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

Phase 2Not Yet RecruitingNCT07822607

University Hospital, Montpellier66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Restless Legs Syndrome (RLS)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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; * Treatment with dopamine agonists without exceeding the recommended doses (ropinirole ≤ 2 mg/day, pramipexole ≤ 0.54 mg/day, rotigotine ≤ 3 mg/day); * Treatment with dopamine agonists and/or α2δ ligands and/or opioids that has been stable for at least 3 months; * In cases of sleep apnea syndrome, treatment with continuous positive airway pressure (CPAP); * Participants were required to be fluent in spoken and written French, be enrolled in a health insurance plan, agree to the automated processing of anonymized confidential data, and have provided written, informed consent for the study. Exclusion Criteria: * 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; * RLS augmentation syndrome ; * Treatment with neuroleptics or antidepressants; * Allergy to iron; * Severe infectious or inflammatory disease within the past 3 months; * RLS associated with chronic kidney disease, pregnancy, or a clinically significant neurological or psychiatric disorder; * Severe sleep apnea syndrome (AHI \> 30/h) that is untreated, or in cases where treatment is refused or has failed; * Known allergy, inflammatory, or immune disorder; * History of severe asthma, eczema, or any other atopic allergy; * Pregnancy or breastfeeding; * Also excluded are patients participating in another research study, those deprived of their liberty by judicial or administrative order, those living in a medical facility, those subject to a legal protection order, or those from whom consent could not be obtained.

Outcomes

Primary Outcomes

IRLSSG-Q score

IRLSSG-Q : International Restless Legs Study Group Severity Rating Scale allows for the quantification of the severity of restless legs syndrome

Time frame: From Day 0 to Week 12

Secondary Outcomes

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.

Time frame: From V1 (Day 0) to V5 (week 24)

Total sleep time

Total sleep time measured in minutes during polysomnography.

Time frame: From day 0 to week 24

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.

Time frame: From Day 0 to week 24

Sleep time at stage 1-2 during polysomnography

Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography

Time frame: From Day 0 to week 24

Sleep time at stage 3 during polysomnography

Time spent in stage 3 sleep measured in hours and minutes during polysomnography

Time frame: From Day 0 to week 24

Micro-awakenings index (MAI)

The Micro-awakenings index measures the number of brief awakenings that the person does not notice per hour of sleep.

Time frame: From Day 0 to week 24

Apnea-hypopnea index (AHI)

The apnea-hypopnea index (AHI) measures the average number of interruptions or reductions in breathing per hour of sleep to assess the severity of sleep apnea.

Time frame: From Day 0 to week 24

Average arterial oxygen saturation (SaO2)

The unit of measurement for SaO2 is the percentage (%).

Time frame: From Day 0 to Week 24

Oxygen desaturation index (IDO)

The oxygen desaturation index (IDO) measures the number of significant drops in blood oxygen levels per hour of sleep.

Time frame: From Day 0 to week 24

Serum ferritin

Time frame: From Day 0 to week 24

Transferrin saturation coefficient

Time frame: From Day 0 to Week 24

Epworth Sleepiness Scale (ESS)

A measure of excessive daytime sleepiness that quantifies the impact of the condition on alertness throughout the day. Eight everyday situations are rated (for example, watching television, riding as a passenger in a car, sitting quietly in a public place). Each situation is scored from 0 to 3 based on the likelihood of falling asleep. Total score 0-24; a score of ≥10 suggests excessive sleepiness

Time frame: From Day 0 to Week 24

European Quality of Life 5 Dimensions (EQ-5D)

EQ-5D: this self-administered questionnaire assesses five dimensions (mobility, daily activities, self-care, pain/discomfort, anxiety/depression) as well as overall health status on a visual scale from 0 to 100

Time frame: From Day 0 to Week 24

Clinical Global Impression (CGI)

The clinician's overall assessment of the illness, including CGI-S (severity) and CGI-I (change). 7-point scale: CGI-S 1 = normal, 7 = extremely ill; CGI-I 1 = markedly improved, 7 = markedly worsened

Time frame: From Day 0 to Week 24

Patient Global Impression (PGI)

Patient's overall perception of the severity of their illness or change; a simple 7-point scale, self-reported. A high score is associated with patients perceiving their symptoms as severe

Time frame: From Day 0 to Week 24

Beck Depression Inventory-II (BDI-II)

BDI-II: a self-administered questionnaire consisting of 21 items that assess the severity of depressive symptoms over the past two weeks; score range: 0-63; thresholds: 0-13 (mild), 14-19 (moderate), 20-28 (severe), ≥29 (severe)

Time frame: From Day 0 to Week 24

Augmentation Severity Rating Scale (ASRS)

A 7-item self-administered questionnaire used to quantify the severity of the augmentation syndrome in patients treated with dopamine agonists. It assesses the worsening or early onset of RLS symptoms and their impact on sleep and daily activities

Time frame: From Day 0 to Week 24

Insomnia Severity Index (ISI)

To assess the severity of the patient's insomnia, taking into account both the quantity and quality of sleep, as well as its impact on daily functioning (fatigue, concentration, mood). A 7-item self-report questionnaire scored from 0 to 4, with a total score of 0-28; 0-7 indicates no insomnia, 8-14 mild, 15-21 moderate, and 22-28 severe insomnia

Time frame: From Day 0 to week 24

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts