drugset / Trial / NCT07140913

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

Phase 3 Recruiting 424 enrolled Bristol-Myers Squibb
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Timeline

Start
2025-10-08
Primary completion
2027-06-28
Completion
2027-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Trospium Small molecule
Subject Xanomeline Small molecule