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

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Servier

Status and phase

Terminated
Phase 3

Conditions

Autism Spectrum Disorder (ASD)

Treatments

Drug: Bumetanide Oral Solution
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03715166
2017-004419-38 (EudraCT Number)
CL3-95008-001

Details and patient eligibility

About

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

Full description

The present study (CL3-95008-001) was performed in children and adolescents from 7 to less than 18 years old presenting with ASD. A 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg BID were assessed versus placebo. This double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg BID in which long term safety was evaluated.

Enrollment

211 patients

Sex

All

Ages

7 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

211 participants in 2 patient groups, including a placebo group

Bumetanide/S95008
Experimental group
Treatment:
Drug: Bumetanide Oral Solution
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

45

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Data sourced from clinicaltrials.gov

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