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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01192503
Recruitment Status : Terminated (Slow enrollment)
First Posted : September 1, 2010
Last Update Posted : February 11, 2013
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Colleen P Harman, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: rasagiline Drug: placebo (sugar pill) Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Rasagiline in Restless Legs Syndrome
Study Start Date : September 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Arm Intervention/treatment
Active Comparator: rasagiline Drug: rasagiline
1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks
Other Name: Azilect

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

Primary Outcome Measures :
  1. Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12 [ Time Frame: Screening, Baseline, Week 6, 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.

Secondary Outcome Measures :
  1. Tolerability (ability to complete study on assigned dosage) [ Time Frame: 12 weeks ]
  2. Adverse events [ Time Frame: 12 weeks ]
  3. Change in Beck Depression Inventory from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ]
  4. Change in Clinical Global Impression - Change from Baseline to Weeks 12 [ Time Frame: Baseline, Week 6, Week 12 ]
  5. Change in Medical Outcome Study Sleep Scale from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ]
  6. Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12 [ Time Frame: Baseline, week 6, Week 12 ]
  7. Change in Epworth Sleepiness Scale from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01192503

United States, Florida
Advent Research
Pinellas Park, Florida, United States, 33781
United States, Georgia
Medical College of Georgia Movements Disorders Program
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, United States, 60611
United States, New Jersey
Atlantic Neuroscience Institute Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New York
SUNY- Buffalo Jacobs Neurological Institute
Buffalo, New York, United States, 14203
United States, Ohio
Cleveland Clinic Sleep Disorders Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Sleep Center
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
University of Virginia
Teva Neuroscience, Inc.
Principal Investigator: Tiffini S Voss, MD University of Virginia, Department of Neurology
Principal Investigator: Bernad Ravina, MD. MSCE University of Rochester, Movement and Inherited Neurological Disorders Unit

Responsible Party: Colleen P Harman, Project Manager, University of Virginia Identifier: NCT01192503     History of Changes
Other Study ID Numbers: 14630
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Colleen P Harman, University of Virginia:
Restless Legs Syndrome

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs