Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
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|ClinicalTrials.gov Identifier: NCT00135993|
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : September 25, 2014
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||811 participants|
|Intervention Model:||Parallel Assignment|
|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 2005|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
- IRLS sum score and CGI Item 1 score severity of illness [ Time Frame: From Baseline at the end of the Maintenance Period ]
- IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135993
|United States, North Carolina|
|RTP, North Carolina, United States|
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|