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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- UCB Pharma
- Enrollment
- 811
- Locations
- 1
- Primary Endpoint
- IRLS sum score and CGI Item 1 score severity of illness
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Idiopathic restless legs syndrome
Exclusion Criteria
- •History of sleep disturbances
Outcomes
Primary Outcomes
IRLS sum score and CGI Item 1 score severity of illness
Time Frame: From Baseline at the end of the Maintenance Period
Secondary Outcomes
- 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