A Phase 3 Open-label Extension Study to Assess the Long-term Safety of KarXTfor the Treatment of Manic Episodes in Bipolar-I Disorder

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(BALSAM-3)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041250099

Enrollment

300

Registered

2025-09-18

Start date

2025-09-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar-I Disorder

Interventions

KarXT xanomeline/trospium chloride 50 mg/20 mg, 75 mg/20 mg, 100 mg/20 mg or 125 mg/30 mg capsule BID

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Completed treatment period of parent study(CN0120036 or CN0120037)

Exclusion criteria

Exclusion criteria: Risk for suicidal behavior at baseline as determined by the Investigator's clinical assessment, and/or C-SSRS as confirmed by the following: -Answer "Yes" on items 4 or 5 (C-SSRS -ideation) since last visit -Answer "Yes" to any of the 5 items (C-SSRS behavior) since last visit -Suicide attempt during the parent study. Discontinuation from any KarXT parent studies.

Design outcomes

Primary

Measure	Time frame
Occurrenceof TEAEsduring the treatment period.	—

Secondary

Measure	Time frame
Occurrenceof AESIs, SAEs and TEAEs leading to treatment discontinuationduring the treatment period. Change in C-SSRSresponses during the treatment period. Change from baseline in BARS, SAS, AIMS, andIPSS (males>=45 yearsof age only)during the treatment period.	—

Countries

Argentina, Australia, Brazil, Bulgaria, Croatia, France, Greece, Hungary, India, Israel, Japan, New Zealand, Norway, Poland, Romania, Serbia, Slovakia, Spain, Sweden, United States

Contacts

Public ContactLauren Moran

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026