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

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) andAutism 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 conductof 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