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Iron infusions put to the test against stubborn restless legs

NCT ID NCT07822607

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • CHU de Montpellier

    Montpellier, France

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