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

Last updated: May 2, 2024
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

3

Condition

Autism

Asperger's Disorder

Williams Syndrome

Treatment

Brexpiprazole

Clinical Study ID

NCT04258839
331-201-00191
2018-004899-35
  • Ages 5-17
  • All Genders

Study 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 Criteria

Inclusion

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

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 topractice 2 different methods of birth control or remain abstinent during the trialand for 30 days after the last dose

  • Female with positive pregnancy test

Study Design

Total Participants: 95
Treatment Group(s): 1
Primary Treatment: Brexpiprazole
Phase: 3
Study Start date:
January 23, 2020
Estimated Completion Date:
March 16, 2023

Connect with a study center

  • Dothan Behavioral Medicine Clinic

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • University of California San Francisco, Nancy Friend Pritzker Psychiatry

    San Francisco, California 94143-3132
    United States

    Site Not Available

  • APG Research

    Orlando, Florida 32803
    United States

    Site Not Available

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

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Research site

    Lake Charles, Louisiana 70629
    United States

    Site Not Available

  • The Lurie Center for Autism

    Lexington, Massachusetts 02421-3114
    United States

    Site Not Available

  • Research site

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • Thompson Center for Autism and Neurodevelopment

    Columbia, Missouri 65211
    United States

    Site Not Available

  • Research site

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Alivation

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Center for Psychiatry and Behavioral Medicine Inc.

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Rutger's-New Jersey Medical Scholl Clinical Research Unit

    Newark, New Jersey 07103
    United States

    Site Not Available

  • For additional information regarding sites

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Bioscience Research

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Research site

    New York, New York 10036
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10314
    United States

    Site Not Available

  • Research Site

    Avon Lake, Ohio 44012
    United States

    Site Not Available

  • The Holloway Group, Inc

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Access Clinical Trials

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Research site

    Austin, Texas 78759
    United States

    Site Not Available

  • Cedar Health Research

    Dallas, Texas 75251
    United States

    Site Not Available

  • Research site

    San Antonio, Texas 78249
    United States

    Site Not Available

  • UT Health San Antonio Long School of Medicine, Department of Psychiatry and Behavioral Sciences

    San Antonio, Texas 78289
    United States

    Site Not Available

  • Family Psychiatry of the Woodlands

    The Woodlands, Texas 77381
    United States

    Site Not Available

  • Woodstock Research Center

    Woodstock, Vermont 05091
    United States

    Site Not Available

  • Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

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