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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: UCB Pharma

Current Primary Outcome: Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements.

Original Primary Outcome: PLMI

Current Secondary Outcome: Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1.

Original Secondary Outcome:

Information By: UCB Pharma

Dates:
Date Received: January 10, 2006
Date Started: November 2005
Date Completion:
Last Updated: September 24, 2014
Last Verified: September 2009