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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2024

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At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Pervasive child development disorders
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 02 May 2024 Efficacy primary end-points are also added to the study, hence making TU a trial focus.
    • 02 May 2024 Status changed from active, no longer recruiting to completed.
    • 01 Mar 2023 Planned End Date changed from 20 Aug 2022 to 30 Apr 2023.

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