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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01192503
Other study ID # 14630
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received August 23, 2010
Last updated February 8, 2013
Start date September 2010
Est. completion date August 2012

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
rasagiline
1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks
placebo (sugar pill)
1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Virginia Teva Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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