NCT07822607

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
49mo left

Started Oct 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

2.5 years

First QC Date

August 28, 2026

Last Update Submit

September 11, 2026

Conditions

Restless Legs Syndrome (RLS)

Keywords

Ferric carboxymaltoseperiodic legs movementsintractable restless legs

Outcome Measures

Primary Outcomes (1)

  • IRLSSG-Q score

    IRLSSG-Q : International Restless Legs Study Group Severity Rating Scale allows for the quantification of the severity of restless legs syndrome

    From Day 0 to Week 12

Secondary Outcomes (18)

  • Periodic Limb Movements during Sleep (PLMS) index

    From V1 (Day 0) to V5 (week 24)

  • Total sleep time

    From day 0 to week 24

  • Sleep latency

    From Day 0 to week 24

  • Sleep time at stage 1-2 during polysomnography

    From Day 0 to week 24

  • Sleep time at stage 3 during polysomnography

    From Day 0 to week 24

  • +13 more secondary outcomes

Study Arms (2)

Immediate treatment

EXPERIMENTAL

The treatment will be administered at at baseline (V1), immediately after the baseline polysomnography

Drug: Ferric Carboxymaltose Injection [Ferinject]Other: RandomizationOther: Questionnaire and Physical ExamProcedure: lumbar punctureProcedure: urine pregnancy test

Delayed-onset treatment

ACTIVE COMPARATOR

The treatment will be administered at 12 weeks

Drug: Ferric Carboxymaltose Injection [Ferinject]Other: RandomizationOther: Questionnaire and Physical ExamProcedure: lumbar punctureProcedure: urine pregnancy test

Interventions

Ferric Carboxymaltose Injection [Ferinject]DRUG

administration of 1 g of CMF for 2 hours under medical monitoring

Immediate treatment
RandomizationOTHER

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

Delayed-onset treatmentImmediate treatment
Questionnaire and Physical ExamOTHER

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)

Delayed-onset treatmentImmediate treatment
lumbar puncturePROCEDURE

Lumbar puncture performed according to standard practice

Delayed-onset treatmentImmediate treatment
urine pregnancy testPROCEDURE

During inclusion visit (Day 0) only for women of childbearing age

Delayed-onset treatmentImmediate treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

ferric carboxymaltoseRandom AllocationSurveys and QuestionnairesRestraint, PhysicalSpinal Puncture

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthData CollectionBehavior ControlTherapeuticsImmobilizationBiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesSurgical Procedures, Operative

Central Study Contacts

Yves DAUVILLIERS, MD - PhD

CONTACT

0033 467 3374 78y-dauvilliers@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 16, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

October 1, 2030

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)