Intravenous Iron in the Management of Drug-resistant Restless Legs Syndrome: a Randomized Controlled Delayed-start Trial. IRON-RLS
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- IRLSSG-Q score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Immediate treatment
The treatment will be administered at at baseline (V1), immediately after the baseline polysomnography
干预措施: Ferric Carboxymaltose Injection [Ferinject] (Drug)
Immediate treatment
The treatment will be administered at at baseline (V1), immediately after the baseline polysomnography
干预措施: Randomization (Other)
Immediate treatment
The treatment will be administered at at baseline (V1), immediately after the baseline polysomnography
干预措施: Questionnaire and Physical Exam (Other)
Immediate treatment
The treatment will be administered at at baseline (V1), immediately after the baseline polysomnography
干预措施: lumbar puncture (Procedure)
Immediate treatment
The treatment will be administered at at baseline (V1), immediately after the baseline polysomnography
干预措施: urine pregnancy test (Procedure)
Delayed-onset treatment
The treatment will be administered at 12 weeks
干预措施: Ferric Carboxymaltose Injection [Ferinject] (Drug)
Delayed-onset treatment
The treatment will be administered at 12 weeks
干预措施: Randomization (Other)
Delayed-onset treatment
The treatment will be administered at 12 weeks
干预措施: Questionnaire and Physical Exam (Other)
Delayed-onset treatment
The treatment will be administered at 12 weeks
干预措施: lumbar puncture (Procedure)
Delayed-onset treatment
The treatment will be administered at 12 weeks
干预措施: urine pregnancy test (Procedure)
结局指标
主要结局
IRLSSG-Q score
时间窗: From Day 0 to Week 12
IRLSSG-Q : International Restless Legs Study Group Severity Rating Scale allows for the quantification of the severity of restless legs syndrome
次要结局
- Periodic Limb Movements during Sleep (PLMS) index(From V1 (Day 0) to V5 (week 24))
- Total sleep time(From day 0 to week 24)
- Sleep latency(From Day 0 to week 24)
- Sleep time at stage 1-2 during polysomnography(From Day 0 to week 24)
- Transferrin saturation coefficient(From Day 0 to Week 24)
- Sleep time at stage 3 during polysomnography(From Day 0 to week 24)
- Micro-awakenings index (MAI)(From Day 0 to week 24)
- Apnea-hypopnea index (AHI)(From Day 0 to week 24)
- Average arterial oxygen saturation (SaO2)(From Day 0 to Week 24)
- Oxygen desaturation index (IDO)(From Day 0 to week 24)
- Serum ferritin(From Day 0 to week 24)
- Epworth Sleepiness Scale (ESS)(From Day 0 to Week 24)
- European Quality of Life 5 Dimensions (EQ-5D)(From Day 0 to Week 24)
- Clinical Global Impression (CGI)(From Day 0 to Week 24)
- Patient Global Impression (PGI)(From Day 0 to Week 24)
- Beck Depression Inventory-II (BDI-II)(From Day 0 to Week 24)
- Augmentation Severity Rating Scale (ASRS)(From Day 0 to Week 24)
- Insomnia Severity Index (ISI)(From Day 0 to week 24)