A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Trial Profile

A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2018

At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Agitation
  • Focus Therapeutic Use
  • Sponsors Otsuka Pharmaceutical
  • Most Recent Events

    • 05 Jun 2018 Status changed from planning to recruiting.
    • 23 May 2018 According to a Lundbeck media release, based on the decision of the US FDA, the company is planning to start this third Phase 3 study for the agitation in Alzheimer's disease. The FDA's decision was based on the results of the two completed phase 3 study ( CTP: 247111 and 233327).
    • 23 May 2018 According to a Lundbeck Inc media release, this study will commence in June 2018.
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