Conditions: Epilepsy Epilepsy, Generalized Seizures
Keywords: Epilepsy Lennox-Gastaut Syndrome Drop seizures Clobazam
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 238
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

Detailed description:
LGS poses a significant treatment challenge. No single antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Even with combination therapy, many LGS patients show resistance to treatment. Adjunctive therapy with newer anticonvulsant medications has demonstrated efficacy for some patients, although polytherapy and high medication doses are often associated with unfavorable adverse event profiles.

More effective and better-tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam may provide an improved safety profile compared to other AEDs currently approved for the treatment of LGS and may have less hypotonia and drooling effects than other benzodiazepines.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Clobazam Low Dose intervention 2: Clobazam Medium Dose intervention 3: Clobazam High Dose intervention 4: Placebo
Intervention descriptions: intervention 1: 0.25 mg/kg/day; tablets; orally; for 15-18 weeks intervention 2: 0.5 mg/kg/day; tablets; orally; for 15-18 weeks intervention 3: 1.0 mg/kg/day; tablets; orally; for 15-18 weeks intervention 4: tablets; orally; daily for 15-18 weeks

Protocol document: