Bumetanide for the Autism Spectrum Clinical Effectiveness Trial - BASCET

niversitair Medisch Centrum Utrecht0 个研究点目标入组 172 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•1. Males or females aged *5 years to *15 years;
•2. Above clinical cut-off scores 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.

•1. Total IQ < 55 (WISC) 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 treatmen during studyt;
•6. Treatment with psychoactive medications, including antipsychotics 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.

发起方

niversitair Medisch Centrum Utrecht