Safety and Efficacy of Rasagiline in Restless Legs Syndrome - Full Text View

Purpose

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	Intervention	Phase
Restless Legs Syndrome	Drug: rasagiline Drug: placebo (sugar pill)	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs

Drug Information available for: Rasagiline mesylate

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

Tolerability (ability to complete study on assigned dosage) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Change in Beck Depression Inventory from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]
Change in Clinical Global Impression - Change from Baseline to Weeks 12 [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]
Change in Medical Outcome Study Sleep Scale from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]
Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12 [ Time Frame: Baseline, week 6, Week 12 ] [ Designated as safety issue: No ]
Change in Epworth Sleepiness Scale from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	September 2010
Study Completion Date:	August 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192503

Locations

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.

Investigators

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

More Information

No publications provided

Responsible Party:	Colleen P Harman, Project Manager, University of Virginia
ClinicalTrials.gov Identifier:	NCT01192503 History of Changes
Other Study ID Numbers:	14630
Study First Received:	August 23, 2010
Last Updated:	February 8, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Virginia:

Restless Legs Syndrome
rasagiline
futility

Additional relevant MeSH terms:

Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations

Signs and Symptoms
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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