NL-OMON44696已完成2 期
Bumetanide in Autism Medication and Biomarker study<br> - BAMBI
niversitair Medisch Centrum Utrecht0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •1. Males or females aged *7 years to *15 years;
- •2. Criteria met for autism spectrum disorder and on DSM-V Social Responsiveness Scale (SRS) (24).
- •3. Written informed consent.
排除标准
- •1. Total IQ < 55 (WISC) and/or inability to comply with the protocol-specified procedures for the duration of the study, including treatment and blood sampling to control diuretic effects.
- •2. Serious, unstable illnesses including, gastroenterologic, respiratory, cardiovascular (arythmias, QT interval lengthening), endocrinologic, immunologic, hematologic disease, dehydration or hypotension;
- •3. Renal insufficiency (CKD st2-5; estimated glomerular filtration rate < 90 ml/min/1.73m2), congential or acquired renal disease with decreased concentration capacity (tubulopathy, diabetes insipidus) and liverinsufficiency interfering with excretion or metabolism of Bumetanide;
- •4. Neurological disorders such as epilepsy, seizures and microcephaly;
- •5. Start of behavioral treatment during study
- •6. Treatment with psychoactive medications (antipsychotics, antidepressants, anxiolytic drugs, psychostimulant drugs or other medication with effect on the central nervous system, including anti-epileptic drugs) in the last 8 weeks prior to start of the study, except melatonin; no use of other psychoactive substances is allowed from 8 weeks prior to the pre-study evaluation until the endpoint measurements at the end of the washout period. If clinically feasible and desired by the patients and/or parents, then it is allowed to stop psychoactive medication to allow enrollment in the study after a 8 week washout period of their psychoactive medication.
- •7. Treatment with NSAIDS, aminoglycosides, digitals, antihypertensive agents, indomethacin, probenecid, Lithium, other diuretics (e.g. furosemide, hydrochlorothiazide), drugs known to have a nephrotoxic potential
- •8. Documented history of hypersensitivity reaction to sulfonamide derivatives.
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