NCT00375284

A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Pramipexole

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-07-01
• First posted: 2006-09-12
• Last updated: 2013-10-31

Locations

52 sites across 1 country: United States