NCT00356096

Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances

A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 404 (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 determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment

Conditions

• Restless Legs Syndrome
• Depression

Interventions

Type	Name	Description
DRUG	pramipexole

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-06-01
• First posted: 2006-07-25
• Last updated: 2012-05-21

Locations

54 sites across 9 countries: Finland, France, Germany, Ireland, Italy, South Korea, Spain, Sweden, United Kingdom