Parkinson Disease Clinical Trial
Official title:
A Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With "Wearingoff" Phenomenon Treated With Levodopa/Carbidopa or Levodopa/Benserazide
The purpose of this study was to investigate the effect on the "wearing-off" phenomenon of 3 different doses of nebicapone (NEB 50 mg, 100 mg and 150 mg), compared with entacapone and placebo when dministered concomitantly with existing treatment with levodopa plus a dopa decarboxylase inhibitor (DDCI: carbidopa or benserazide).
The study was conducted in 40 sites in Europe and South America: Argentina (6); Austria (2);
Brazil (5); France (1); Hungary (4); Poland (7); Portugal (2); Romania (7); and Ukraine (6).
Multicentre study with a screening visit (Visit V1), a single-blind placebo run-in period of
1 or 2 weeks (Period 1, Visits V2 to V3), and an 8-week randomised, double-blind, activeand
placebo-controlled, parallel-group (5 groups) treatment period (Period 2, Visits V3 to V7).
In Hungary only: a 1-week tapering-off period was added by amendment #1HU. The dosage of
nebicapone was to be tapered off stepwise during 6 days. This period was to end with a
follow-up Visit V8.
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