EUCTR2014-001560-35-NL进行中（未招募）1 期
Bumetanide in Autism Medication and BIomarker study - BAMBI
Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Psychiatry, Utrecht , the Netherlands0 个研究点开始时间: 2016年1月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 =7 years to =15 years;
- •2.Criteria met for autism on Autism Diagnostic Observation Schedule - Generic (ADOS G) and Social Responsiveness Scale (SRS) (24).
- •3.Written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •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) 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.Serious, unstable illnesses including, gastroenterologic, respiratory, cardiovascular (QT interval lengthening), endocrinologic, immunologic, or hematologic disease;
- •3.Renal or hepatic dysfunction that would interfere with excretion or metabolism of Bumetanide;
- •4.Neurological disorders such as epilepsy, seizures and microcephaly;
- •5.Behavioral treatment
- •6.Treatment with psychoactive medications, including anticonvulsants, 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 or aminoglycosides.
- •8.Documented history of hypersensitivity reaction to sulfonamide derivatives.
研究者
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