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NCT04174365 · ClinicalTrials.gov registry record · Phase 3

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
119
Enrollment target

NCT04174365 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 119 participants.

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The verdict

NCT04174365, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
119 participants
Enrollment target

Study Summary

The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.

Interventions

  • DRUG Placebo
  • DRUG Brexpiprazole

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2019-10-30
Est. Completion 2022-09-09
Phase Phase 3

What the Registry Record Tells You About NCT04174365

The ClinicalTrials.gov registry entry for NCT04174365 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04174365 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04174365 about?

NCT04174365 is a clinical study titled "Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder". The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.

What is the current status of trial NCT04174365?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2019-10-30. Estimated completion is 2022-09-09.

What interventions are being tested in trial NCT04174365?

The interventions under investigation include: Placebo (DRUG), Brexpiprazole (DRUG).

Who is sponsoring clinical trial NCT04174365?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 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.