Conditions: Refractory Partial Seizures
Keywords: E2007 (perampanel) refractory partial seizures adjunctive therapy seizure frequency reduction in seizure frequency partial onset seizures safety concomitant AED(s)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 389
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: E2007 (perampanel) intervention 2: E2007 (perampanel) intervention 3: Placebo
Intervention descriptions: intervention 1: 8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 2: 12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 3: Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.

Protocol document: