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Restless Legs Syndrome (RLS)Phase 2IRON-RLSNCT07822607

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

A Phase 2 study testing Ferric Carboxymaltose Injection [Ferinject], Randomization and Questionnaire and Physical Exam in people with Restless Legs Syndrome (RLS), run by University Hospital, Montpellier at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Restless Legs Syndrome (RLS)
What is being tested?
Ferric Carboxymaltose Injection [Ferinject], Randomization and Questionnaire and Physical Exam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteFrance
Study dates
Oct 2026to Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yves DAUVILLIERS, MD - PhD contact

0033 467 3374 78

y-dauvilliers@chu-montpellier.fr

France1 site

  • CHU de Montpellier

    Montpellier

    Yves DAUVILLIERS, MD PhD, 033 4 6733 7478, y-dauvilliers@chu-montpellier.fr

Other trials in France

About this study

Official title: 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).

Read more

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.
Being tested
Ferric Carboxymaltose Injection [Ferinject], Randomization, Questionnaire and Physical Exam, lumbar puncture, urine pregnancy test
Keywords
Ferric carboxymaltose, periodic legs movements, intractable restless legs
Medical subject headings
Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric Carboxymaltose Injection [Ferinject]Drug

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

  • Ferric Carboxymaltose Injection [Ferinject]Drug

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

  • RandomizationOther

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

  • lumbar punctureProcedure or surgery

    Lumbar puncture performed according to standard practice

  • urine pregnancy testProcedure or surgery

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

Study groups in NCT07822607
Study groupRoleWhat they receive
Immediate treatmentExperimentalThe treatment will be administered at at baseline (V1), immediately after the baseline polysomnography
Receives: Drug: Ferric Carboxymaltose Injection [Ferinject]; Other: Randomization; Other: Questionnaire and Physical Exam; Procedure: lumbar puncture; Procedure: urine pregnancy test
Delayed-onset treatmentActive comparatorThe treatment will be administered at 12 weeks
Receives: Drug: Ferric Carboxymaltose Injection [Ferinject]; Other: Randomization; Other: Questionnaire and Physical Exam; Procedure: lumbar puncture; Procedure: urine pregnancy test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From Day 0 to Week 12

Secondary outcomes (18)

  1. Periodic Limb Movements during Sleep (PLMS) index

    The PLMS Index measures the average number of involuntary leg movements per hour of sleeping during polysomnography. 15 or more per hour: Considered abnormal for adults and may suggest a condition called Periodic Limb Movement Disorder (PLMD) if it disrupts your sleep.

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

  2. Total sleep time

    Total sleep time measured in minutes during polysomnography.

    Measured: From day 0 to week 24

  3. Sleep latency

    Length of time in minutes it takes to transition from full wakefulness to the lightest stage of sleep after the lights are turned off.

    Measured: From Day 0 to week 24

  4. Sleep time at stage 1-2 during polysomnography

    Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography

    Measured: From Day 0 to week 24

  5. Sleep time at stage 3 during polysomnography

    Time spent in stage 3 sleep measured in hours and minutes during polysomnography

    Measured: From Day 0 to week 24

  6. Micro-awakenings index (MAI)

    The Micro-awakenings index measures the number of brief awakenings that the person does not notice per hour of sleep.

    Measured: From Day 0 to week 24

  7. Apnea-hypopnea index (AHI)

    The apnea-hypopnea index (AHI) measures the average number of interruptions or reductions in breathing per hour of sleep to assess the severity of sleep apnea.

    Measured: From Day 0 to week 24

  8. Average arterial oxygen saturation (SaO2)

    The unit of measurement for SaO2 is the percentage (%).

    Measured: From Day 0 to Week 24

  9. Oxygen desaturation index (IDO)

    The oxygen desaturation index (IDO) measures the number of significant drops in blood oxygen levels per hour of sleep.

    Measured: From Day 0 to week 24

  10. Serum ferritin

    Measured: From Day 0 to week 24

  11. Transferrin saturation coefficient

    Measured: From Day 0 to Week 24

  12. Epworth Sleepiness Scale (ESS)

    A measure of excessive daytime sleepiness that quantifies the impact of the condition on alertness throughout the day. Eight everyday situations are rated (for example, watching television, riding as a passenger in a car, sitting quietly in a public place). Each situation is scored from 0 to 3 based on the likelihood of falling asleep. Total score 0-24; a score of ≥10 suggests excessive sleepiness

    Measured: From Day 0 to Week 24

  13. European Quality of Life 5 Dimensions (EQ-5D)

    EQ-5D: this self-administered questionnaire assesses five dimensions (mobility, daily activities, self-care, pain/discomfort, anxiety/depression) as well as overall health status on a visual scale from 0 to 100

    Measured: From Day 0 to Week 24

  14. Clinical Global Impression (CGI)

    The clinician's overall assessment of the illness, including CGI-S (severity) and CGI-I (change). 7-point scale: CGI-S 1 = normal, 7 = extremely ill; CGI-I 1 = markedly improved, 7 = markedly worsened

    Measured: From Day 0 to Week 24

  15. Patient Global Impression (PGI)

    Patient's overall perception of the severity of their illness or change; a simple 7-point scale, self-reported. A high score is associated with patients perceiving their symptoms as severe

    Measured: From Day 0 to Week 24

  16. Beck Depression Inventory-II (BDI-II)

    BDI-II: a self-administered questionnaire consisting of 21 items that assess the severity of depressive symptoms over the past two weeks; score range: 0-63; thresholds: 0-13 (mild), 14-19 (moderate), 20-28 (severe), ≥29 (severe)

    Measured: From Day 0 to Week 24

  17. Augmentation Severity Rating Scale (ASRS)

    A 7-item self-administered questionnaire used to quantify the severity of the augmentation syndrome in patients treated with dopamine agonists. It assesses the worsening or early onset of RLS symptoms and their impact on sleep and daily activities

    Measured: From Day 0 to Week 24

  18. Insomnia Severity Index (ISI)

    To assess the severity of the patient's insomnia, taking into account both the quantity and quality of sleep, as well as its impact on daily functioning (fatigue, concentration, mood). A 7-item self-report questionnaire scored from 0 to 4, with a total score of 0-28; 0-7 indicates no insomnia, 8-14 mild, 15-21 moderate, and 22-28 severe insomnia

    Measured: From Day 0 to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionApr 2029 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07822607
Sponsor's protocol ID
RECHMPL25_0557
Other IDs
2026-525613-31-00
Acronym
IRON-RLS
Status last verified
Sep 2026
First submitted
28 Aug 2026
Last updated
16 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ferric Carboxymaltose Injection [Ferinject], Randomization and Questionnaire and Physical Exam in people with Restless Legs Syndrome (RLS), run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yves DAUVILLIERS, MD - PhD (0033 467 3374 78, y-dauvilliers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IRLSSG-Q score (time frame: From Day 0 to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07822607.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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