2026-525613-31-00招募中2 期
Intravenous iron in the management of drug-resistant restless legs syndrome: a randomized controlled delayed-start trial. IRON-RLS
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the change in the IRLSSG-Q score between visit V1 (baseline) and visit V3 (3 months after V1).
研究概览
简要总结
To evaluate the efficacy of intravenous ferric carboxymaltose (FCM) 1000 mg administered according to AASM guidelines, compared with conventional management according to SFRMS recommendations, on the change in IRLSSG-Q score between the baseline visit (V1) and the 3-month follow-up visit (V3), in patients with pharmacoresistant restless legs syndrome (RLS).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Be affiliated with a health insurance system
- •Written informed consent for participation in the study
- •Body weight ≥ 50 kg
- •Pharmacoresistant restless legs syndrome (RLS)
- •Severe to very severe RLS (IRLSSG-Q score >20), persistent or recurrent for more than one month
- •Treatment with dopamine agonists without exceeding recommended doses (ropinirole ≤ 2 mg/day, pramipexole ≤ 0.54 mg/day, rotigotine ≤ 3 mg/day)
- •Stable treatment with dopamine agonists and/or α2δ ligands and/or opioids for at least 3 months
- •In the presence of sleep apnea syndrome, treatment with continuous positive airway pressure (CPAP)
- •Fluent in spoken and written French
- •Agree to the automated processing of anonymized confidential data
排除标准
- •Iron supplementation (oral or intravenous) within the 6 months prior to inclusion and throughout the study period
- •Severe obstructive sleep apnea (apnea–hypopnea index >30/h) that is untreated, or in cases of refusal or failure of treatment
- •Known allergy, inflammatory or immune disorder
- •History of severe asthma, eczema, or any other atopic disease
- •Pregnancy or breastfeeding
- •Ongoing participation in a clinical study
- •Deprived of liberty by judicial or administrative decision
- •Living in a medicalized institution
- •Under legal protection
- •Failure to obtain consent
- •Serum ferritin <50 µg/L or >300 µg/L
- •Transferrin saturation coefficient <20% or >45%
- •Hemochromatosis
- •Augmentation syndrome in RLS
- •Treatment with antipsychotics or antidepressants
- •Known iron allergy
- •Severe infectious or inflammatory disease within the previous 3 months
- •RLS associated with chronic kidney disease, pregnancy, or a clinically significant neurological or psychiatric disorder
研究组 & 干预措施
FERRIC CARBOXYMALTOSE
Test
干预措施: FERRIC CARBOXYMALTOSE (Drug)
结局指标
主要结局
The primary outcome measure is the change in the IRLSSG-Q score between visit V1 (baseline) and visit V3 (3 months after V1).
The primary outcome measure is the change in the IRLSSG-Q score between visit V1 (baseline) and visit V3 (3 months after V1).
次要结局
- Change in the PLMS index between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group
- Change in other polysomnographic parameters (total sleep time, wake after sleep onset, percentage of slow-wave sleep, and rapid eye movement sleep) between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group.
- Serum biological parameters [between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group] and cerebrospinal fluid (CSF) parameters [at V1 in the immediate-treatment group and at V3 in the delayed-treatment group]: ferritin and transferrin saturation.
- CSF biological parameters prior to intravenous FCM infusion in the immediate-treatment group (V1) and in the delayed-treatment group (V3): ferritin and transferrin saturation.
- Clinical response defined as a decrease of ≥3 points in the IRLSSG-Q score between V1 and V3
- Change in ESS, ISI, BDI, ASRS, and EQ-5D scores between V1 and V3 in the immediate-treatment group and between V3 and V5 in the delayed-treatment group.
研究者
Clinical project manager
Scientific
Centre Hospitalier Universitaire De Montpellier
研究点 (1)
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