Clinical Trial

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Recruiting Phase 3
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Summary
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
Protocol Amendment History 3 changes
notable Trial sites expanded: 78 -> 85 locations 2026-07-21
notable Trial sites expanded: 74 -> 78 locations 2026-06-05
notable Trial sites expanded: 69 -> 74 locations 2026-04-30
Trial Details
NCT Number NCT06951711
Lead Sponsor Bristol-Myers Squibb
Conditions Bipolar Disorder Type I With Mania or Mania With Mixed Features
Enrollment 274 participants
Start Date 2025-06-13
Primary Completion 2026-11-02 (estimated)
Study Completion 2026-11-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-20