CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 295 enrolled
Drug / intervention
Rotigotinedrug
Likely dose
Rotigotine 0.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00498186
NCT00498186Phase 2Completed
CompareCT.gov

An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

UCB Pharma·interventional·Posted Jul 9, 2007·Updated Oct 2, 2014

In Brief

A Phase 2 clinical trial evaluating Rotigotine for Restless Legs Syndrome. Completed, enrolled 295 participants across 24 sites in 3 countries.

Detailed Summary

This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesAustria, Germany, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2007
Enrollment StartJul 1, 2003
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 19.0 years ago

Interventions

Rotigotinedrug

Rotigotine transdermal patches once daily: 2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)