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Clobazam

Generic Name
Clobazam
Brand Names
Onfi, Sympazan
Drug Type
Small Molecule
Chemical Formula
C16H13ClN2O2
CAS Number
22316-47-8
Unique Ingredient Identifier
2MRO291B4U
Background

Clobazam belongs to the 1,5-benzodiazepine class of drugs and is marketed under different names, Onfi, Frisium, Urbanyl, and others.. Clobazam was first synthesized in 1966 and first published in 1969, following the incidental synthesis and discovery of the first benzodiazepine chlordiazepoxide in the 1950s. Unlike older 1,4-benzodiazepines, clobazam has a better side-effects profile, particularly less sedative and amnesic effects. This is likely because of clobazam's higher affinity to the α subunit of the GABA receptor, which mediates anxiolytic effects, than the α subunit, which mediates sedative effect. Additionally, clobazam is believed to be a partial agonist to the GABA receptor rather than non-selective full receptor agonists like 1,4-benzodiazepines, thus potentially explaining the decreased incidence of sedative effects.

Clobazam has been marketed as an anxiolytic since 1975 and an anticonvulsant since 1984. In October 21, 2011, the FDA approved clobazam as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in adults and children aged two years and older. In 2005, clobazam also received approval from Health Canada as an add-on therapy for generalized tonic-clonic, myoclonic, and focal impaired awareness seizures.

Indication

Clobazam is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

Associated Conditions
Anxiety, Catamenial Epilepsy, Refractory Status Epilepticus, Seizures, Status Epilepticus

The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children

First Posted Date
2023-01-26
Last Posted Date
2023-01-26
Lead Sponsor
Dr Cipto Mangunkusumo General Hospital
Target Recruit Count
100
Registration Number
NCT05697614
Locations
🇮🇩

Cipto Mangunkusumo Hospital, Jakarta Pusat, Jakarta, Indonesia

🇮🇩

Harapan Kita Hospital, Jakarta, Indonesia

🇮🇩

Fatmawati Hospital, Jakarta, Indonesia

GABA Pathways in Autism Spectrum Disorder (ASD)

Not Applicable
Recruiting
Conditions
Autism Spectrum Disorder
Interventions
Drug: AZD7325_10
Drug: AZD7325_20
Drug: Placebo
First Posted Date
2018-09-19
Last Posted Date
2023-09-26
Lead Sponsor
King's College London
Target Recruit Count
50
Registration Number
NCT03678129
Locations
🇬🇧

King's College London, London, United Kingdom

Use of Clobazam for Epilepsy and Anxiety

Phase 4
Completed
Conditions
Epilepsy
Anxiety
Interventions
First Posted Date
2017-12-13
Last Posted Date
2021-03-04
Lead Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Target Recruit Count
20
Registration Number
NCT03371836
Locations
🇺🇸

Kennedy Krieger Institute, Baltimore, Maryland, United States

Clobazam Adjunctive Treatment of Adults With Refractory Focal Epilepsy

Phase 4
Conditions
Epilepsy
Interventions
First Posted Date
2016-04-04
Last Posted Date
2017-03-23
Lead Sponsor
Pavel Klein
Target Recruit Count
20
Registration Number
NCT02726919
Locations
🇺🇸

MidAtlantic Epilepsy and Sleep Center, Bethesda, Maryland, United States

A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

Phase 2
Completed
Conditions
Epilepsy
Interventions
Drug: GWP42003-P 20 mg/kg/Day Dose
Drug: Placebo
First Posted Date
2015-10-01
Last Posted Date
2022-09-28
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
20
Registration Number
NCT02565108

An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

Phase 2
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2015-10-01
Last Posted Date
2022-09-28
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
18
Registration Number
NCT02564952

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations

Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

Phase 3
Terminated
Conditions
Dravet Syndrome
Interventions
First Posted Date
2014-07-11
Last Posted Date
2017-03-27
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
3
Registration Number
NCT02187809
Locations
🇺🇸

US010, Los Angeles, California, United States

🇺🇸

US003, Rochester, Minnesota, United States

🇺🇸

US0011, Dallas, Texas, United States

and more 6 locations

Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

Phase 3
Withdrawn
Conditions
Dravet Syndrome
Interventions
Drug: Placebo
First Posted Date
2014-06-25
Last Posted Date
2015-09-24
Lead Sponsor
H. Lundbeck A/S
Registration Number
NCT02174094
Locations
🇺🇸

US003, Rochester, Minnesota, United States

🇺🇸

US006, Dallas,, Texas, United States

🇺🇸

US010, Los Angeles, California, United States

and more 6 locations
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