Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome

Phase 3

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT00136045
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-26
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2010-02
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 549

Inclusion Criteria

• Idiopathic RLS

Exclusion Criteria

• History of sleep disturbances

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IRLS sum score and CGI Item 1 score severity of illness	From Baseline at the end of the Maintenance Period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Schwarz; 🇩🇪 Monheim, Germany