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Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Sponsor: University Hospital, Montpellier
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.
Official title: Intravenous Iron in the Management of Drug-resistant Restless Legs Syndrome: a Randomized Controlled Delayed-start Trial. IRON-RLS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-10
Completion Date
2030-10
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
CHU de Montpellier
Montpellier, France