Restless Legs Syndrome Clinical Trial
Official title:
A Phase IV Randomised, Double-blind, Active and Placebo-controlled, 6-week Trial to Investigate the Efficacy and Safety of a Starting (and Fixed) Dose 0.25 mg Pramipexole (Mirapex®) in Patients With Idiopathic Restless Legs Syndrome
This trial is a 6-week, double-blind, randomized, active and placebo-controlled
parallel-group study with a primary objective of comparison of starting doses of pramipexole
fixed-dose (0.25 mg daily) and pramipexole titrated-dose (0.125 mg qd for 1 week, then 0.25
mg qd for the remaining 5 weeks) with placebo to evaluate efficacy and safety in treating
RLS symptoms in patients diagnosed with idiopathic RLS.
The secondary objectives of this study will be to assess the onset of action of symptomatic
relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two
intervals of the first 2 weeks (Days 2, 3 and 4 and Days 9, 10, and 11) and assessment of
IRLS, PGI and CGI-I at Weeks 1, 2, 4 and 6 (CGI-I additionally on Day 3).
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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