Parkinson's Disease Clinical Trial
Official title:
A Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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