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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06929273

Public ClinicalTrials.gov record NCT06929273. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 9, 2026, 1:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Study identification

NCT ID
NCT06929273
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
450 participants

Conditions and interventions

Interventions

  • KarXT Drug
  • Lamotrigine Drug
  • Lithium Drug
  • Valproate Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 17, 2025
Primary completion
Jun 12, 2028
Completion
Jun 12, 2028
Last update posted
Apr 22, 2026

2025 – 2028

United States locations

U.S. sites
51
U.S. states
16
U.S. cities
43
Facility City State ZIP Site status
Local Institution - 0120 Glendale Arizona 85304 Not yet recruiting
Pillar Clinical Research - Richardson Bentonville Arkansas 72712 Recruiting
Pillar Clinical Research- Little Rock Little Rock Arkansas 72204 Recruiting
Woodland International Research Group Little Rock Arkansas 72211 Recruiting
Woodland Research Northwest Rogers Arkansas 72758 Recruiting
Advanced Research Center Inc. Anaheim California 92805 Recruiting
Clinical Innovations, Inc. dba CITrials Bellflower California 90706 Recruiting
Local Institution - 0044 Cerritos California 90703 Not yet recruiting
Inland Psychiatric Medical Group - Chino Chino California 91710 Recruiting
Proscience Research Group Culver City California 90230 Recruiting
Collaborative Neuroscience Research, LLC Garden Grove California 92845-2506 Recruiting
Omega Clinical Trials - La Habra La Habra California 90631 Recruiting
Catalina Research Institute, LLC Montclair California 91763 Recruiting
NRC Research Institute Orange California 92868 Recruiting
Clinical Innovations, Inc. dba CITrials Riverside California 92506 Recruiting
Collaborative Neuroscience Research, LLC Torrance California 90504 Recruiting
Local Institution - 0131 New Haven Connecticut 06510 Not yet recruiting
Velocity Clinical Research, Hallandale Beach Hallandale Florida 33009 Recruiting
Local Institution - 0026 Hialeah Gardens Florida 33016 Not yet recruiting
Behavioral Clinical Research Hollywood Florida 33021 Recruiting
Research Centers of America ( Hollywood ) Hollywood Florida 33024 Recruiting
LCC Medical Research Institute Miami Florida 33126 Recruiting
Advanced Research Institute of Miami Miami Florida 33135 Recruiting
Innovative Clinical Research, Inc. Miami Lakes Florida 33016 Recruiting
South Florida Research Phase I-IV Miami Springs Florida 33166 Recruiting
Local Institution - 0045 St. Petersburg Florida 33713 Not yet recruiting
Health Synergy Clinical Research West Palm Beach Florida 33407 Recruiting
Synexus Clinical Research US, Inc. Atlanta Georgia 30328 Recruiting
Atlanta Center for Medical Research Atlanta Georgia 30331 Recruiting
CenExel iResearch, LLC Decatur Georgia 30030 Recruiting
CenExel iResearch, LLC Savannah Georgia 31405 Recruiting
Local Institution - 0031 Chicago Illinois 60640 Not yet recruiting
Pillar Clinical Research -Chicago Chicago Illinois 60641 Recruiting
CBH Health Gaithersburg Maryland 20877 Recruiting
Precise Research Centers Flowood Mississippi 39232 Recruiting
Arch Clinical Trials St Louis Missouri 63141 Recruiting
Local Institution - 0121 North Las Vegas Nevada 89030 Not yet recruiting
Local Institution - 0122 North Las Vegas Nevada 89030 Withdrawn
Hassman Research Institute Marlton Site Marlton New Jersey 08053 Recruiting
Local Institution - 0058 Marlton New Jersey 08053 Withdrawn
Richmond Behavioral Associates Staten Island New York 10314 Recruiting
Local Institution - 0124 Charlotte North Carolina 28211 Withdrawn
University of Cincinnati Medical Center Cincinnati Ohio 45219 Recruiting
Neuro-Behavioral Clinical Research North Canton Ohio 44720 Recruiting
Community Clinical Research Austin Texas 78754 Recruiting
InSite Clinical Research DeSoto Texas 75115 Recruiting
Local Institution - 0046 Houston Texas 77021 Withdrawn
Local Institution - 0138 Houston Texas 77058 Not yet recruiting
Local Institution - 0036 Irving Texas 75062 Withdrawn
Prime Clinical Research - Mansfield Mansfield Texas 76063 Recruiting
Pillar Clinical Research - Richardson Richardson Texas 75080 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 114 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06929273, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 22, 2026 · Synced May 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06929273 live on ClinicalTrials.gov.

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