EUCTR2016-002875-81-NL进行中（未招募）1 期
Bumetanide for the Autism Spectrum Clinical Effectiveness Trial - BASCET
MC Utrecht0 个研究点目标入组 172 人开始时间: 2016年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 172
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Males or females aged =5 years to =15 years;
- •2.Above clinical cut-off scores of altered sensory reactivity on the Sensory Profile and either a clinical ASD or ADHD diagnosis based on DSM-5 (or DSM-IV) or an epilepsy diagnosis;
- •3.Written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 172
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Total IQ < 55 (WISC or WPPSI) and/or inability to comply with the protocol-specified procedures for the duration of the study, including treatment, blood sampling to control diuretic effects;
- •2.Presence of a severe medical or genetic disorder other than related to ASD or epilepsy;
- •3.Serious, unstable illnesses including, gastroenterological, respiratory, cardiovascular (arrhythmias, QT interval lengthening), endocrinologic, immunologic, hematologic disease, dehydration or hypotension, electrolyte disturbances (Na <133 mmol/L, K <3.5 mmol/L or Ca <2.17 mmol/L (<13y) or <2.2 mmol/L (>13y);
- •4.Renal insufficiency (CKD st2-5; estimated glomerular filtration rate < 90 ml/min/1.73m2), congenital or acquired renal disease with decreased concentration capacity (tubulopathy, diabetes insipidus) and liver insufficiency interfering with excretion or metabolism of bumetanide;
- •5.Start of behavioural treatment during study;
- •6.Treatment with psychoactive medications, including antipsychotics, psychostimulant drugs and AEDs, except methylphenidate, is allowed albeit on a stable regime in terms of types and dosage from 2 months prior to the study to the end of the study;
- •7.Treatment with NSAIDS, aminoglycosides, digitals, antihypertensive agents, indomethacin, probenecid, acetazolamide, Lithium, other diuretics (e.g., furosemide, hydrochlorothiazide), drugs known to have a nephrotoxic potential;
- •8.Documented history of hypersensitivity reaction to sulfonamide derivatives;
- •9. Body weight <17 kg.
研究者
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