Restless Legs Syndrome Clinical Trial
Official title:
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to make sure rasagiline is safe to give people with RLS.
The primary objective is to determine if rasagiline, at a dosage of 1mg/day, is non-futile
for the treatment of RLS, as measured by the International RLS Study Group Rating Scale
(IRLS). The primary outcome variable will be the change in IRLS from baseline to Week 12.
The secondary objectives are to determine if rasagiline, at a dosage of 1mg/day, is safe and
well-tolerated in participants with RLS. Also, to determine if rasagiline improves measures
of global clinical change, sleep quality, excessive sleepiness, quality of life, or
depressive symptoms.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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|---|---|---|---|
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