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

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00135993
• Collaborator: (none)
• Enrollment: 811
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 45

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: Rotigotine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 811 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. IRLS sum score and CGI Item 1 score severity of illness [From Baseline at the end of the Maintenance Period]

Secondary Outcome Measures

1. 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]

2. 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]

3. 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Idiopathic restless legs syndrome

Exclusion Criteria:

• History of sleep disturbances

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schwarz	RTP	North Carolina	United States

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center, UCB Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00135993
• Other Study ID Numbers: SP0792
• First Posted: Aug 26, 2005
• Last Update Posted: Sep 25, 2014
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Idiopathic Restless Leg syndrome
• Additional relevant MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Rotigotine

Study Results

No Results Posted as of Sep 25, 2014