Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Key facts
- Where
- Montpellier Cedex 5, FranceSee the site
- Phase
- Phase 2
Where in France
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Montpellier
- Trial code
- NCT07822607EU 2026-525613-31-00
- Record updated
- 16 September 2026
- Original description
The pathophysiology of restless legs syndrome (RLS) is not well understood: it is thought to involve intracerebral iron deficiency and dopaminergic dysregulation.Read full original descriptionShow less
Intravenous Iron in the Management of Drug-resistant Restless Legs Syndrome: a Randomized Controlled Delayed-start Trial. IRON-RLS
The pathophysiology of restless legs syndrome (RLS) is not well understood: it is thought to involve intracerebral iron deficiency and dopaminergic dysregulation.
This study aims to evaluate the use of intravenous ferric carboxymaltose in patients with restless legs syndrome (RLS).
This study plans to include individuals with RLS, who will be divided into two groups:
* One group will receive intravenous iron immediately after the baseline polysomnography * The second group will receive intravenous iron 3 months after randomization. In total, participants will be followed for 6 months, during which time they will be required to complete questionnaires regularly, undergo blood draws, and have two polysomnography tests.
Inclusion: 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: Iron supplementation (oral or intravenous) within 3 months prior to enrollment and throughout the study period; Treatment with neuroleptics or antidepressants; RLS augmentation syndrome ; 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; Serum ferritin < 50 µg/L or > 300 µg/L; Transferrin saturation < 20% or > 45%; Hemochromatosis; 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.