A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

• Status: Recruiting
• Trial end date: 2023-12-01

Summary

This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score. The secondary objectives of the study are to evaluate the efficacy of adjunctive KarXT compared with placebo on the Personal and Social Performance Scale (PSP), improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics.

• Phase: Phase 3

Details

• Lead Sponsor: Karuna Therapeutics
• Treatments: Trospium chloride; Xanomeline