Conditions: Epilepsy
Keywords: Epilepsy Brivaracetam Partial Onset Seizures, Adolescents & Adults
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 400
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. Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period. arm 2: Brivaracetam 5 mg/day, 2.5 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg /day in a double-blinded way for the 12-week Treatment Period. arm 3: Brivaracetam 20 mg/day, 10 mg administered twice a day. 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. arm 4: Brivaracetam 50 mg/day, 25 mg administered twice a day. 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.

Interventions: intervention 1: Placebo intervention 2: Brivaracetam 2.5 mg intervention 3: Brivaracetam 10 mg intervention 4: Brivaracetam 25 mg
Intervention descriptions: intervention 1: * Active Substance: Placebo
* Pharmaceutical Form: Film-coated tablet
* Concentration: 2.5 mg, 10 mg and 25 mg
* Route of Administration: Oral use intervention 2: * Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 2.5 mg
* Route of Administration: Oral use intervention 3: * Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 10 mg
* Route of Administration: Oral use intervention 4: * Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 25 mg
* Route of Administration: Oral use

Protocol document: