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A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

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Trial Profile

A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Jul 2023

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At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Agitation; Alzheimer's disease; Dementia
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical

    • Most Recent Events

    • 27 Jun 2023 According to Otsuka Pharmaceutical media release, base on study outcome company is planning a regulatory filing in Japan later in 2023 for an additional treatment indication for brexpiprazole.
    • 27 Jun 2023 According to Otsuka Pharmaceutical media release, aditional analysis of the trial results is planned to further interpret the efficacy and safety of brexpiprazole for the treatment indication.
    • 27 Jun 2023 Primary endpoint (Mean change from baseline in Cohen-Manfield Agitation Incentory(CMAI) score at 10 weeks) has been met, according to Otsuka Pharmaceutical media release.
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