MedPath

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

Clobazam Use in Epilepsia Partialis Continua - Pilot Study

Phase 3
Terminated
Conditions
Epilepsia Partialis Continua
Kojewnikov's Epilepsy
Epilepsy
Interventions
First Posted Date
2014-05-09
Last Posted Date
2018-05-09
Lead Sponsor
The Cooper Health System
Target Recruit Count
7
Registration Number
NCT02134366
Locations
🇺🇸

Cooper Universtiy Hospital, Camden, New Jersey, United States

Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy

Phase 4
Conditions
Refractory Epilepsy
Interventions
Drug: Initial conversion and titration
Drug: Conversion schedule - Week 1
Drug: Conversion schedule - Week 2
Drug: Conversion schedule - Week 3
First Posted Date
2013-08-30
Last Posted Date
2017-03-03
Lead Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Target Recruit Count
21
Registration Number
NCT01932502
Locations
🇺🇸

Banner Health, Phoenix, Arizona, United States

GABAergic Modulation in Pain Transmission in Human: Effect of the GABAA Agonist Clobazam on Peripheral and Central Sensitisation

Phase 1
Completed
Conditions
Neuropathic Pain
Interventions
First Posted Date
2011-02-08
Last Posted Date
2011-12-14
Lead Sponsor
University Hospital, Geneva
Target Recruit Count
25
Registration Number
NCT01291316
Locations
🇨🇭

University Hospitals, Geneva, Switzerland

Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio)

Phase 3
Completed
Conditions
Low Back Pain
Interventions
First Posted Date
2010-08-11
Last Posted Date
2016-04-06
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
150
Registration Number
NCT01179828
Locations
🇨🇭

Andreas Siegenthaler, Dep. of Anesthesiolgy and Pain therapy, Bern University Hospital, Switzerland

Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

Phase 3
Completed
Conditions
Lennox-Gastaut Syndrome
Interventions
First Posted Date
2010-07-12
Last Posted Date
2018-03-21
Lead Sponsor
Lundbeck LLC
Target Recruit Count
267
Registration Number
NCT01160770

Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers

Phase 3
Completed
Conditions
Pain
Interventions
First Posted Date
2009-11-11
Last Posted Date
2010-08-11
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
17
Registration Number
NCT01011036
Locations
🇨🇭

Dep of Anesthesiology and Pain Therapy, University Hospital Bern, Bern, Switzerland

Clobazam in Patients With Lennox-Gastaut Syndrome

Phase 3
Completed
Conditions
Epilepsy
Epilepsy, Generalized
Seizures
Interventions
First Posted Date
2007-08-21
Last Posted Date
2012-02-09
Lead Sponsor
Lundbeck LLC
Target Recruit Count
238
Registration Number
NCT00518713
Locations
🇺🇸

Children's Memorial Hospital, Chicago, Illinois, United States

🇺🇸

Baylor College of Medicine Pediatric Neurology, Houston, Texas, United States

🇺🇸

Jefferson Epilepsy Center, Philadelphia, Pennsylvania, United States

and more 50 locations

Clobazam in Subjects With Lennox-Gastaut Syndrome

Phase 2
Completed
Conditions
Epilepsy
Epilepsy, Generalized
Seizures
Interventions
First Posted Date
2005-09-13
Last Posted Date
2012-02-09
Lead Sponsor
Lundbeck LLC
Target Recruit Count
68
Registration Number
NCT00162981
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

University of Tennessee Health Science Center, Memphis, Tennessee, United States

🇺🇸

Dallas Pediatric Neurology Associates, Dallas, Texas, United States

and more 11 locations
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