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NCT03715153 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Institut de Recherches Internationales Servier.

Terminated
Registry status
Phase 3
Development phase
211
Enrollment target

NCT03715153 is a Phase 3 study that was terminated before completion, run by Institut de Recherches Internationales Servier. The registered enrollment target is 211 participants.

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The verdict

NCT03715153, a Phase 3 study, was terminated before completion, sponsored by Institut de Recherches Internationales Servier.

TERMINATED
Registry status
Phase 3
Development phase
211 participants
Enrollment target

Study 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.

Interventions

  • DRUG BUMETANIDE (S95008) for week 0 - 26
  • DRUG PLACEBO for week 0 - 26
  • DRUG Open-Label BUMETANIDE (S95008) for weeks 26 - 52

Trial Details

FieldValue
Enrollment Target 211 participants
Start Date 2018-10-04
Est. Completion 2021-10-26
Phase Phase 3

What the Registry Record Tells You About NCT03715153

The ClinicalTrials.gov registry entry for NCT03715153 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which BUMETANIDE (S95008) for week 0 - 26 is the first listed.

NCT03715153 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03715153 about?

NCT03715153 is a clinical study titled "Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.". 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.

What is the current status of trial NCT03715153?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2018-10-04. Estimated completion is 2021-10-26.

What interventions are being tested in trial NCT03715153?

The interventions under investigation include: BUMETANIDE (S95008) for week 0 - 26 (DRUG), PLACEBO for week 0 - 26 (DRUG), Open-Label BUMETANIDE (S95008) for weeks 26 - 52 (DRUG).

Who is sponsoring clinical trial NCT03715153?

This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.