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. - Efficacy +safety of bumetanide in children from 2 to less than 7 with ASD.

Servier R&D Benelux0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- 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
•-Absence of electrolyte imbalance that is likely to interfere with the study conduct or evaluation

•- 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

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