drugset / Trial / NCT06929273
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-07-18
- Primary completion
- 2028-06-13
- Completion
- 2028-06-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trospium | Small molecule | — | — |
| Subject | Xanomeline | Small molecule | — | — |
| Background | Lamotrigine | Small molecule | — | — |
| Background | Lithium | Unknown | — | — |
| Background | Valproate | Small molecule | — | — |