A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520195-94-00

Acronym

CN012-0037

Enrollment

Registered

2025-08-28

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

BP-I mania or mania with mixed features

Brief summary

Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 3.

Detailed description

Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 3., Occurrence of TEAEs, SAEs, and TEAEs leading to treatment discontinuation and change in C-SSRS responses during the treatment period., Change from baseline in BARS, SAS, AIMS, and IPSS (males aged ≥ 45 years only) at Week 3.

Interventions

DRUGKarXT Matching Placebo

DRUGKarXT

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 3.	—

Secondary

Measure	Time frame
Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 3., Occurrence of TEAEs, SAEs, and TEAEs leading to treatment discontinuation and change in C-SSRS responses during the treatment period., Change from baseline in BARS, SAS, AIMS, and IPSS (males aged ≥ 45 years only) at Week 3.	—

Countries

Croatia, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

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