Safety and Efficacy of Rasagiline in Restless Legs Syndrome (RAS-RLS)

University of Virginia

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Restless Legs Syndrome

Treatments

Drug: rasagiline

Drug: placebo (sugar pill)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01192503

14630

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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