Overview

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Status:
RECRUITING
Trial end date:
2028-06-13
Target enrollment:
Participant gender:
Summary
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
Phase:
PHASE3
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
trospium chloride
xanomeline