Restless Legs Syndrome Clinical Trial
— RAS-RLSOfficial title:
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
Verified date | February 2013 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 52 |
Est. completion date | August 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Georgia Movements Disorders Program | Augusta | Georgia |
United States | SUNY- Buffalo Jacobs Neurological Institute | Buffalo | New York |
United States | Charlottesville Medical Research | Charlottesville | Virginia |
United States | Northwestern University PD and Movement Disorders Center | Chicago | Illinois |
United States | Cleveland Clinic Sleep Disorders Center | Cleveland | Ohio |
United States | University of Pennsylvania Sleep Center | Philadelphia | Pennsylvania |
United States | Advent Research | Pinellas Park | Florida |
United States | Atlantic Neuroscience Institute Overlook Hospital | Summit | New Jersey |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | Teva Neuroscience, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Tolerability (ability to complete study on assigned dosage) | 12 weeks | Yes | |
Secondary | Adverse events | 12 weeks | Yes | |
Secondary | Change in Beck Depression Inventory from Baseline to Week 12 | Baseline, Week 6, Week 12 | No | |
Secondary | Change in Clinical Global Impression - Change from Baseline to Weeks 12 | Baseline, Week 6, Week 12 | No | |
Secondary | Change in Medical Outcome Study Sleep Scale from Baseline to Week 12 | Baseline, Week 6, Week 12 | No | |
Secondary | Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12 | Baseline, week 6, Week 12 | No | |
Secondary | Change in Epworth Sleepiness Scale from Baseline to Week 12 | Baseline, Week 6, Week 12 | No |
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