drugset / Trial / 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.)

NCT00152958

Phase 3 Completed 224 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2004-01
Primary completion
2005-02
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Pramipexole Unknown Oral