Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Launched by UNIVERSITY OF VIRGINIA · Aug 31, 2010

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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