Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Autism Spectrum Disorder (ASD)
In brief
The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.
Key facts
- Study ID
- NCT03715153
- Run by
- Institut de Recherches Internationales Servier
- People needed
- 211
- Starts
- 2018-10-04
- Expected to finish
- 2021-10-26
- Last updated by the study team
- 2023-06-05
Who can join
Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female patients from 2 to less than 7
- 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-Generic (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 (SRS-2) total score ≥ 66 T-Score
- Absence of diagnosis of Fragile X or Rett Syndrome
- Absence of any clinically significant abnormality likely to interfere with the conduct of the study according to the judgment of the investigator.
You may not qualify if…
- 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
Where it is running
- Richmond Behavioral Associates — Staten Island, New York, United States
- Liverpool Hospital — Liverpool, Australia
- The Royal Children's Hospital Melbourne — Parkville, Australia
- Trial Tech em Pesquisas com Medicamentos Ltda — Curitiba, Brazil
- Hospital Universitário Walter Cantídio-Universidade Federal do Ceará — Fortaleza, Brazil
- Clínica Neurológica e Neurocirúrgica de Joinville — Joinville, 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 psiquiatra — São Paulo, Brazil
- University hospital of Ostrava, Department of Psychiatry — Poruba, Ostrava, Czechia
- University Hospital Brno, Department of Child Neurology — Brno, Czechia
- Institute of Neuropsychiatric Care, Department of Child Psychiatry — Prague, Czechia
- 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
- Centre Hospitalier Charles Perrens CRA Aquitaine — Bordeaux, New Aquitaine, France
- Hôpital des Enfants-Pellegrin — Bordeaux, New Aquitaine, France
- CHU Rouen — Rouen, Normandy, France
- Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme — Sotteville-lès-Rouen, Normandy, France
- Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent — Paris, Île-de-France Region, France
- Vadaskert Korhaz es Szakambulancia — Budapest, Hungary
- Servus Salvus Kft. — Budapest, Hungary
- Magyar Református Egyház Bethesda Gyermekkórháza — Budapest, Hungary
- Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly — Gyula, Hungary
Full record on ClinicalTrials.gov
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