NCT00349531

A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS

A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-patients With Idiopathic Restless Legs Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to investigate the effects on RLS symptoms and sleep disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Pramipexole

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-05-01
• First posted: 2006-07-07
• Last updated: 2012-05-21

Locations

49 sites across 9 countries: Denmark, Finland, Germany, Ireland, Italy, Norway, Spain, Sweden, United Kingdom