Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome
The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless leg syndrome (RLS). Additional objectives are to investigate the safety and tolerability of rotigotine.
The primary variables are the absolute change from Baseline in the International Restless Legs Severity Scale (IRLS) sum score and Clinical Global Impression-Global Improvement (CGI) Item 1 (severity of illness) score at the end of the Maintenance Period.
Subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in a 1:1:1:1 (active:placebo) fashion. Approximately 450 subjects will be enrolled in this trial, participating at approximately 50 sites. The maximum duration of the trial is approximately 8 months (3-week Titration Period, 6-month Maintenance Period, 7-day Taper Period, and 30-day Safety Follow-Up Period). Subjects who complete the 6-month Maintenance Period will be eligible to participate in an open-label extension trial. Subjects who do not complete the 6-month Maintenance Period or who choose not to participate in the open-label extension trial will complete a 3-day Safety Follow-Up Period. Two different patch sizes will be used (5 and 10 cm2). Active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of rotigotine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multi-center, Randomized, Double-blind, Placebo-controlled, Four-arm Parallel-group Trial to Investigate the Efficacy and Safety of Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome|
- IRLS sum score and CGI Item 1 score severity of illness [ Time Frame: From Baseline at the end of the Maintenance Period ]
- IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score from Baseline at the end of the Maintenance Period
- Changes in CGI Items 2-3 (continuous) during the Maintenance Period; Change from Baseline in RLS-6 Rating Scales at the end of the Maintenance Period
- CGI Item 1 Responder: A responder is a subject with a decrease of ≥50% in CGI Item 1 at the end of the Maintenance Period
|Study Start Date:||May 2005|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|