NCT06929273

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is 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 (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

Conditions

• Bipolar Disorder Type I With Mania

Interventions

Type	Name	Description
DRUG	KarXT	Specified dose on specified days
DRUG	Lithium	Therapeutic dose
DRUG	Valproate	Therapeutic dose
DRUG	Lamotrigine	Therapeutic dose

Timeline

• Start date: 2025-07-18
• Primary completion: 2028-06-13
• Completion: 2028-06-13
• First posted: 2025-04-16
• Last updated: 2026-04-03

Locations

170 sites across 20 countries: United States, Argentina, Australia, Bulgaria, China, Croatia, Denmark, France, Hungary, India, Israel, Italy, Japan, New Zealand, Poland, Romania, Slovakia, Spain, Sweden, Ukraine

Regulatory

• FDA-regulated drug study