Bumetanide for the Autism Spectrum Clinical Effectiveness Trial - BASCET

MC Utrecht0 个研究点目标入组 172 人2016年10月25日

适应症Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Epilepsy MedDRA version: 20.0Level: LLTClassification code 10008520Term: Childhood autismSystem Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0Level: PTClassification code 10063844Term: Autism spectrum disorderSystem Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0Level: LLTClassification code 10061345Term: Pervasive developmental disorderSystem Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0Level: LLTClassification code 10003805Term: AutismSystem Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0Level: LLTClassification code 10034739Term: Pervasive developmental disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 10037175 - Psychiatric disorders Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Epilepsy
发起方: MC Utrecht
入组人数: 172
状态: 进行中（未招募）
最后更新: 5年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2016年10月25日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

MC Utrecht

入排标准

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.