Conditions: Epilepsy
Keywords: Epilepsy: partial onset seizures brivaracetam
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 210
Healthy volunteers: no

Brief summary:
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Detailed description:

Arms:
arm 1: Matching Placebo tablets administered twice a day arm 2: Brivaracetam 5 mg/day, 2.5 mg administered twice a day arm 3: Brivaracetam 20 mg/day, 10 mg administered twice a day arm 4: Brivaracetam 50 mg/day, 25 mg administered twice a day

Interventions: intervention 1: Placebo intervention 2: Brivaracetam
Intervention descriptions: intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period

Protocol document: