Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
notable Trial sites expanded: 172 -> 175 locations 2026-07-16
Trial Details
NCT Number NCT06929273
Lead Sponsor Bristol-Myers Squibb
Conditions Bipolar Disorder Type I With Mania
Enrollment 450 participants
Start Date 2025-07-18
Primary Completion 2028-06-13 (estimated)
Study Completion 2028-06-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-24