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NOT YET RECRUITING
NCT07822607
PHASE2

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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

Interventions

DRUG

Ferric Carboxymaltose Injection [Ferinject]

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

DRUG

Ferric Carboxymaltose Injection [Ferinject]

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

OTHER

Randomization

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

OTHER

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)

PROCEDURE

lumbar puncture

Lumbar puncture performed according to standard practice

PROCEDURE

urine pregnancy test

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

Locations (1)

CHU de Montpellier

Montpellier, France