Otsuka Pharmaceutical and Lundbeck announce that patient enrollment has been initiated in two global Phase 3 clinical trials to evaluate brexpiprazole for the treatment of patients with manic episodes associated with bipolar I disorder.
The Phase 3 trials will evaluate the efficacy of brexpiprazole in patients with bipolar I disorder who are experiencing an acute manic episode, with or without mixed features, that requires hospitalization. The characterization of mixed features indicates that at least three symptoms of depression accompany the manic episode.
The trials are multicenter, randomized, double-blind studies of brexpiprazole versus placebo. The primary endpoint is the mean change from baseline to Day-21 endpoint in the Young-Mania Rating Scale (YMRS) total score. The YMRS score is a widely used clinician rating scale to assess mania symptoms based on a patient’s subjective reports of their condition and clinical observations made during interviews.
The key secondary endpoint is the change from baseline to Day 21 in the double-blind treatment period in Clinical Global Impression – Bipolar (CGI BP) severity-of-illness score in mania. The studies also include a number of other endpoints, including monitoring of safety and tolerability.