Overview

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