NCT00498186

Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 295 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine	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)

Timeline

• Start date: 2003-07-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-07-09
• Last updated: 2014-10-02
• Results posted: 2010-04-13

Locations

24 sites across 3 countries: Austria, Germany, Spain