Autism Spectrum Disorder (ASD) Clinical Trial
Official title:
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.
Verified date | March 2022 |
Source | Servier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherches Internationales Servier | ADIR, a Servier Group company |
Brazil, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom,
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 |
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