Clinical Trial

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

Study acronym: BALSAM-1
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Protocol Amendment History 2 changes
notable Trial sites expanded: 69 -> 73 locations 2026-07-28
notable Trial sites expanded: 63 -> 69 locations 2026-06-27
Trial Details
NCT Number NCT06951698
Lead Sponsor Bristol-Myers Squibb
Conditions Bipolar-I Disorder With Mania or Mania With Mixed Features
Enrollment 274 participants
Start Date 2025-06-11
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-27