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:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT01668667
Eligibility Criteria:
Inclusion Criteria:
* Men or women 18 years of age or older
* History of RLS symptoms for at least 15 nights/month
* Documented RLS symptoms, using the 7-day RLS Symptom Record, for at least 4 of the 7 consecutive evenings/nights during the night
* Total RLS severity score of 15 or greater on the International RLS (IRLS) Rating Scale at Visit 1 and at Visit 2
* Discontinuation of dopamine agonists and/or gabapentin , or other treatments for RLS (e.g. opioids, benzodiazepines) at least 2 weeks prior to Baseline
* If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study
* Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use a highly effective method for avoiding pregnancy
* Body mass index of 34 or below
* Estimated creatinine clearance of ≥60 mL/min
* Provides written consent in accordance with all applicable regulatory requirements
Exclusion Criteria:
* History of a sleep disorder that may affect the assessment of RLS
* History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
* Neurologic disease or movement disorder
* Other medical conditions or drug therapy that could affect RLS efficacy assessments or may present a safety concern
* Have clinically significant or unstable medical conditions
* Have active suicidal plan/intent or has had active suicidal thoughts in the past 6 months; has a history of suicide attempt
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01668667
Study Brief:
Protocol Section:
NCT01668667