Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Phase 3

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT00135993
• Lead Sponsor: UCB Pharma

Brief Summary

Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial.

The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine.

Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).

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: 2006-11
• Study Completion: 2006-11
• Status Verified: 2009-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 811

Inclusion Criteria

• Idiopathic restless legs syndrome

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
CGI Item 1 Responder: A responder is defined as a subject with a decrease of ≥50% in CGI Item 1	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

Trial Locations

Locations (1)

Schwarz; 🇺🇸 RTP, North Carolina, United States