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

NCT03715153 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2023-06-05

Study results available
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Summary

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

Conditions

  • Autism Spectrum Disorder (ASD)

Interventions

DRUG

BUMETANIDE (S95008) for week 0 - 26

Oral solution dosed at 0.5 mg/mL Taken twice daily.

DRUG

PLACEBO for week 0 - 26

Oral solution Taken twice daily.

DRUG

Open-Label BUMETANIDE (S95008) for weeks 26 - 52

Oral solution dosed at 0.5 mg/mL Taken twice daily.

Sponsors & Collaborators

  • ADIR, a Servier Group company

    collaborator INDUSTRY

  • Institut de Recherches Internationales Servier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2021-10-26
Completion
2021-10-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Czechia
  • France
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715153 on ClinicalTrials.gov