Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.

• Status: Active, not recruiting
• Trial end date: 2022-09-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacity 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

Criteria

Inclusion Criteria:

• 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.

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