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
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
- 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.