1
Gaily, E	1
Liukkonen, E	1
Paetau, R	1
Rekola, R	1
Granström, ML	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

Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 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

Percent Reduction in Number of Drop Seizures (Last 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

Percent Reduction in Number of Drop Seizures (Middle 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

Percent Reduction in the Number of Non-drop Seizures.

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

Percent Reduction of Total (Drop and Non-Drop) Seizures.

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

Investigator Global Evaluations of the Patient's Overall Change in Symptoms.

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

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.

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

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).

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

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (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	41	38	31	12
Clobazam Low Dose	34	23	15	4
Clobazam Medium Dose	46	34	22	7
Placebo	28	18	6	2

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 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

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 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

Tolerance

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

Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment

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

Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment

Intervention	percentage of drop seizures (Median)
Clobazam	92.3

Number of drop seizures was obtained from seizure diaries (NCT01160770)
Timeframe: Baseline to month 36

Investigator Global Evaluations of the Patient's Overall Change in Symptoms

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

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms

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

Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment

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

Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment

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

Article	Year
Psychobehavioural and Cognitive Adverse Events of Anti-Seizure Medications for the Treatment of Developmental and Epileptic Encephalopathies. CNS drugs, 2022, Volume: 36, Issue:10 Topics: Autism Spectrum Disorder; Bromides; Cannabidiol; Clobazam; Cognition; Ethosuximide; Everolimus; Felb	2022
Indirect comparison of clobazam and other therapies for Lennox-Gastaut syndrome. Acta neurologica Scandinavica, 2013, Volume: 128, Issue:2 Topics: Anticonvulsants; Benzodiazepines; Clobazam; Databases, Factual; Dose-Response Relationship, Drug; Eu	2013
Clobazam (Onfi) for Lennox-Gastaut syndrome. The Medical letter on drugs and therapeutics, 2012, Mar-05, Volume: 54, Issue:1385 Topics: Animals; Anticonvulsants; Benzodiazepines; Clobazam; Humans; Intellectual Disability; Lennox Gastaut	2012
Clobazam for patients with Lennox-Gastaut syndrome and epilepsy. Expert review of neurotherapeutics, 2012, Volume: 12, Issue:4 Topics: Anticonvulsants; Benzodiazepines; Clinical Trials as Topic; Clobazam; Drug Interactions; Electroence	2012
Clobazam : in patients with Lennox-Gastaut syndrome. CNS drugs, 2012, Volume: 26, Issue:11 Topics: Administration, Oral; Anticonvulsants; Benzodiazepines; Biological Availability; Clobazam; Humans; I	2012
The use of clobazam as an adjunctive treatment for Lennox-Gastaut syndrome. Drugs of today (Barcelona, Spain : 1998), 2012, Volume: 48, Issue:11 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. Therapeutic drug monitoring, 2013, Volume: 35, Issue:1 Topics: Animals; Anticonvulsants; Aryl Hydrocarbon Hydroxylases; Benzodiazepines; Clobazam; Cytochrome P-450	2013
Epileptic encephalopathy. Epilepsia, 2001, Volume: 42 Suppl 3 Topics: Adolescent; Age Factors; Anti-Anxiety Agents; Anticonvulsants; Benzodiazepines; Brain Diseases; Chil	2001

Article	Year
Stable dosages of clobazam for Lennox-Gastaut syndrome are associated with sustained drop-seizure and total-seizure improvements over 3 years. Epilepsia, 2014, Volume: 55, Issue:4 Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Female; Huma	2014
Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology, 2011, Oct-11, Volume: 77, Issue:15 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. Epilepsy & behavior : E&B, 2012, Volume: 25, Issue:4 Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Child, Preschool; Clobazam; Female; Huma	2012
Long-term follow-up study of vigabatrin in pretreated children with West syndrome. Seizure, 1998, Volume: 7, Issue:4 Topics: Adrenocorticotropic Hormone; Anti-Anxiety Agents; Anticonvulsants; Benzodiazepines; Child, Preschool	1998
Infantile spasms: diagnosis and assessment of treatment response by video-EEG. Developmental medicine and child neurology, 2001, Volume: 43, Issue:10 Topics: Anti-Anxiety Agents; Anticonvulsants; Benzodiazepines; Brain; Carbamazepine; Clobazam; Electroenceph	2001

Article	Year
A Practical Guide to the Treatment of Dravet Syndrome with Anti-Seizure Medication. CNS drugs, 2022, Volume: 36, Issue:3 Topics: Adult; Anticonvulsants; Cannabidiol; Child; Clobazam; Drug Therapy, Combination; Epilepsies, Myoclon	2022
The effectiveness and tolerability of clobazam in the pediatric population: Adjunctive therapy and monotherapy in a large-cohort multicenter study. Epilepsy research, 2022, Volume: 184 Topics: Anticonvulsants; Child; Clobazam; Cohort Studies; Epilepsy; Humans; Retrospective Studies; Seizures;	2022
Clobazam as an adjunctive treatment for infantile spasms. Epilepsy & behavior : E&B, 2019, Volume: 95 Topics: Anticonvulsants; Clobazam; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Infant; Mal	2019
Non-convulsive status epilepticus and audiogenic seizures complicating a patient with asymmetrical epileptic spasms. Brain & development, 2010, Volume: 32, Issue:7 Topics: Anticonvulsants; Benzodiazepines; Brain; Clobazam; Electroencephalography; Epilepsy, Reflex; Female;	2010
Clobazam approved for seizure disorder. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2011, Dec-01, Volume: 68, Issue:23 Topics: Anticonvulsants; Benzodiazepines; Child, Preschool; Clobazam; Drug Approval; Humans; Intellectual Di	2011
Clobazam as add-on therapy in children with epileptic encephalopathy. The Canadian journal of neurological sciences. Le journal canadien des sciences neurologiques, 2006, Volume: 33, Issue:2 Topics: Adolescent; Anticonvulsants; Benzodiazepines; Brain; Child; Child, Preschool; Clobazam; Dose-Respons	2006

clobazam and Spasms, Infantile

Research Excerpts

Research

Studies (19)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).

Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).

Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).

Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).

Percent Reduction in the Number of Non-drop Seizures.

Percent Reduction of Total (Drop and Non-Drop) Seizures.

Investigator Global Evaluations of the Patient's Overall Change in Symptoms.

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).

Tolerance

Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment

Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment

Investigator Global Evaluations of the Patient's Overall Change in Symptoms

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms

Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment

Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment

Reviews

Trials

Other Studies