Clinical Trials Directory

Trials / Completed

CompletedNCT00654498

Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)

A Randomized, Double-blind, Placebo Controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally q.n. to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks

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

Summary

To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)

Conditions

Interventions

TypeNameDescription
DRUGPramipexole
DRUGPlacebo

Timeline

Start date
2008-04-01
Primary completion
2009-06-01
Completion
2009-06-01
First posted
2008-04-08
Last updated
2014-06-09
Results posted
2010-03-03

Locations

16 sites across 1 country: China

Source: ClinicalTrials.gov record NCT00654498. Inclusion in this directory is not an endorsement.

Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS) (NCT00654498) · Clinical Trials Directory