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.
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;
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;
Parallel
Ferric Carboxymaltose Injection [Ferinject]
Drugadministration of 1 g of CMF for 2 hours under medical monitoring
Ferric Carboxymaltose Injection [Ferinject]
DrugAdministration of 1 g of CMF for 2 hours under medical monitoring
Randomization
Other interventionRandomization in the arm "Immediate treatment" or "Delayed-onset treatment"
Questionnaire and Physical Exam
Other interventionCompletion 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
Procedure/SurgeryLumbar puncture performed according to standard practice
urine pregnancy test
Procedure/SurgeryDuring 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
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.
Total sleep time
Total sleep time measured in minutes during polysomnography.
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.
Sleep time at stage 1-2 during polysomnography
Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography
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