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 and older. Per ClinicalTrials.gov, last updated 2014-09-25.
Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial.
All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose.
A subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 279 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.
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Exclusion Criteria:
Up to 6.75 mg/day (optimal dosing)
Drug: Rotigotine
Transdermal Patch 1 per day for 24 hours containing: 1.125mg/day 2.25mg/day 4.5mg/day 6.75mg/day
Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating
Time frame: 1 year
To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period.
Time frame: 1 year
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