EUCTR2017-004420-30-ES进行中（未招募）1 期
Efficacy and safety of bumetanide oral liquid formulation in children aged from 2 to less than 7 years old with Autism Spectrum Disorder.A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 211
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
- •- Male and female patients from 2 to less than 7 years
- •- Out patients
- •- Primary diagnosis of ASD as per DSM-5 criteria
- •- Criteria met for ASD on Autism Diagnostic Observation Schedule (ADOS-2) and Autism Diagnosis Interview Revised (ADI-R)
- •- CGI (Clinical Global Impression) – Severity rating Score = 4
- •- Childhood Autism Rating Scale second edition (CARS2-ST or HF) total
- •raw score = 34
- •- Social Responsiveness Scale second edition total score (SRS-2 T-Score) = 66
- •- Absence of known monogenic syndrome (Fragile X, Rett syndrome ...)
- •- Absence of any clinically significant abnormality likely to interfere with the conduct of the study according to the judgment of the investigator
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •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
- •- Patients not able to follow the study assessments defined by the protocol, with the exception of self-rating questionnaires which will be assessed by parent/legal representative/caregiver for those patients unable to complete them
- •- Patients having a high suicidal risk according to the investigator judgement
- •- Chronic renal dysfunction
- •- Chronic cardiac dysfunction
- •- Patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural therapy
- •- Absence of electrolyte imbalance that is likely to interfere with the study conduct or evaluation
研究者
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