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

Study 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 / Drugs

KarXT Lithium Valproate Lamotrigine

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment450 participants

Primary Completion—

Lead SponsorBristol-Myers Squibb

Data Retrieved2026-04-11 04:08:14.745958+00:00

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