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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: UCB Pharma
• Treatments: N 0437; Rotigotine

Criteria

Inclusion Criteria:

• Idiopathic RLS

Exclusion Criteria:

• secondary RLS

• history of sleep disturbances

• symptomatic orthostatic hypotension