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

This study is currently recruiting participants.
Verified May 2011 by University of Virginia
Sponsor:
Collaborator:
Teva Neuroscience, Inc.
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01192503
First received: August 23, 2010
Last updated: May 11, 2011
Last verified: May 2011
History of Changes
  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
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 ]

Estimated Enrollment: 52
Study Start Date: September 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (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

Contacts
Contact: Colleen Harman, RN, CRC 434-924-9664 cph@virginia.edu

Locations
United States, Florida
Advent Research Recruiting
Pinellas Park, Florida, United States, 33781
Contact: Bridget Hester, MA     727-521-9200     brichardson@adventcrc.com    
Contact: Debra Figueroa, MD     727-521-9200     dfigueroa@adventcrc.com    
Principal Investigator: Debra Figueroa, MD            
United States, Georgia
Medical College of Georgia Movements Disorders Program Recruiting
Augusta, Georgia, United States, 30912
Contact: Zachary Martin     706-721-4912     zmartin@georgiahealth.edu    
Contact: Shyamal Mehta, MD     706 721 2798     shmehta@mcg.edu    
Principal Investigator: Shyamal Mehta, MD            
United States, Illinois
Northwestern University PD and Movement Disorders Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Laura Wulf     312-503-1999     l-wulf@northwestern.edu    
Contact: Alekasandar Videnovic, MD     312 503 1819     a-videnovic@northwestern.edu    
Principal Investigator: Aleksandar Videnovic, MD            
United States, New Jersey
Atlantic Neuroscience Institute Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Sandra Wrigley, RN     908-598-7991     sandra.wrigley@atlantichealth.org    
Contact: Roger Kurlan, MD     908 522 2089     roger.kurlan@atlantichealth.org    
Principal Investigator: Roger Kurlan, MD            
United States, New York
SUNY- Buffalo Jacobs Neurological Institute Recruiting
Buffalo, New York, United States, 14203
Contact: Kara Patrick     716-859-7510     kpatrick@kaleidahealth.org    
Contact: David Hojnacki, MD         dhojnacki@kaleidahealth.org    
Principal Investigator: David Hojnacki, MD            
United States, Ohio
Cleveland Clinic Sleep Disorders Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Judith A Meinert, ACSW, LISW, CCRP     216 445 7168     meinerj@ccf.org    
Contact: Nancy Foldvary-Schaefer, MD Site Investigator     216 445 2990     foldvan@ccf.org    
Principal Investigator: Nancy Foldvary-Schaefer, MD            
United States, Pennsylvania
University of Pennsylvania Sleep Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rebecca Lang     215-615-1756     rebecca.lang@uphs.upenn.edu    
Contact: Charles Cantor, MD         crcantor@uphs.upenn.edu    
Principal Investigator: Charles Cantor, MD            
United States, Virginia
Charlottesville Medical Research Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Kathy Stuples, LPN, CCRC     434-817-2442 ext 102     kathy@cvillemedresearch.com    
Contact: Pari Nikpey, MD     434 817 2442     study@cvillemedresearch.com    
Principal Investigator: Pari Nikpey, MD            
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: Tiffini Voss, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01192503     History of Changes
Other Study ID Numbers: 14630
Study First Received: August 23, 2010
Last Updated: May 11, 2011
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 October 17, 2012