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

Sponsor ID
331-201-00191
Clinicaltrials.gov ID
NCT04258839
EudraCT ID
2018-004899-35
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-201-00191
Trial Details
Subscribe for updates
Age
5 - 17 Years
Therapeutic Area
  • Autism
    • Sex
    Female & Male
    Trial Dates
    Jan 2020 - Mar 2023
    Healthy Volunteers
    No
    • 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
    • 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

    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.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    95
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

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

    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
    Inclusion and Exclusion Criteria
    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

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    Dothan Behavioral Medicine Clinic
    Dothan, Alabama, United States, 36303
    Status
    N/A
    Location
    Southwest Autism Research and Resource Center
    Phoenix, Arizona, United States, 85006
    Status
    N/A
    Location
    University of California San Francisco, Nancy Friend Pritzker Psychiatry
    San Francisco, California, United States, 94143-3132
    Status
    N/A
    Location
    APG Research
    Orlando, Florida, United States, 32803
    Status
    N/A
    Location
    Autism Assessment, Research, Treatment and Services (AARTS) center
    Chicago, Illinois, United States, 60612
    Status
    N/A
    Location
    Research site
    Lake Charles, Louisiana, United States, 70629
    Status
    N/A
    Showing {first} - {last} of {total} Results

    © 2026 Otsuka America Pharmaceutical, Inc.

    All rights reserved.

    January 2026 01US25EUC0489

    We defy limitation,

    so that others can too.

    Follow Us
    OAPI and OPDC Locations

    508 Carnegie Center Dr,

    Princeton, NJ 08540, United States

    Phone +1 609-524-6788

    2440 Research Blvd,

    Rockville, MD 20850, United States

    Phone +1 301-424-9055

    3956 Point Eden Way

    Hayward, CA 94545, United States

    Phone +1 800-562-3974