Iron infusions put to the test against stubborn restless legs
NCT ID NCT07822607
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether intravenous ferric carboxymaltose, an iron replacement, eases severe restless legs syndrome that has not responded to standard drugs. The trial enrolls 66 adults with drug-resistant RLS and assigns them to receive the infusion either right away or after three months. Participants complete questionnaires, blood draws, and sleep studies over six months to track symptom severity and leg movements during sleep.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intravenous ferric carboxymaltose, an iron replacement given by infusion
- What this could lead to
- If it works, intravenous iron could become a treatment option for people whose restless legs syndrome does not respond to standard drugs.
- What could go wrong
- This is a mid-stage trial with 66 participants, so results may not hold in larger groups. Iron infusions can cause allergic reactions, and the delayed-start design means some participants wait three months before treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Oct 2026
An estimate. Start dates often move.
- Expected to finish
-
Oct 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years; * Weight ≥ 50 kg; * Drug-resistant RLS; * Severe to very severe RLS (IRLSSG-Q score \> 20), persistent or recurrent for more than one month; * Treatment with dopamine agonists without exceeding the recommended doses (ropinirole ≤ 2 mg/day, pramipexole ≤ 0.54 mg/day, rotigotine ≤ 3 mg/day); * Treatment with dopamine agonists and/or α2δ ligands and/or opioids that has been stable for at least 3 months; * In cases of sleep apnea syndrome, treatment with continuous positive airway pressure (CPAP); * Participants were required to be fluent in spoken and written French, be enrolled in a health insurance plan, agree to the automated processing of anonymized confidential data, and have provided written, informed consent for the study. Exclusion Criteria: * Iron supplementation (oral or intravenous) within 3 months prior to enrollment and throughout the study period * Serum ferritin \< 50 µg/L or \> 300 µg/L; * Transferrin saturation \< 20% or \> 45%; * Hemochromatosis; * RLS augmentation syndrome ; * Treatment with neuroleptics or antidepressants; * Allergy to iron; * Severe infectious or inflammatory disease within the past 3 months; * RLS associated with chronic kidney disease, pregnancy, or a clinically significant neurological or psychiatric disorder; * Severe sleep apnea syndrome (AHI \> 30/h) that is untreated, or in cases where treatment is refused or has failed; * Known allergy, inflammatory, or immune disorder; * History of severe asthma, eczema, or any other atopic allergy; * Pregnancy or breastfeeding; * Also excluded are patients participating in another research study, those deprived of their liberty by judicial or administrative order, those living in a medical facility, those subject to a legal protection order, or those from whom consent could not be obtained.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Restless legs syndrome (RLS) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
CHU de Montpellier
Montpellier, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.