2024-512117-40-00招募中3 期
Prospective analysis of the therapeutic efficacy of iron isomaltoside in combination with or without dopaminergic therapy in patients with restless legs syndrome
Medizinische Universitaet Innsbruck1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年10月14日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Changes in RLS severity as detected by the IRLS
研究概览
简要总结
Main objective of this study is to investigate the effect of iron supplementation or placebo (in combination or not with dopaminergic therapy) on clinical RLS symptoms measured by the IRLS.
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-Up Visit 2
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •RLS diagnosed according to the current IRLSSG criteria Essential diagnostic criteria (all must be met): a) An urge to move the legs usually but not always accompanied by, or felt to be caused by, uncomfortable and unpleasant sensation in the legs. b) The urge to move the legs and any accompanying unpleasant sensations begin or worsen during periods of rest or inactivity such as lying down or sitting c) The urge to move the legs and any accompanying unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. d) The urge to move the legs and any accompanying unpleasant sensations during rest or inactivity only occur or are worse in the evening or night than during the day. d) The occurence of the above features is not solely accounted for as symptoms primary to another medical or a behavioral condition (e.g. myalgia, venous stasis, leg edema, arthritis, leg cramps, positional discomfort, habitual foot tapping).
- •Female and male participants aged ≥ 18 years
- •Negative urine/serum pregnancy test in women of childbearing potential (WOCBP). WOCBP who are sexually active, agree to use highly effective means of contraception during the study and for at least 1 month post-study treatment. Allowed are accepted and effective hormonal/non-hormonal methods of contraception and sexual abstinence or vasectomised partners (> 3 months previously). Vasectomy has to be confirmed by two negative semen analyses.
- •IRLS score >=15
- •For the DA group, DA dosage not exceeding the max recommended dosage for RLS (PMID 27448465): Pramipexole 0.75 mg/day, Ropinirole 4mg/day, Rotigotine 3 mg/day
- •Written, signed and dated informed consent
排除标准
- •Secondary RLS
- •Ferritin > 200 mg/dL or Transferrin Saturation over 45%
- •Phosphate levels below the lower limit normal before study drug initiation
- •Contraindications for performing a MRI (for example claustrophobia, pacemakers, metal implants)
- •Body weight < 50 kg
- •Known Hypersensitivity to the active substance or any of its excipients (Sodium hydroxide/Hydrochloric acid
- •Sporadic RLS
- •Dialysis-dependent renal failure (eGFR<20mL/min/1.73m² calculated by MDRD formula)
- •Moderate or severe heart failure (NYHA III - IV)
- •Malignancies
- •Pregnancy/brestfeeding
- •Known thalassaemia minima/minor, hemochromatosis, polycythemia vera, hemolytic anemia
- •Current intake of opiates
- •Iron substitution, erythropoietin therapy or blood transfusion in the previous 6 months
结局指标
主要结局
Changes in RLS severity as detected by the IRLS
Changes in RLS severity as detected by the IRLS
次要结局
- Changes in RLS severity as detected by the sIRLS, RLS-6 and CGI
- Changes in blood count, iron, Tf, TSAT, ferritin, sTfR, hepcidin-25, creatinine (GFR), GPT, GOT, LDH, CRP, electrolytes (Na, K, P, Ca), PTH, LCN2, dopamine, 1,25-(OH)2 vitamin D, 25-OH vitamin D, EPO, ERFE, PDGF-BB, LCN2 and metabolites (ATP, NADH/NAD, Lactate, Succinate, Citrate, Pyruvate, free fatty acids)
- Changes in mitochondrial iron and Krebs cycle metabolism gene expression in monocytes detected by RT-PCR
- Changes in mitochondrial respiration of selected and randomly assigned patients measured with OROBOROS respirometry
- Changes in iron content in the substantia nigra detected by an MRI in a subgroup of 80 patients (20 dopaminergic therapy/iron, 20 dopaminergic therapy/placebo, 20 no previous treatment/iron and 20 no previous treatment/placebo)
研究者
University Hospital for Neurology
Scientific
Medizinische Universitaet Innsbruck
研究点 (1)
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