Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Phase 2

Terminated

• Conditions: Restless Legs Syndrome
• Interventions: Drug: placebo (sugar pill); Drug: rasagiline

• Registration Number: NCT01192503
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-31
• Study Start: 2010-09
• Study First Posted: 2010-09-01
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo (sugar pill)	placebo (sugar pill)	-
rasagiline	rasagiline	-

Primary Outcome Measures

Name	Time	Method
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12	Screening, Baseline, Week 6, 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

Name	Time	Method
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

Trial Locations

Locations (8)

University of Pennsylvania Sleep Center; 🇺🇸 Philadelphia, Pennsylvania, United States

SUNY- Buffalo Jacobs Neurological Institute; 🇺🇸 Buffalo, New York, United States

Medical College of Georgia Movements Disorders Program; 🇺🇸 Augusta, Georgia, United States

Advent Research; 🇺🇸 Pinellas Park, Florida, United States

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States

Northwestern University PD and Movement Disorders Center; 🇺🇸 Chicago, Illinois, United States

Atlantic Neuroscience Institute Overlook Hospital; 🇺🇸 Summit, New Jersey, United States

Cleveland Clinic Sleep Disorders Center; 🇺🇸 Cleveland, Ohio, United States