NCT00152997

Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to investigate the efficacy and safety of pramipexole (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese version of the RLS rating scale by the International Restless Legs Syndrome Study Group (IRLSSG) as a sub-study.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Pramipexole 0.125 mg tablets
DRUG	Pramipexole 0.125 mg tablets Placebo

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-12-01
• First posted: 2005-09-12
• Last updated: 2013-10-31

Locations

7 sites across 1 country: Japan