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Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 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.

NCT03715166•Institut de Recherches Internationales Servier

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the efficacy and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

Detailed Description

The present study (CL3-95008-001) was performed in children and adolescents from 7 to less than 18 years old presenting with ASD. A 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg BID were assessed versus placebo. This double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg BID in which long term safety was evaluated.

Eligibility

Age

7 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients from 7 to less than 18 years
•Out patients
•Primary diagnosis of ASD as per Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (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

Exclusion Criteria

•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
•Severe electrolyte imbalance that is likely to interfere with the study conduct or evaluation

Locations (45)

Trial Tech em Pesquisas com Medicamentos Ltda

Curitiba, Brazil

Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

Fortaleza, Brazil

Hospital São Vicente de Paulo

Passo Fundo, Brazil

Universidade Federal de São Paulo, Escola Paulista de Medicina

São Paulo, Brazil

Faculdade de Medicina da Universidade de São Paulo - Departamento de Psiquiatria

São Paulo, Brazil

GSC CHU-LENVAL Centre ressource autisme

Nice, Alpes-Maritimes, France

Centre d'Investigation Clinique de Lyon

Bron, Auvergne-Rhône-Alpes, France

Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211

Bron, Auvergne-Rhône-Alpes, France

Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent

Strasbourg, Grand Est, France

Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent

Paris, Il de France, France

Key Dates

Start Date

September 24, 2018

Primary Completion Date

September 13, 2021

Completion Date

September 13, 2021

Last Updated

July 25, 2024

Enrollment

211

ACTUAL participants

Conditions

Autism Spectrum Disorder (ASD)

Interventions

Bumetanide Oral Solution

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder

Inclusion Criteria

Exclusion Criteria

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