BridgeMD
New treatment option for Willis-Ekbom Disease
Official title Analysis of Sympathetic Activity in Willis-Ekbom Disease
ClinicalTrials.gov ID: NCT02929732
What this study is testing
- What it's testing
- Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common neurological sensorimotor disorder that typically impairs sleep and quality of life, likely consequent to a central dopaminergic dysfunction associated to brain iron deficiency. Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74. Healthy volunteers may be eligible.
You may be able to join if
- Non-specific (CASE + CONTROL)
- 18 years-old or more, and less than 75 years-old
- French-speaking
- able to understand the study
- signed written informed consent
You likely can't join if
- 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
See the full eligibility criteria
- Non-specific (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 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.