Conditions: Partial Epilepsy Catamenial Epilepsy
Keywords: Partial onset seizures Complex-partial seizures Anticonvulsant Partial seizures Catamenial epilepsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 147
Healthy volunteers: no

Brief summary:
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy.

Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.

Detailed description:

Arms:
arm 1: active study drug arm 2: placebo

Interventions: intervention 1: Ganaxolone intervention 2: Placebo
Intervention descriptions: intervention 1: Oral suspension 200-500 mg 3x/day intervention 2: non-active placebo

Protocol document: