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

Primary Purpose

Restless Legs Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rasagiline
placebo (sugar pill)
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Restless Legs Syndrome, rasagiline, futility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advent Research
  • Medical College of Georgia Movements Disorders Program
  • Northwestern University PD and Movement Disorders Center
  • Atlantic Neuroscience Institute Overlook Hospital
  • SUNY- Buffalo Jacobs Neurological Institute
  • Cleveland Clinic Sleep Disorders Center
  • University of Pennsylvania Sleep Center
  • Charlottesville Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

rasagiline

placebo (sugar pill)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2010
Last Updated
February 8, 2013
Sponsor
University of Virginia
Collaborators
Teva Neuroscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01192503
Brief Title
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
Acronym
RAS-RLS
Official Title
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Teva Neuroscience, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
Restless Legs Syndrome, rasagiline, futility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rasagiline
Arm Type
Active Comparator
Arm Title
placebo (sugar pill)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rasagiline
Other Intervention Name(s)
Azilect
Intervention Description
1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo (sugar pill)
Intervention Description
1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks
Primary Outcome Measure Information:
Title
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12
Description
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.
Time Frame
Screening, Baseline, Week 6, Week 12
Secondary Outcome Measure Information:
Title
Tolerability (ability to complete study on assigned dosage)
Time Frame
12 weeks
Title
Adverse events
Time Frame
12 weeks
Title
Change in Beck Depression Inventory from Baseline to Week 12
Time Frame
Baseline, Week 6, Week 12
Title
Change in Clinical Global Impression - Change from Baseline to Weeks 12
Time Frame
Baseline, Week 6, Week 12
Title
Change in Medical Outcome Study Sleep Scale from Baseline to Week 12
Time Frame
Baseline, Week 6, Week 12
Title
Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12
Time Frame
Baseline, week 6, Week 12
Title
Change in Epworth Sleepiness Scale from Baseline to Week 12
Time Frame
Baseline, Week 6, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffini S Voss, MD
Organizational Affiliation
University of Virginia, Department of Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernad Ravina, MD. MSCE
Organizational Affiliation
University of Rochester, Movement and Inherited Neurological Disorders Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advent Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Medical College of Georgia Movements Disorders Program
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University PD and Movement Disorders Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Atlantic Neuroscience Institute Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Facility Name
SUNY- Buffalo Jacobs Neurological Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Cleveland Clinic Sleep Disorders Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Sleep Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy of Rasagiline in Restless Legs Syndrome

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