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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks
1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks
Advent Research
Pinellas Park, Florida, United States
Medical College of Georgia Movements Disorders Program
Augusta, Georgia, United States
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, United States
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12
The IRLS is a 10-question scale that contains questions about both the frequency and severity of RLS symptoms, as well as secondary aspects such as sleep quality and daytime tiredness.
Time frame: Screening, Baseline, Week 6, Week 12
Tolerability (ability to complete study on assigned dosage)
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Change in Beck Depression Inventory from Baseline to Week 12
Time frame: Baseline, Week 6, Week 12
Change in Clinical Global Impression - Change from Baseline to Weeks 12
Time frame: Baseline, Week 6, Week 12
Change in Medical Outcome Study Sleep Scale from Baseline to Week 12
Time frame: Baseline, Week 6, Week 12
Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12
Time frame: Baseline, week 6, Week 12
Change in Epworth Sleepiness Scale from Baseline to Week 12
Time frame: Baseline, Week 6, Week 12
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Atlantic Neuroscience Institute Overlook Hospital
Summit, New Jersey, United States
SUNY- Buffalo Jacobs Neurological Institute
Buffalo, New York, United States
Cleveland Clinic Sleep Disorders Center
Cleveland, Ohio, United States
University of Pennsylvania Sleep Center
Philadelphia, Pennsylvania, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States