clinical trial · NCT06929273
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bristol-Myers Squibb·phase3·recruiting·n = 450
Bipolar Disorder Type I With ManiaKarXTLithiumValproateLamotrigine
brief 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.
started
Jul 18, 2025
primary completion
Jun 13, 2028
completion
Jun 13, 2028
last updated
Jun 2, 2026
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol