Status:
TERMINATED
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Teva Neuroscience, Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- Men and women at least 18 years of age, capable of providing informed consent
- Diagnosed with idiopathic RLS, defined as meeting the International RLS Study Group diagnostic criteria without evidence for secondary causes of RLS
- Moderate or severe symptoms, defined as a score of 15 or greater on the International RLS Study Group Rating Scale (IRLS)
- Not currently receiving treatment for RLS. A 30-day washout period will be required for participants on dopamine agonists or other therapies. Stable doses of iron supplementation will be allowed
- On a stable dose of the following antidepressants, for at least 30 days prior to baseline visit:
- Amitriptyline, up to 50mg/day
- Trazodone, up to 100mg/day
- Citalopram, up to 20mg/day
- Escitalopram, up to 10mg/day
- Paroxetine, up to 30mg/day
- Sertraline, up to 100mg/day
- Female subjects must not be of childbearing potential or must agree to use of contraception for duration of study
Exclusion
- Signs consistent with a secondary cause of RLS:
- History of initial unresponsiveness to dopaminergic RLS treatment despite adequate dose of initial therapy
- Use of another MAO inhibitor within 30 days of baseline visit
- Allergy or adverse reaction to rasagiline
- Prior adverse reaction to tyramine-containing foods
- Use of meperidine or other opiates within 30 days of the baseline visit
- Use of benzodiazepines within 30 days of the baseline visit
- Use of antidepressants, including TCAs, SSRIs, and SNRIs, except for those permitted as listed above
- Use of other drugs or supplements contraindicated with rasagiline, including St. John's wort, mirtazapine, cyclobenzaprine, dextromethorphan, cold products that contain ephedrine, pseudoephedrine
- Scheduled to undergo elective surgery during the course of the study
- Active medical or psychiatric illness that requires changes to treatment during the course of the study or jeopardize the subject's ability to remain in the study
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01192503
Start Date
September 1 2010
End Date
August 1 2012
Last Update
February 11 2013
Active Locations (8)
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1
Advent Research
Pinellas Park, Florida, United States, 33781
2
Medical College of Georgia Movements Disorders Program
Augusta, Georgia, United States, 30912
3
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, United States, 60611
4
Atlantic Neuroscience Institute Overlook Hospital
Summit, New Jersey, United States, 07902