Safety and Efficacy of Rasagiline in Restless Legs Syndrome

NCT ID: NCT01192503

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-08-31

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.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

rasagiline

Group Type: ACTIVE_COMPARATOR

rasagiline

Intervention Type: DRUG

1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks

placebo (sugar pill)

Group Type: PLACEBO_COMPARATOR

placebo (sugar pill)

Intervention Type: DRUG

1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks

Interventions

rasagiline

1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks

Intervention Type: DRUG

placebo (sugar pill)

1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Azilect

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Neuroscience, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Colleen P Harman

Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiffini S Voss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia, Department of Neurology

Bernad Ravina, MD. MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Rochester, Movement and Inherited Neurological Disorders Unit

Locations

Advent Research

Pinellas Park, Florida, United States

Medical College of Georgia Movements Disorders Program

Augusta, Georgia, United States

Northwestern University PD and Movement Disorders Center

Chicago, Illinois, United States

Atlantic Neuroscience Institute Overlook Hospital

Summit, New Jersey, United States

SUNY- Buffalo Jacobs Neurological Institute

Buffalo, New York, United States

Cleveland Clinic Sleep Disorders Center

Cleveland, Ohio, United States

University of Pennsylvania Sleep Center

Philadelphia, Pennsylvania, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

14630

Identifier Type: -

Identifier Source: org_study_id