Safety and Efficacy of Rasagiline in Restless Legs Syndrome

NCT01192503 | Terminated Phase 2

• 1 other identifier: 14630
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 8

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.

Conditions

Restless Legs Syndrome

Keywords

Restless Legs Syndrome; rasagiline; futility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Tolerability (ability to complete study on assigned dosage)

  12 weeks

• Adverse events

  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

Study Arms (2)

rasagiline

ACTIVE COMPARATOR

Drug: rasagiline

placebo (sugar pill)

PLACEBO COMPARATOR

Drug: placebo (sugar pill)

Interventions

rasagiline DRUG

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

Also known as: Azilect

rasagiline

placebo (sugar pill) DRUG

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

placebo (sugar pill)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• Teva Neuroscience, Inc.: collaborator

Study Sites (8)

Advent Research

Pinellas Park, Florida, 33781, United States

Location

Medical College of Georgia Movements Disorders Program

Augusta, Georgia, 30912, United States

Location

Northwestern University PD and Movement Disorders Center

Chicago, Illinois, 60611, United States

Location

Atlantic Neuroscience Institute Overlook Hospital

Summit, New Jersey, 07902, United States

Location

SUNY- Buffalo Jacobs Neurological Institute

Buffalo, New York, 14203, United States

Location

Cleveland Clinic Sleep Disorders Center

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Sleep Center

Philadelphia, Pennsylvania, 19104, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

rasagiline; Sugars

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: September 1, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

US (8)