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

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.

Study Overview

• Status: Terminated
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Drug: rasagiline; Drug: placebo (sugar pill)

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
• Enrollment (Actual): 52
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Pinellas Park, Florida, United States, 33781
      • Advent Research
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia Movements Disorders Program
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University PD and Movement Disorders Center
  • New Jersey
    • Summit, New Jersey, United States, 07902
      • Atlantic Neuroscience Institute Overlook Hospital
  • New York
    • Buffalo, New York, United States, 14203
      • SUNY- Buffalo Jacobs Neurological Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Sleep Disorders Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Sleep Center
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rasagiline	Drug: rasagiline; 1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks; Other Names: Azilect
Placebo Comparator: placebo (sugar pill)	Drug: placebo (sugar pill); 1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	12 weeks
Tolerability (ability to complete study on assigned dosage)	12 weeks
Change in Beck Depression Inventory from Baseline to Week 12	Baseline, Week 6, Week 12
Change in Clinical Global Impression - Change from Baseline to Weeks 12	Baseline, Week 6, Week 12
Change in Medical Outcome Study Sleep Scale from Baseline to Week 12	Baseline, Week 6, Week 12
Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12	Baseline, week 6, Week 12
Change in Epworth Sleepiness Scale from Baseline to Week 12	Baseline, Week 6, Week 12

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 8, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Restless Legs Syndrome; rasagiline; futility
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: 14630