Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Restless Legs Syndrome Clinical Trial

— RAS-RLS  

Official title:

Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01192503
• Other study ID #: 14630
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 23, 2010
• Last updated: February 8, 2013
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• rasagiline
1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks
• placebo (sugar pill)
1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks

Locations

Country	Name	City	State
United States	Medical College of Georgia Movements Disorders Program	Augusta	Georgia
United States	SUNY- Buffalo Jacobs Neurological Institute	Buffalo	New York
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Northwestern University PD and Movement Disorders Center	Chicago	Illinois
United States	Cleveland Clinic Sleep Disorders Center	Cleveland	Ohio
United States	University of Pennsylvania Sleep Center	Philadelphia	Pennsylvania
United States	Advent Research	Pinellas Park	Florida
United States	Atlantic Neuroscience Institute Overlook Hospital	Summit	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Teva Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Tolerability (ability to complete study on assigned dosage)		12 weeks	Yes
Secondary	Adverse events		12 weeks	Yes
Secondary	Change in Beck Depression Inventory from Baseline to Week 12		Baseline, Week 6, Week 12	No
Secondary	Change in Clinical Global Impression - Change from Baseline to Weeks 12		Baseline, Week 6, Week 12	No
Secondary	Change in Medical Outcome Study Sleep Scale from Baseline to Week 12		Baseline, Week 6, Week 12	No
Secondary	Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12		Baseline, week 6, Week 12	No
Secondary	Change in Epworth Sleepiness Scale from Baseline to Week 12		Baseline, Week 6, Week 12	No