Status: Recruiting
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
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.
Participants needed: 450
Trial details
Phase: Phase 3Age: 18-65Biological sex: AllType: InterventionalSponsor: Bristol-Myers SquibbUpdated: Aug 25, 2026Locations: 174
Eligibility criteria
Participants must have primary diagnosis of Bipolar-I disorder established by a... [+3]
Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4... [+5]