Long-term KarXT safety for manic episodes in bipolar I (BALSAM-3)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BALSAM-3 is an open-label, phase 3 extension that enrolls participants who completed prior double-blind KarXT parent studies as well as new participants meeting DSM-5-TR criteria for bipolar I with mania or mixed features. Participants receive KarXT, with concomitant mood stabilizers such as lithium, valproate, or lamotrigine allowed per protocol, and are followed long-term for safety and tolerability outcomes. De novo enrollees must have a confirmed diagnosis via the MINI and meet symptom thresholds (YMRS ≥14 and CGI-BP ≥3) while not requiring hospitalization for acute mania. Safety monitoring includes regular clinical assessments and adverse event reporting across U.S. sites in Arizona and Arkansas.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pillar Clinical Research - Richardson
  Bentonville, Arkansas, United States Recruiting
• Pillar Clinical Research- Little Rock
  Little Rock, Arkansas, United States Recruiting
• Woodland International Research Group
  Little Rock, Arkansas, United States Recruiting
• Woodland Research Northwest
  Rogers, Arkansas, United States Recruiting
• Advanced Research Center Inc.
  Anaheim, California, United States Recruiting
• Clinical Innovations, Inc. dba CITrials
  Bellflower, California, United States Recruiting

+134 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• KarXT for manic episodes in Bipolar I disorder

  This trial will test whether KarXT can reduce manic symptoms in adults hospitalized for an acute manic episode of Bipolar I disorder during a three-week inpatient treatment period.

  Recruiting at 59 sites Phase 3 Bristol-Myers Squibb · Bentonville, Arkansas and 73 other locations · NCT06951698

• KarXT for treating manic episodes in bipolar I disorder (BALSAM-2)

  This trial tests whether KarXT helps adults hospitalized for an acute manic episode of bipolar I disorder (including mixed features) compared with placebo during a 3-week inpatient treatment.

  Recruiting at 57 sites Phase 3 Bristol-Myers Squibb · Little Rock, Arkansas and 85 other locations · NCT06951711

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.