Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT01192503
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01192503
Study Brief:
Protocol Section:
NCT01192503