Conditions: Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 752
Healthy volunteers: no

Brief summary:
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.

Detailed description:

Arms:
arm 1: The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening. arm 2: The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening. arm 3: The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.

Interventions: intervention 1: 2 mg perampanel intervention 2: 4 mg perampanel intervention 3: placebo comparator
Intervention descriptions: intervention 1: 2 mg perampanel intervention 2: 4 mg perampanel intervention 3: placebo comparator

Protocol document: