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RECRUITING

NCT06929273

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2025-07-18

Completion Date

2028-06-13

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Bipolar Disorder Type I With Mania

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

Lithium

Therapeutic dose

DRUG

Valproate

Therapeutic dose

DRUG

Lamotrigine

Therapeutic dose

Inclusion Criteria: * Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): a. Participants must have completed treatment period of parent study. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania. 2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline. 3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline. 4. Participants does not require hospitalization for acute mania. Exclusion Criteria: * All participants: 1\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS. * Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): 1\. Discontinuation from any KarXT parent studies. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year). 2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. 3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test. 4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. 5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (184)

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Little Rock, Arkansas, United States

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Rogers, Arkansas, United States

Advanced Research Center Inc.

Anaheim, California, United States

Clinical Innovations, Inc. dba CITrials

Bellflower, California, United States

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Chino, California, United States

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Culver City, California, United States

Collaborative Neuroscience Research, LLC

Garden Grove, California, United States

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La Habra, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

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Northridge, California, United States

NRC Research Institute

Orange, California, United States

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Riverside, California, United States

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Santa Ana, California, United States

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Torrance, California, United States

Yale New Haven Hospital-Smilow Cancer Center

New Haven, Connecticut, United States

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Hallandale, Florida, United States

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Hialeah Gardens, Florida, United States

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Hollywood, Florida, United States

Research Centers of America ( Hollywood )

Hollywood, Florida, United States

LCC Medical Research Institute

Miami, Florida, United States

Advanced Research Institute of Miami

Miami, Florida, United States

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Miami Lakes, Florida, United States

South Florida Research Phase I-IV

Miami Springs, Florida, United States

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St. Petersburg, Florida, United States

Synexus Clinical Research US, Inc.

Atlanta, Georgia, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

CenExel iResearch, LLC

Savannah, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Lincoln, Nebraska, United States

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North Las Vegas, Nevada, United States

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North Las Vegas, Nevada, United States

Hassman Research Institute Marlton Site

Marlton, New Jersey, United States

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Marlton, New Jersey, United States

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Staten Island, New York, United States

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Charlotte, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

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West Chester, Ohio, United States

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Carrollton, Texas, United States

Adams Clinical Dallas

DeSoto, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

Prime Clinical Research - Mansfield

Mansfield, Texas, United States

Pillar Clinical Research - Richardson

Richardson, Texas, United States

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Wichita Falls, Texas, United States

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ABB, Buenos Aires F.D., Argentina

Sanatorio Morra S.A.

Córdoba, Argentina

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Mendoza, Argentina

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Santiago del Estero, Argentina

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St Leonards, New South Wales, Australia

Ramsay Clinic New Farm

Brisbane, Queensland, Australia

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Kazanlak, Stara Zagora, Bulgaria

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Burgas, Bulgaria

Center for Mental Health - Haskovo

Haskovo, Bulgaria

State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar

Novi Iskar, Bulgaria

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Pleven, Bulgaria

MHAT "Dr. Ival Seliminski"

Sliven, Bulgaria

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Sofia, Bulgaria

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Vratsa, Bulgaria

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Zagreb, Croatia

Psihijatrijska bolnica "Sveti Ivan"

Zagreb, Croatia

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Gistrup, Denmark

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Glostrup Municipality, Denmark

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Chu Gabriel Montpied

Clermont-Ferrand, Puy-de-Dôme, France

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Montpellier, France

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

Semmelweis Egyetem

Budapest, Hungary

Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet

Budapest, Hungary

GMERS Medical College and General Hospital

Vadodara, Gujarat, India

KLES Dr. Prabhakar Kore Hospital & M.R.C

Belagavi, Karnataka, India

And 84 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (184)