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

Name: Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI — clinical trial record (NCT07822607)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: IRON-RLS

StatusNot Yet Recruiting

PhasePhase 2

SponsorUniversity Hospital, Montpellier

Started2026-10

View on ClinicalTrials.gov ↗

University Hospital, Montpellier

303 trials monitored

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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.

Trial Details

NCT Number	NCT07822607
Lead Sponsor	University Hospital, Montpellier
Conditions	Restless Legs Syndrome (RLS)
Enrollment	66 participants
Start Date	2026-10
Primary Completion	2029-04 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2026-09-16