A Phase 3 interventional study of Rotigotine in Restless Legs Syndrome, sponsored by UCB Pharma. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-09-25.
Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment
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).
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 811 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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UCB Pharma