NCT00152958

A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

A Double-blind, Placebo-controlled, Randomised Withdrawal Study of 3 Month Duration in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (planned)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole. Secondary objectives are the measurement of severity of the RLS, assessment of early withdrawal phenomena after termination of trial medication, augmentation under treatment, sleepiness, quality of life and subjective wellbeing, the physician's clinical assessment of symptom severity and improvement. Another secondary objective is safety and tolerability of treatment.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Pramipexole

Timeline

• Start date: 2004-01-01
• Primary completion: 2005-02-01
• First posted: 2005-09-12
• Last updated: 2013-11-19

Locations

12 sites across 1 country: Germany