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

NCT ID: NCT00275457


Title
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
Purpose
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.
Details
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
Keywords
Source
Boehringer Ingelheim
Sponsors
Boehringer Ingelheim
Status
Completed
Acronym
Last Updated
29 Oct 2013
URL
Official Link
Locations
Austria, Germany, Netherlands, Norway, Sweden