Parkinson's Disease (PD) Clinical Trial
Official title:
A Double-blind, Randomised, Placebo- and Active-controlled, Cross-over Study to Investigate the Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients
The purpose of this study is to determine the effect of two different multiple-dose regimens of nebicapone in comparison to placebo and entacapone 200 mg on the pharmacokinetics of levodopa in Parkinson's Disease (PD) patients.
STUDY DESIGN AND METHODOLOGY:
This was a multicentre, randomised, double-blind, placebo- and active-controlled, four-way
crossover study. The study consisted of 4 treatment periods in at least 16 patients with PD
treated with standard release levodopa/carbidopa (Sinemet®). Patients were randomly assigned
to treatment with placebo, nebicapone 75 mg, nebicapone 150 mg or entacapone 200 mg
(Comtan®) in 4 different sequences.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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