NCT00275457

Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients

A Randomised, Double-blind, Placebo-controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-label or Double-blind Treatment Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (planned)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.

Detailed description

To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks open label or double blind extension Study Hypotheses: Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment. Comparison(s): Pramipexole vs. Placebo

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	pramipexole

Timeline

• Start date: 2002-10-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2006-01-12
• Last updated: 2013-10-31

Locations

34 sites across 5 countries: Austria, Germany, Netherlands, Norway, Sweden