Conditions: Epilepsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 133
Healthy volunteers: no

Brief summary:
This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.

Detailed description:
This study consisted of the Core Study and the Extension Part A and B. The Core Study consisted of 2 phases: Prerandomization and Randomization. The Prerandomization Phase lasted up to 1 week, during which participants were assessed for their eligibility to participate in the study. The Randomization Phase consisted of 3 periods: Titration (6 weeks), Maintenance (13 weeks), and Follow-up (4 weeks; only for those participants not rolling over into the Extension Phase). During the Core Study Titration and Maintenance Periods, participants were randomized into perampanel (2 to 12 mg per day) or placebo treatment groups in a 2:1 ratio within each of the age-matched categories (ie, greater than or equal to 12 to less than 15 and greater than or equal to 15 to less than 18).

The extension phase consisted of part A (Conversion Period - 6 weeks and Maintenance period - 25 weeks) and Part B (Optional Extension Phase -52 weeks). The maximum duration for participation in Part B was 52 weeks.

Arms:
arm 1: Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day. arm 2: Participants received matching placebo tablets once a day (6 tablets of placebo). arm 3: During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.

Interventions: intervention 1: Perampanel intervention 2: Placebo
Intervention descriptions: intervention 1: 2 mg titrated up to 8-12 mg maximum; taken once daily. intervention 2: Matching Placebo taken once daily.

Protocol document: