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

Sponsor

University of Virginia (Other)

Overall Status

Terminated

CT.gov ID

NCT01192503

Collaborator

Teva Neuroscience, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

6.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: rasagiline Drug: placebo (sugar pill)	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: rasagiline	Drug: rasagiline 1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks Other Names: Azilect
Placebo Comparator: placebo (sugar pill)	Drug: placebo (sugar pill) 1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks

Arm

Intervention/Treatment

Active Comparator: rasagiline

Drug: rasagiline

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

Other Names:

Azilect

Placebo Comparator: placebo (sugar pill)

Drug: placebo (sugar pill)

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

Outcome Measures

Primary Outcome Measures

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

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advent Research	Pinellas Park	Florida	United States	33781
2	Medical College of Georgia Movements Disorders Program	Augusta	Georgia	United States	30912
3	Northwestern University PD and Movement Disorders Center	Chicago	Illinois	United States	60611
4	Atlantic Neuroscience Institute Overlook Hospital	Summit	New Jersey	United States	07902
5	SUNY- Buffalo Jacobs Neurological Institute	Buffalo	New York	United States	14203
6	Cleveland Clinic Sleep Disorders Center	Cleveland	Ohio	United States	44195
7	University of Pennsylvania Sleep Center	Philadelphia	Pennsylvania	United States	19104
8	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911

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