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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

NCT03715166 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2024-07-25

No results posted yet for this study

Summary

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.

Conditions

  • Autism Spectrum Disorder (ASD)

Interventions

DRUG

Bumetanide Oral Solution

Oral Solution dosed at 0.5mg/mL Taken twice daily

DRUG

Placebo

Oral Solution 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
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2021-09-13
Completion
2021-09-13

Countries

  • Brazil
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03715166 on ClinicalTrials.gov