Safety and Efficacy of Rasagiline in Restless Legs Syndrome

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: Teva Neuroscience, Inc.
• Treatments: Rasagiline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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