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

Recruiting now · Phase 3

Conditions studied: Bipolar Disorder Type I With Mania

In brief

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.

Key facts

Study ID

NCT06929273

Run by

Bristol-Myers Squibb

People needed

450

Starts

2025-07-18

Expected to finish

2028-06-13

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.
• Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
• Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
• Participants does not require hospitalization for acute mania.

You may not qualify if…

• All participants:
• 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):
• Discontinuation from any KarXT parent studies.
• De novo participants who did not participate in double-blind placebo-controlled studies:
• Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
• 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.
• 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.
• Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
• 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.

Where it is running

• Synexus Clinical Research US, Inc. — Atlanta, Georgia, United States (enrolling)
• Pillar Clinical Research- Little Rock — Little Rock, Arkansas, United States (enrolling)
• South Florida Research Phase I-IV — Miami Springs, Florida, United States (enrolling)
• Health Synergy Clinical Research — West Palm Beach, Florida, United States (enrolling)
• Advanced Research Center Inc. — Anaheim, California, United States (enrolling)
• Clinical Innovations, Inc. dba CITrials — Bellflower, California, United States (enrolling)
• Pillar Clinical Research - Richardson — Bentonville, Arkansas, United States (enrolling)
• Inland Psychiatric Medical Group - Chino — Chino, California, United States (enrolling)
• Woodland Research Northwest — Rogers, Arkansas, United States (enrolling)
• Collaborative Neuroscience Research, LLC — Garden Grove, California, United States (enrolling)
• Omega Clinical Trials - La Habra — La Habra, California, United States (enrolling)
• Catalina Research Institute, LLC — Montclair, California, United States (enrolling)
• NRC Research Institute — Orange, California, United States (enrolling)
• Clinical Innovations, Inc. dba CITrials — Riverside, California, United States (enrolling)
• Woodland International Research Group — Little Rock, Arkansas, United States (enrolling)
• Collaborative Neuroscience Research, LLC — Torrance, California, United States (enrolling)
• Yale New Haven Hospital-Smilow Cancer Center — New Haven, Connecticut, United States (enrolling)
• Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States (enrolling)
• Proscience Research Group — Culver City, California, United States (enrolling)
• Behavioral Clinical Research — Hollywood, Florida, United States (enrolling)
• Research Centers of America ( Hollywood ) — Hollywood, Florida, United States (enrolling)
• LCC Medical Research Institute — Miami, Florida, United States (enrolling)
• Advanced Research Institute of Miami — Miami, Florida, United States (enrolling)
• Innovative Clinical Research, Inc. — Miami Lakes, Florida, United States (enrolling)
• Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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