A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
← catalyst calendarNCT06951711 · readout in 74 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
274estimated
Sites
85
Countries
China, Croatia, India +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-13 | actual | When the study began enrolling |
| Primary completion | 2026-11-02 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-11-02 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Bipolar Disorder Type I With Mania or Mania With Mixed Features
Interventions
- Drug: KarXT — also filed as BMS-986510, Xanomeline and trospium chloride
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from baseline in Young Mania Rating Scale (YMRS) score
measured At week 3
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