NCT00275236

A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

A Multi-center, Double-blind, Randomized, Placebo-controlled, Two-arm, Parallel-group, Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained from PSGs.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2006-01-11
• Last updated: 2014-09-25

Locations

1 site across 1 country: Germany