Conditions: Epilepsy
Keywords: Epilepsy Brivaracetam Partial Onset Seizures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 399
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

Detailed description:

Arms:
arm 1: Matching Placebo tablets administered twice a day arm 2: Brivaracetam 20 mg/day, 10 mg administered twice a day arm 3: Brivaracetam 50 mg/day, 25 mg administered twice a day arm 4: Brivaracetam 100 mg/day, 50 mg administered twice a day

Interventions: intervention 1: Placebo intervention 2: Brivaracetam intervention 3: Brivaracetam intervention 4: Brivaracetam
Intervention descriptions: intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period intervention 3: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period. intervention 4: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.

Protocol document: