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

U.S., April 17 -- ClinicalTrials.gov registry received information related to the study (NCT06929273) titled 'A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)' on April 14.

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.

Study Start Date: July 22, 2025

Study Type: INTERVENTIONAL

Condition: Bipolar Disorder Type I With Mania

Intervention: DRUG...