Clinical trial NCT01192503: Safety and Efficacy of Rasagiline in Restless Legs Syndrome
Official title: Safety and Efficacy of Rasagiline in Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Restless Legs Syndrome
Keywords: Restless Legs Syndrome
rasagiline
futility
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Teva Neuroscience, Inc.
First posted: 2010-09-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12
timeFrame: Screening, Baseline, Week 6, Week 12
Secondary outcomes:
measure: Tolerability (ability to complete study on assigned dosage)
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Change in Beck Depression Inventory from Baseline to Week 12
timeFrame: Baseline, Week 6, Week 12
measure: Change in Clinical Global Impression - Change from Baseline to Weeks 12
timeFrame: Baseline, Week 6, Week 12
measure: Change in Medical Outcome Study Sleep Scale from Baseline to Week 12
timeFrame: Baseline, Week 6, Week 12
measure: Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12
timeFrame: Baseline, week 6, Week 12
measure: Change in Epworth Sleepiness Scale from Baseline to Week 12
timeFrame: Baseline, Week 6, Week 12
Other outcomes:
Locations:
city: Pinellas Park
country: United States
facility: Advent Research
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia Movements Disorders Program
state: Georgia
city: Chicago
country: United States
facility: Northwestern University PD and Movement Disorders Center
state: Illinois
city: Summit
country: United States
facility: Atlantic Neuroscience Institute Overlook Hospital
state: New Jersey
city: Buffalo
country: United States
facility: SUNY- Buffalo Jacobs Neurological Institute
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Sleep Disorders Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Sleep Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
Study officials:
affiliation: University of Virginia, Department of Neurology
name: Tiffini S Voss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester, Movement and Inherited Neurological Disorders Unit
name: Bernad Ravina, MD. MSCE
role: PRINCIPAL_INVESTIGATOR
References: