Phase 3 Study to Assess the Safety and Effectiveness of KarXT in Japanese Adults with Acute Schizophrenia

What this Trial Is About

Researchers are evaluating the efficacy and safety of KarXT in adult Japanese participants who are acutely psychotic with schizophrenia. This Phase 3 study focuses on adults aged 18 to 65 years who meet specific criteria based on psychiatric evaluations and symptom severity scores. The trial aims to understand how KarXT affects schizophrenia symptoms compared to a placebo over a 5-week period, followed by a longer open-label extension. Participants are randomly assigned to receive either KarXT or a placebo during a 5-week double-blind treatment phase. Following this, they may enter a 52-week open-label extension where all participants receive KarXT. The study includes regular dosing on specified days, with careful monitoring throughout both phases. During their participation, individuals undergo assessments of symptom changes using scales like the Positive and Negative Syndrome Scale PANSS and Clinical Global Impressions-Severity CGI-S. Safety is closely monitored through reports of adverse events, physical exams, laboratory tests, heart rate and blood pressure measurements, and other evaluations. The total study duration can last over a year, allowing for detailed observation of treatment effects and safety over time.

A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia