Restless Legs Syndrome Trial, Recruiting NCT02929732 Sponsor: University Hospital, Montpellier Condition: Restless Legs Syndrome
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Restless Legs Syndrome Trial, Recruiting

NCT02929732
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are aged 18 or older but under 75 years old
  • You speak French
  • You are able to understand what the study involves
  • You are willing to sign a consent form agreeing to take part
  • You are registered with French social security
  • (For patients with Restless Legs Syndrome only) You have been diagnosed with Restless Legs Syndrome (RLS) meeting the official 2012 diagnostic criteria set by the International RLS Study Group
  • (For patients with RLS only) Your RLS symptoms are rated as moderate to severe, based on a standard scoring scale (score of 15 or above)
  • (For patients with RLS only) Your blood ferritin (an iron-related protein) level is above 50 ng/ml
  • (For patients with RLS only) You have more than 10 episodes per hour of involuntary leg movements during sleep, measured by a sleep test
  • (For patients with RLS only) Your RLS has no known underlying cause, you have had symptoms for at least 3 years occurring at least 3 times a week, and you have not taken certain RLS medications (dopaminergic agonists, pregabalin, or gabapentin) in the last 8 days

Who may not be able to join:

  • You are legally protected or have restricted freedom (for example, under guardianship or trusteeship), or you are pregnant or breastfeeding
  • You are currently in an exclusion period following participation in another research study
  • You have been treated for cancer in the last 12 months
  • You have a history of heart or blood vessel problems, including heart disease, heart failure, stroke, high blood pressure, or sleep apnea
  • You currently take antidepressants, antipsychotics, or certain other medications affecting the nervous or cardiovascular system, or you take dopamine agonists or opiates (confirm with trial site)
  • (For patients with RLS only) Your RLS is caused by another condition such as kidney failure, iron overload disorder (hemochromatosis), a neurological disorder, or is a side effect of medication
  • (For healthy volunteers/controls only) You have Restless Legs Syndrome (Willis-Ekbom Disease)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
21 March 2017
Est. completion
5 October 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Cardiac sympathetic activity measurement by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy. Analysis of 123I-MIBG uptake based on the ratio heart/mediastinum

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov