MedTrace Logo

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

NCT04174365 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-08-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Irritability Associated With Autism Spectrum Disorder (ASD)

Interventions

DRUG

Brexpiprazole

Oral tablet; take once daily

DRUG

Placebo

Administered orally daily for up to Week 8.

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2022-08-08
Completion
2022-09-09
FDA Drug
Yes

Countries

  • United States

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 NCT04174365 on ClinicalTrials.gov