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Intravenous iron in the management of drug-resistant restless legs syndrome
EU CTIS ID: 2026-525613-31-00
What this study is testing
To evaluate the efficacy of intravenous ferric carboxymaltose (FCM) 1000 mg administered according to AASM guidelines, compared with conventional management according to SFRMS recommendations, on the change in IRLSSG-Q score between the baseline visit (V1) and the 3-month follow-up visit (V3), in patients with pharmacoresistant restless legs syndrome (RLS).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Be affiliated with a health insurance system
- Written informed consent for participation in the study
- Body weight ≥ 50 kg
- Pharmacoresistant restless legs syndrome (RLS)
- Severe to very severe RLS (IRLSSG-Q score >20), persistent or recurrent for more than one month
You likely can't join if
- Iron supplementation (oral or intravenous) within the 6 months prior to inclusion and throughout the study period
- Severe obstructive sleep apnea (apnea–hypopnea index >30/h) that is untreated, or in cases of refusal or failure of treatment
- Known allergy, inflammatory or immune disorder
- History of severe asthma, eczema, or any other atopic disease
- Pregnancy or breastfeeding
- Ongoing participation in a clinical study
See the full eligibility criteria
- Age ≥ 18 years
- Be affiliated with a health insurance system
- Written informed consent for participation in the study
- Body weight ≥ 50 kg
- Pharmacoresistant restless legs syndrome (RLS)
- Severe to very severe RLS (IRLSSG-Q score >20), persistent or recurrent for more than one month
- Treatment with dopamine agonists without exceeding recommended doses (ropinirole ≤ 2 mg/day, pramipexole ≤ 0.54 mg/day, rotigotine ≤ 3 mg/day)
- Stable treatment with dopamine agonists and/or α2δ ligands and/or opioids for at least 3 months
- In the presence of sleep apnea syndrome, treatment with continuous positive airway pressure (CPAP)
- Fluent in spoken and written French
- Agree to the automated processing of anonymized confidential data
- Iron supplementation (oral or intravenous) within the 6 months prior to inclusion and throughout the study period
- Severe obstructive sleep apnea (apnea–hypopnea index >30/h) that is untreated, or in cases of refusal or failure of treatment
- Known allergy, inflammatory or immune disorder
- History of severe asthma, eczema, or any other atopic disease
- Pregnancy or breastfeeding
- Ongoing participation in a clinical study
- Deprived of liberty by judicial or administrative decision
- Living in a medicalized institution
- Under legal protection
- Failure to obtain consent
- Serum ferritin <50 µg/L or >300 µg/L
- Transferrin saturation coefficient <20% or >45%
- Hemochromatosis
- Augmentation syndrome in RLS
- Treatment with antipsychotics or antidepressants
- Known iron allergy
- Severe infectious or inflammatory disease within the previous 3 months
- RLS associated with chronic kidney disease, pregnancy, or a clinically significant neurological or psychiatric disorder
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.