KarXT for Mania

(BALSAM-1 Trial)

Recruiting at 60 trial locations

Overseen By BMS Study Connect www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Psychotropics

Disqualifiers: Substance use disorder, Suicidal risk, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

274 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking all psychotropic medications (drugs that affect mood, perception, or behavior) at least 14 days before starting the trial medication.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with Bipolar-I Disorder experiencing a manic or mixed episode requiring hospitalization. They must score ≥20 on the YMRS, have a CGI-BP of ≥4, and be off psychotropic meds for up to 14 days before starting the study drug. Exclusions include substance use disorders within the last year (except tobacco), other primary DSM-5-TR diagnoses, high suicide risk, urinary or gastric retention risks, rapid cycling bipolar disorder, and recent serious constipation issues.

Inclusion Criteria

Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline

Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline

I am currently having a manic episode or mixed features lasting no more than 3 weeks.

Exclusion Criteria

Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test

Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders

Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KarXT or placebo during a 3-week inpatient period to evaluate efficacy in treating manic episodes

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• KarXT

Trial Overview The trial is testing KarXT against a placebo to see how well it works and how safe it is in treating manic episodes in Bipolar-I Disorder patients. Participants will either receive KarXT or an inactive pill without knowing which one they are taking.

Participant Groups

Group I: KarXT Experimental Treatment 1 Intervention

Flexible dosing

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania