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

PHASE3CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Lennox-Gastaut Syndrome
Interventions
DRUG

Clobazam

Clobazam will be provided in 5 mg, 10 mg and 20 mg tablets and will be dispensed in bottles as needed at each visit. Bottles may be dispensed between visits if necessary. Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must maintain the dose level for 48 hours. After the first 48 hours of the treatment period, investigators will be able to increase, decrease or maintain the subject's dose, up to an approximate maximum daily dose of 2.0 mg/kg (maximum dose of 80 mg/day).

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lundbeck LLC

INDUSTRY