Conditions: Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 723
Healthy volunteers: no

Brief summary:
Randomised, double-blind, double dummy, parallel group design. Following the screening period patients will be randomised at the baseline visit, in a 1:1:1 manner, to one of three treatment arms; 4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo. The first 4 weeks of the double blind phase will be used to titrate patients on the E2007 arm from 2 mg up to the maintenance dose of 4 mg. Patients randomised to entacapone or placebo will have dummy up titrations to maintain the blind. Following this titration phase, patients will remain on the maintenance dose for a further 14 weeks.

Patients will have visits at 2, 4, 6, 10, 14 and 18 weeks after baseline. A follow up visit will be performed at Week 22.

A home diary will be completed in which patients rate themselves as either:

1. "OFF"
2. "ON" without dyskinesias
3. "ON" with non-troublesome dyskinesias
4. "ON" with troublesome dyskinesias
5. Asleep

These entries will be completed every 30 minutes during the waking day and will be completed for three consecutive days immediately prior to visits at Baseline, Weeks 6, 10, 18 and 22.

At Baseline (Day 0), week 10 and 18 the Unified Parkinson's Disease Rating Scale (UPDRS - Parts I, II , III and IV) will be performed.

At the end of the treatment period (Week 18), patients will undergo final efficacy and safety assessments and will stop taking the study medication they were receiving. They will be seen 4 weeks later for a follow up visit.

Detailed description:

Arms:
arm 1: matching E2007 and matching entacapone arm 2: 2 mg once daily in the evening, Weeks 0→2 (2 weeks) and 4 mg once daily in the evening, Weeks 2→18. arm 3: 200 mg with each dose of Levodopa.

Interventions: intervention 1: Placebo intervention 2: E2007 intervention 3: E2007
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: