A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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).