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
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04258839
Collaborator
H. Lundbeck A/S (Industry)
100
1
1
31.1
3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 17, 2020
Anticipated Primary Completion Date :
Aug 20, 2022
Anticipated Study Completion Date :
Aug 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Brexpiprazole

Drug: Brexpiprazole
Oral tablet; taken once daily
Other Names:
  • OPC-34712
  • LuAF41156
  • Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [Baseline to Week 26]

      Adverse Events occurring from baseline to Week 26

    Secondary Outcome Measures

    1. Aberrant Behavior Checklist (ABC-I) [Baseline to Week 26]

      Aberrant Behavior Checklist- Irritability subscale score (ABC-I)

    2. Clinical Global Impression (CGI-S) [Baseline to Week 26]

      Clinical Global Impression - Severity (CGI-S)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding sites Princeton New Jersey United States 08540

    Sponsors and Collaborators

    • Otsuka Pharmaceutical Development & Commercialization, Inc.
    • H. Lundbeck A/S

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    ClinicalTrials.gov Identifier:
    NCT04258839
    Other Study ID Numbers:
    • 331-201-00191
    First Posted:
    Feb 6, 2020
    Last Update Posted:
    May 28, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 28, 2020