Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI

NCT07822607 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Montpellier

Phase

Phase 2

Started

2026-10

Last updated

2026-09-16

Condition(s) studied

Restless Legs Syndrome (RLS)

Investigational drug(s) / intervention(s)

Ferric Carboxymaltose Injection [Ferinject] →Ferric Carboxymaltose Injection [Ferinject] →RandomizationQuestionnaire and Physical Examlumbar punctureurine pregnancy test

Ferric Carboxymaltose Injection [Ferinject]: administration of 1 g of CMF for 2 hours under medical monitoring

Ferric Carboxymaltose Injection [Ferinject]: Administration of 1 g of CMF for 2 hours under medical monitoring

Randomization: Randomization in the arm "Immediate treatment" or "Delayed-onset treatment"

Questionnaire and Physical Exam: Completion of questionnaires and scales: European Quality of Life 5 Dimensions (EQ-5D), Epworth Sleepiness Scale (ESS), Clinical Global Impression (CGI), Patient Global Impression (PGI), Beck Depression Inventory-II (BDI-II), Augmentation Severity Rating Scale (ASRS), International Restless Legs Study Group Severity Rating Scale (IRLSSG-Q), International Restless Legs Syndrome (IRLS), Insomnia Severity Index (ISI)

lumbar puncture: Lumbar puncture performed according to standard practice

urine pregnancy test: During inclusion visit (Day 0) only for women of childbearing age

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

IRLSSG-Q score — From Day 0 to Week 12
IRLSSG-Q : International Restless Legs Study Group Severity Rating Scale allows for the quantification of the severity of restless legs syndrome

Trial sites (1)

Facility	City	Region	Status
CHU de Montpellier	Montpellier	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07822607 on ClinicalTrials.gov ↗ ← All trials in France