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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03715166
Other study ID # CL3-95008-001
Secondary ID 2017-004419-38
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 24, 2018
Est. completion date September 13, 2021

Study information

Verified date March 2022
Source Servier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 211
Est. completion date September 13, 2021
Est. primary completion date September 13, 2021
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility 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

Study Design


Intervention

Drug:
Bumetanide Oral Solution
Oral Solution dosed at 0.5mg/mL Taken twice daily
Placebo
Oral Solution Taken twice daily

Locations

Country Name City State
Brazil 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 Faculdade de Medicina da Universidade de São Paulo - Departamento de Psiquiatria São Paulo
Brazil Universidade Federal de São Paulo, Escola Paulista de Medicina São Paulo
France Centre Hospitalier Charles Perrens CRA Aquitaine Bordeaux Nouvelle-Aquitaine
France Hôpital des Enfants-Pellegrin Bordeaux Nouvelle Aquitaine
France Centre d'Investigation Clinique de Lyon Bron Auvergne Rhone Alpes
France Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211 Bron Auvergne-Rhône-Alpes
France GSC CHU-LENVAL Centre ressource autisme Nice Alpes-Maritimes
France Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent Paris Il De France
France CHU Rouen Rouen Normandie
France Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme Sotteville-lès-Rouen Normandie
France Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent Strasbourg Alsace-Champagne-Ardenne-Lorraine
Germany Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und Dresden Saxony (Sachsen)
Germany Universitätsklinikum Freiburg, Zentrum für Psychische Erkrankungen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter Freiburg Baden-Württemberg
Germany Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters am Zentralinstitut für Seelische Gesundheit Mannheim Baden-Württemberg
Hungary Servus Salvus Kft. Budapest
Hungary Vadaskert Korhaz es Szakambulancia Budapest
Hungary Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly Gyula
Hungary Szegedi Tudományegyetem Szent-Gyorgy Albert Klinikai Kozpont Gyermekgyógyászati Klinika Gyermek es Ifjusagpszichiátriai o Szeged
Italy Neuro Riabilitazione/Psicopatologia dell'età evolutiva Istituto Scientifico Medea - Bosisio Parini Bosisio Parini Lombardia
Italy Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza Ospedale Pediatrico-Microcitemico Cagliari Sardegna
Italy U.O.C. Psichiatria dello Sviluppo IRCCS Fondazione Stella Maris Calambrone Toscana
Italy Programma Interdipartimentale "Autismo 0-90" A.O.U. Policlinico "Gaetano Martino" Messina Sicilia
Italy Unità Semplice di Psichiatria Infantile Policlinico Universitario di Napoli - Università Federico II Napoli Campania
Italy U.O. di Neuropsichiatria Infantile Fondazione Istituto Neurologico Nazionale Casimiro Mondino Istituto di Ricovero e Cura a Carattere Scientifico Pavia Lombardia
Italy U.O. di Neuropsichiatria Infantile Azienda Ospedaliera Universitaria Senese Siena Toscana
Netherlands Accare Groningen Groningen
Poland Centrum Badan Klinicznych PI-House sp. z o.o Gdansk
Poland Niepubliczny Zaklad Opieki Zdrowotnej Gdanskie Centrum Zdrowia Sp. z o.o. Gdansk Wojewodztwo Pomorskie
Poland NAVICULA Centrum Diagnozy i Terapii Autyzmu w Lodzi Lodz Wojewodztwo Lodzkie
Poland Fundacja SYNAPSIS ul. Warszawa
Poland Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie Oddzial Kliniczny Psychiatrii Wieku Rozwojowego Warszawa Wojewodztwo Mazowieckie
Portugal Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico Coimbra
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Niño Jesus Madrid
Spain Hospital Universitario Gregorio Marañon Madrid
Spain Hospital Puerta de Hierro Majadahonda Madrid
Spain Policlinica Guipuzcoa San Sebastian Guipuzcoa
Spain Hospita Mutua de Terrassa Terrassa Barcelona
United Kingdom Forward Thinking Birmingham_Birmingham Women's and Children's NHS Foundation Trust Birmingham
United Kingdom ReCognition Health London
United Kingdom The Winnicott Centre Manchester

Sponsors (2)

Lead Sponsor Collaborator
Institut de Recherches Internationales Servier ADIR, a Servier Group company

Countries where clinical trial is conducted

Brazil,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Childhood Autism Rating Scale, Second Edition (CARS2) total raw score Efficacy criterion The CARS2 is a 15 item rated instrument. The rating values given for the 15 areas are summed to produce a Total score. Change from baseline to 6 month
Secondary Social Responsiveness Scale, Second Edition (SRS-2) total raw score Efficacy criterion 65 items scale measuring symptoms associated with autism Change from baseline to 6 month
Secondary Clinical Global Impression - Global Improvement (CGI-I) score Efficacy criterion Scale which assesses the severity of the illness and the global improvement of the patient under study treatment At 6 months
Secondary Vineland Adaptative Behaviour Sales, Second Edition (VABS II) subscores Efficacy criterion Scale designated to measure adaptative behaviour Change from baseline to 6 month
Secondary Adverse events and Paediatric Adverse Event Rating Scale (PAERS) Safety criterion Inventory report used to identify signs/symptoms experienced by the patient since the study treatment initiation. On average of 52 weeks
Secondary Abnormalities in 12-leads electrocardiogram (ECG) parameters Safety criterion selection visit/Week004/Week008/Week012/Week 026/Week030/Week034/Week038/Week052
Secondary Renal ultrasound Safety criterion Assessment of the renal function selection visit/Week026/Week052
Secondary the Columbia Suicide Severity Rating Scale Children's version (C-SSRS-C) Scale which assesses suicidal ideation and suicidal behaviour Week000/Week012/Week026/Week038/Week052
Secondary Tanner stage Safety criterion Assessment of Pubertal development Week000/Week026/Week052
Secondary Acceptability and palatability questionnaire Acceptability and palatability criterion Assessment of the ease of use to use the dosing device Week026
Secondary Paediatric Quality of Life Inventory (PedsQL) questionnaire Quality of Life criterion Assessment of parent/legal representative perception of patient health related quality of life Week000/Week004/Week012/Week026/Week030/Week038/Week052
See also
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