NCT04174365

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Brexpiprazole	Oral tablet; take once daily
DRUG	Placebo	Administered orally daily for up to Week 8.

Timeline

• Start date: 2019-10-30
• Primary completion: 2022-08-08
• Completion: 2022-09-09
• First posted: 2019-11-22
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study