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

EU CTIS

Registry ID

CTIS2024-520259-26-00

Acronym

CN012-0038

Enrollment

Registered

2025-08-26

Start date

2025-09-25

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Mania or Mania with Mixed Features in Bipolar-I Disorder

Brief summary

Occurrence of adverse events during the treatment period

Detailed description

Occurrence of adverse events leading to treatment discontinuation during the treatment period., Change in Columbia Suicide Severity Rating Scale (C-SSRS) responses during treatment period., Changes in measures of safety during the treatment period.

Interventions

DRUGKarXT

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of adverse events during the treatment period	—

Secondary

Measure	Time frame
Occurrence of adverse events leading to treatment discontinuation during the treatment period., Change in Columbia Suicide Severity Rating Scale (C-SSRS) responses during treatment period., Changes in measures of safety during the treatment period.	—

Countries

Bulgaria, Croatia, Hungary, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026