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

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00136045
• Collaborator: (none)
• Enrollment: 549
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 36.6

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 549 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Aug 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. 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 []

3. 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 []

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Idiopathic RLS

Exclusion Criteria:

• History of sleep disturbances

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schwarz	Monheim		Germany

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: NCT00136045
• Other Study ID Numbers: SP0790; 2005-000428-18
• First Posted: Aug 26, 2005
• Last Update Posted: Sep 25, 2014
• Last Verified: Feb 1, 2010

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

Study Results

No Results Posted as of Sep 25, 2014