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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT02929732
Eligibility Criteria:
Inclusion Criteria:
* Non-specific inclusion criteria (CASE + CONTROL)
* 18 years-old or more, and less than 75 years-old
* French-speaking
* able to understand the study
* signed written informed consent
* affiliated to social security
* CASE-specific inclusion criteria
* 5 " International RLS Study Group (IRLSSG) 2012 " positive criteria
* RLS severity scale (IRLS) score ≥ 15
* ferritin \> 50 ng/ml
* periodic limb movements index \> 10/hour
* idiopathic (or primary) Willis-Ekbom disease not treated with dopaminergic agonists or pregabalin or gabapentin in the last 8 days, at least 3 years of disease duration with symptoms recurring at least 3 times a week
Exclusion Criteria:
* Non-specific exclusion criteria (CASE + CONTROL)
* vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship), pregnant or breastfeeding woman
* exclusion period after other research protocol
* malignant neoplastic disease treated in the last 12 months
* medical history of cardiovascular disease (ischemic heart disease, heart failure, stroke, hypertension, sleep apnea syndrome)
* antidepressant, neuroleptic, sympathomimetic, sympatholytic, vasculotropic, dopamine agonists, opiate treatments
* CASE-specific exclusion criteria
\- restless legs syndrome secondary to renal failure, hemochromatosis, neurologic disorders, iatrogenesis
* CONTROL-specific exclusion criteria - Willis-Ekbom Disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT02929732
Study Brief:
Protocol Section:
NCT02929732