Otsuka and Lundbeck announce that the two companies’ third clinical Phase 3 study of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type will commence in June.
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Approximately 300 patients are expected to be enrolled in this 12-week, randomized, double-blind, placebo-controlled trial. Additional information about the trial will be available in the near future at clinicaltrials.gov and will be updated periodically following initiation of the study.
The decision to initiate a third trial follows discussions with the U.S. Food and Drug Administration (FDA) regarding two Phase 3 clinical trials for the agitation in Alzheimer’s disease indication that were completed by Otsuka and Lundbeck in 2017. Results for the two completed trials were announced in May of last year and presented in poster sessions at the American Association for Geriatric Psychiatry annual meeting in March of this year.