Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT01192503

Run by

University of Virginia

People needed

52

Starts

2010-09-01

Expected to finish

2012-08-01

Last updated by the study team

2013-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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