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

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 MentalDisorders - Fifth Edition (DSM-5) criteria

• Criteria met for ASD on Autism Diagnostic Observation Schedule (ADOS-2) and AutismDiagnosis 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 theconduct 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 theexception of self-rating questionnaires which will be assessed by parent/legalrepresentative/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-behaviouraltherapy

• Severe electrolyte imbalance that is likely to interfere with the study conduct orevaluation