NCT00135993

Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 811 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine. Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-08-26
• Last updated: 2014-09-25

Locations

1 site across 1 country: United States