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Study identifier: NCT06929273 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Bipolar Disorder Type I With Mania  ·  Sponsor: Bristol-Myers Squibb

PhasePhase 3
Planned participants450
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com  ·  855-907-3286  ·  Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Always discuss trial participation with your own doctor first.

Locations (174)

Local Institution - 0120Glendale, Arizona, United StatesNot Yet Recruiting
Pillar Clinical Research - RichardsonBentonville, Arkansas, United StatesRecruiting
Pillar Clinical Research- Little RockLittle Rock, Arkansas, United StatesRecruiting
Woodland International Research GroupLittle Rock, Arkansas, United StatesRecruiting
Woodland Research NorthwestRogers, Arkansas, United StatesRecruiting
Advanced Research Center Inc.Anaheim, California, United StatesRecruiting
Clinical Innovations, Inc. dba CITrialsBellflower, California, United StatesRecruiting
Local Institution - 0044Cerritos, California, United StatesNot Yet Recruiting
Inland Psychiatric Medical Group - ChinoChino, California, United StatesRecruiting
Proscience Research GroupCulver City, California, United StatesRecruiting
Collaborative Neuroscience Research, LLCGarden Grove, California, United StatesRecruiting
Omega Clinical Trials - La HabraLa Habra, California, United StatesRecruiting

+ 162 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06929273