Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Study Overview
=================
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 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.

Official Title
-----------------
Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: rasagiline
* Drug: placebo (sugar pill)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rasagiline<br> | Drug: rasagiline<br>* 1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks<br>* Other names: Azilect;|
| Placebo Comparator: placebo (sugar pill)<br> | Drug: placebo (sugar pill)<br>* 1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12 | The IRLS is a 10-question scale that contains questions about both the frequency and severity of RLS symptoms, as well as secondary aspects such as sleep quality and daytime tiredness. | Screening, Baseline, Week 6, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability (ability to complete study on assigned dosage) |  | 12 weeks | 
| Adverse events |  | 12 weeks | 
| Change in Beck Depression Inventory from Baseline to Week 12 |  | Baseline, Week 6, Week 12 | 
| Change in Clinical Global Impression - Change from Baseline to Weeks 12 |  | Baseline, Week 6, Week 12 | 
| Change in Medical Outcome Study Sleep Scale from Baseline to Week 12 |  | Baseline, Week 6, Week 12 | 
| Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12 |  | Baseline, week 6, Week 12 | 
| Change in Epworth Sleepiness Scale from Baseline to Week 12 |  | Baseline, Week 6, Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restless Legs Syndrome, rasagiline, futility