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

• Status: Active, not recruiting
• Trial end date: 2021-12-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Internationales Servier
• Collaborator: ADIR, a Servier Group company
• Treatments: Bumetanide; Pharmaceutical Solutions

Criteria

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