A Phase 2 interventional study of Ferric Carboxymaltose Injection [Ferinject] and Ferric Carboxymaltose Injection [Ferinject] in Restless Legs Syndrome (RLS), sponsored by University Hospital, Montpellier. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University Hospital, Montpellier · Phase 2, Interventional, and Treatment
Among 17 studies in Restless Legs Syndrome with a site in France — 7 open to participants now, 7 under way, none of them phase 3. Restless Legs Syndrome · France.
Among the 17 studies in Restless Legs Syndrome with a site in France, this one is the 5th largest by planned enrollment of the 13 interventional ones, is the only one that started in 2026, is one of 3 in phase 2, and was the 17th registered.
259 studies on the registry are indexed under Restless Legs Syndrome; 38 are open to participants now.
This study's planned enrollment of 66 is above the median of 53 across 200 interventional studies indexed under Restless Legs Syndrome.
Browse Restless Legs Syndrome studies →7 of the 17 studies in Restless Legs Syndrome with a site in France are open now, in 1 country. Each count lists the studies.
Of the 25 Restless Legs Syndrome studies recruiting now, 10 (40%) set no upper age limit and 12 (48%) stop at 75 or younger; 0 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2026.
Median enrollment 55 across the 13 interventional studies, 410 across the 4 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
4 of 17 have an industry lead sponsor. The 8 most frequent:
University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
University Hospital, Montpellier has 7 studies filed under Restless Legs Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Restless Legs Syndrome with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05695963University Hospital, BordeauxEcological Momentary Assessment in Patients With Restless Legs Syndrome | 2027-01 |
| NCT02929732University Hospital, MontpellierAnalysis of Sympathetic Activity in Willis-Ekbom Disease | 2027-10-05 |
Among the 17 studies in Restless Legs Syndrome with a site in France, from their registry updates:
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment will be administered at at baseline (V1), immediately after the baseline polysomnography
Drug: Ferric Carboxymaltose Injection [Ferinject] · Other: Randomization · Other: Questionnaire and Physical Exam · Procedure: lumbar puncture · Procedure: urine pregnancy test
The treatment will be administered at 12 weeks
Drug: Ferric Carboxymaltose Injection [Ferinject] · Other: Randomization · Other: Questionnaire and Physical Exam · Procedure: lumbar puncture · Procedure: urine pregnancy test
administration of 1 g of CMF for 2 hours under medical monitoring
Administration of 1 g of CMF for 2 hours under medical monitoring
Randomization in the arm "Immediate treatment" or "Delayed-onset treatment"
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 performed according to standard practice
During inclusion visit (Day 0) only for women of childbearing age
IRLSSG-Q score
IRLSSG-Q : International Restless Legs Study Group Severity Rating Scale allows for the quantification of the severity of restless legs syndrome
Time frame: From Day 0 to Week 12
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.
Time frame: From V1 (Day 0) to V5 (week 24)
Total sleep time
Total sleep time measured in minutes during polysomnography.
Time frame: From day 0 to week 24
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.
Time frame: From Day 0 to week 24
Sleep time at stage 1-2 during polysomnography
Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography
Time frame: From Day 0 to week 24
Sleep time at stage 3 during polysomnography
Time spent in stage 3 sleep measured in hours and minutes during polysomnography
Time frame: From Day 0 to week 24
Micro-awakenings index (MAI)
The Micro-awakenings index measures the number of brief awakenings that the person does not notice per hour of sleep.
Time frame: From Day 0 to week 24
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.
Time frame: From Day 0 to week 24
Average arterial oxygen saturation (SaO2)
The unit of measurement for SaO2 is the percentage (%).
Time frame: From Day 0 to Week 24
Oxygen desaturation index (IDO)
The oxygen desaturation index (IDO) measures the number of significant drops in blood oxygen levels per hour of sleep.
Time frame: From Day 0 to week 24
Serum ferritin
Time frame: From Day 0 to week 24
Transferrin saturation coefficient
Time frame: From Day 0 to Week 24
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
Time frame: From Day 0 to Week 24
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
Time frame: From Day 0 to Week 24
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
Time frame: From Day 0 to Week 24
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
Time frame: From Day 0 to Week 24
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)
Time frame: From Day 0 to Week 24
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
Time frame: From Day 0 to Week 24
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
Time frame: From Day 0 to week 24
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2029, 30 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferric carboxymaltose
University Hospital, Montpellier →