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COMPLETEDPHASE3

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

NCT04258839•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.

Eligibility

Age

5 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study
•Autism Spectrum Disorder
•Completion of 331-201-00148 trial
•Investigator assessment

Exclusion Criteria

•Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study
•Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose
•Female with positive pregnancy test

Locations (28)

Dothan Behavioral Medicine Clinic

Dothan, Alabama, United States

Southwest Autism Research and Resource Center

Phoenix, Arizona, United States

University of California San Francisco, Nancy Friend Pritzker Psychiatry

San Francisco, California, United States

APG Research

Orlando, Florida, United States

Autism Assessment, Research, Treatment and Services (AARTS) center

Chicago, Illinois, United States

Research site

Lake Charles, Louisiana, United States

The Lurie Center for Autism

Lexington, Massachusetts, United States

Research site

Bloomfield Hills, Michigan, United States

Thompson Center for Autism and Neurodevelopment

Columbia, Missouri, United States

Research site

Saint Charles, Missouri, United States

Key Dates

Start Date

January 23, 2020

Primary Completion Date

March 16, 2023

Completion Date

March 16, 2023

Last Updated

May 30, 2024

Enrollment

ACTUAL participants

Conditions

Irritability Associated With Autism Spectrum Disorder

Interventions

Brexpiprazole

DRUG

Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

NCT05555615

Irritability Associated With Autism Spectrum Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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