At a glance
ClinicalIndex Comparison Record- ✓Age at LGS onset: <11 years
- ✓Diagnosed with Lennox-Gastaut syndrome
- ✓On at least 1 stable-dose AED at baseline
- ✓Parent or caregiver able to maintain accurate seizure diary
- ✕Seizures due to progressive neurologic disease (except tuberous sclerosis)
- ✕Status epilepticus within 12 weeks of baseline
- ✕Anoxic episode requiring resuscitation within 1 year of screening
- ✕History of allergic reaction or significant sensitivity to benzodiazepines
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
In Brief
A Phase 2 clinical trial evaluating Clobazam Low Dose and Clobazam High Dose for Epilepsy and 2 related conditions. Completed, enrolled 68 participants across 14 sites.
Detailed 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 subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
Study Details
Timeline
Interventions
5 to 10 mg/day with doses in the morning and at bedtime; orally
5 to 40 mg/day with doses in the morning and at bedtime; orally