A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

June 3, 2026 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.

The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

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

Study Locations

  • Croatia
      • Zagreb, Croatia, 10090
        • Recruiting
        • Klinika za psihijatriju "Vrapče"
        • Contact:
          • Marko Curkovic, Site 0078
          • Phone Number: 385951648446
      • Zagreb, Croatia, 10090
        • Recruiting
        • Psihijatrijska bolnica "Sveti Ivan"
        • Contact:
          • Igor Filipcic, Site 0010
          • Phone Number: 38513430020
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10090
        • Withdrawn
        • Local Institution - 0009
  • India
    • Gujarat
      • Vadodara, Gujarat, India, 390021
        • Not yet recruiting
        • Local Institution - 0065
        • Contact:
          • Site 0065
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Not yet recruiting
        • Local Institution - 0082
        • Contact:
          • Site 0082
    • Kerala
      • Kozhikode, Kerala, India, 673009
        • Recruiting
        • Chethana Center for Neuropsychiatry
        • Contact:
          • SURESHKUMAR N, Site 0053
          • Phone Number: 9447218825
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Not yet recruiting
        • Local Institution - 0051
        • Contact:
          • Site 0051
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Not yet recruiting
        • Local Institution - 0055
        • Contact:
          • Site 0055
      • Hyderabad, Telangana, India, 500034
        • Recruiting
        • Asha Hospital - Hyderabad
        • Contact:
          • G Rao, Site 0052
          • Phone Number: 9985900005
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Recruiting
        • Nil Ratan Sircar Medical College and Hospital
        • Contact:
          • Asish Mukhopadhyay, Site 0054
          • Phone Number: 8250737511
      • Kolkata, West Bengal, India, 700025
        • Not yet recruiting
        • Local Institution - 0096
        • Contact:
          • Site 0096
  • Israel
      • Jerusalem, Israel, 9546105
        • Recruiting
        • Kfar Shaul Mental Health Center
        • Contact:
          • Alexander Teitelbaum, Site 0045
          • Phone Number: +972-506262005
    • Central District
      • Hod HaSharon, Central District, Israel, 4534708
        • Recruiting
        • Shalvata Mental Health Center
        • Contact:
          • Yuri Fonar, Site 0042
          • Phone Number: +972545838725
      • Ness Ziona, Central District, Israel, 7410001
        • Recruiting
        • Ness Ziona Mental Health Center
        • Contact:
          • Marina Kupchik, Site 0046
          • Phone Number: +972506261093
      • Petah Tikva, Central District, Israel, 4910002
        • Not yet recruiting
        • Local Institution - 0058
        • Contact:
          • Site 0058
      • Ramat Gan, Central District, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Linda Levi-Haramati, Site 0011
          • Phone Number: 0585950299
    • Southern District
      • Beersheba, Southern District, Israel, 8461144
        • Recruiting
        • Be'er Sheva Mental Health Center
        • Contact:
          • Yuly Bersudsky, Site 0066
          • Phone Number: 972-8-6401463
  • Italy
      • Ancona, Italy, 60126
        • Withdrawn
        • Local Institution - 0041
      • Genova, Italy, 16132
        • Withdrawn
        • Local Institution - 0040
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Withdrawn
        • Local Institution - 0001
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Withdrawn
        • Local Institution - 0056
      • Siena, Tuscany, Italy, 53100
        • Withdrawn
        • Local Institution - 0007
  • Romania
      • Bucharest, Romania, 060222
        • Recruiting
        • Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
        • Contact:
          • Traian Barbu, Site 0064
          • Phone Number: +40723652564
      • Bucharest, Romania
        • Recruiting
        • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
        • Contact:
          • Octavian Vasiliu, Site 0057
          • Phone Number: 0040723725815
      • Iași, Romania, 700282
        • Not yet recruiting
        • Local Institution - 0047
        • Contact:
          • Site 0047
      • Sanpetru /Brasov, Romania, 507190
        • Recruiting
        • Spitalul de Psihiatrie si Neurologie Brasov
        • Contact:
          • Petru Ifteni, Site 0061
          • Phone Number: 0040724993329
    • Bucharest
      • Bucharest, Bucharest, Romania, 041914
        • Recruiting
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
        • Contact:
          • Laura Cristina Dolis, Site 0062
          • Phone Number: 0040757243543
  • Slovakia
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 01
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
      • Košice, Košice Region, Slovakia, 040 01
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
    • Presov
      • Vranov nad Topľou, Presov, Slovakia, 093 01
        • Not yet recruiting
        • Local Institution - 0072
        • Contact:
          • Site 0072
  • Spain
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Josep Antoni Ramos-Quiroga, Site 0069
          • Phone Number: +34934894295
    • Basque Country
      • Bilbao, Basque Country, Spain, 48013
        • Recruiting
        • Osi Bilbao-Basurto
        • Contact:
          • Ana Catalan, Site 0039
          • Phone Number: 669736802
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Eduard Vieta, Site 0044
          • Phone Number: 932275400
  • Sweden
    • Stockholms Län [se-01]
      • Nacka, Stockholms Län [se-01], Sweden, 131 45
        • Recruiting
        • Nacka Local Hospital
        • Contact:
          • Andreas Carlborg, Site 0077
          • Phone Number: +46(0)8-12341043
    • Uppsala Län [se-03]
      • Uppsala, Uppsala Län [se-03], Sweden, 751 85
        • Withdrawn
        • Local Institution - 0067
    • Västra Götalands Län [se-14]
      • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
        • Withdrawn
        • Local Institution - 0070
  • Ukraine
      • Kropyvnytskyi, Ukraine, 25491
        • Not yet recruiting
        • Local Institution - 0084
        • Contact:
          • Site 0084
      • Odesa, Ukraine, 65006
        • Not yet recruiting
        • Local Institution - 0094
        • Contact:
          • Site 0094
      • Poltava, Ukraine, 36013
        • Not yet recruiting
        • Local Institution - 0090
        • Contact:
          • Site 0090
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49115
        • Not yet recruiting
        • Local Institution - 0088
        • Contact:
          • Site 0088
    • Kyivska Oblast
      • Hlevakha, Kyivska Oblast, Ukraine, 08631
        • Not yet recruiting
        • Local Institution - 0092
        • Contact:
          • Site 0092
    • Odesa Oblast
      • Oleksandrivka, Odesa Oblast, Ukraine, 67513
        • Not yet recruiting
        • Local Institution - 0093
        • Contact:
          • Site 0093
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Pillar Clinical Research- Little Rock
        • Contact:
          • Leslie Smith, Site 0014
          • Phone Number: 501-350-3285
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Woodland Research Northwest
        • Contact:
          • Robert Billingsley, Site 0025
          • Phone Number: 479-927-3000
    • California
      • Culver City, California, United States, 90230
        • Recruiting
        • ProScience Research Group
        • Contact:
          • Marina Bussel, Site 0021
          • Phone Number: 424-227-8127
      • Riverside, California, United States, 92506
        • Recruiting
        • Clinical Innovations, Inc. dba CITrials
        • Contact:
          • Evagelos Coskinas, Site 0018
          • Phone Number: 951300492
      • Torrance, California, United States, 90502
        • Recruiting
        • Collaborative Neuroscience Research, LLC
        • Contact:
          • Lara Shirikjian, Site 0074
          • Phone Number: 310-523-4200
    • Florida
      • Hialeah Gardens, Florida, United States, 33016
        • Withdrawn
        • Local Institution - 0036
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Behavioral Clinical Research
        • Contact:
          • Olga Lapeyra, Site 0032
          • Phone Number: 954-375-7794
      • Miami, Florida, United States, 33126
        • Recruiting
        • LCC Medical Research Institute
        • Contact:
          • Yesenia Kuan, Site 0026
          • Phone Number: 305-400-0814
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Innovative Clinical Research, Inc.
        • Contact:
          • Rishi Kakar, Site 0081
          • Phone Number: 786-512-4106
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • South Florida Research Phase I-IV
        • Contact:
          • Silvia Silva Duluc, Site 0015
          • Phone Number: 305-669-6166
      • Tampa, Florida, United States, 33618
        • Withdrawn
        • Local Institution - 0019
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Health Synergy Clinical Research
        • Contact:
          • Mohammad Nisar, Site 0083
          • Phone Number: 786-831-7303
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
        • Contact:
          • Elyssa Barron, Site 0022
          • Phone Number: 404-881-5800
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Kimball Johnson, Site 0016
          • Phone Number: 404-537-1281
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Recruiting
        • CBH Health
        • Contact:
          • Elia Acevedo Diaz, Site 0024
          • Phone Number: 301-251-4702
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Precise Research Centers
        • Contact:
          • Joseph Kwentus, Site 0017
          • Phone Number: 601-420-5810
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Arch Clinical Trials
        • Contact:
          • Junaid Syed, Site 0023
          • Phone Number: 314-771-6387
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Withdrawn
        • Local Institution - 0076
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Hassman Research Institute Marlton Site
        • Contact:
          • Elan Cohen, Site 0080
          • Phone Number: 267-981-8911
      • Marlton, New Jersey, United States, 08053
        • Withdrawn
        • Local Institution - 0031
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Withdrawn
        • Local Institution - 0075
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Caleb Adler, Site 0029
          • Phone Number: 513-404-0279
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro-Behavioral Clinical Research
        • Contact:
          • Shishuka Malhotra, Site 0038
          • Phone Number: 330-493-1118
    • Texas
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • InSite Clinical Research
        • Contact:
          • Rajinder Shiwach, Site 0012
          • Phone Number: 972-283-6286
      • Houston, Texas, United States, 77021
        • Withdrawn
        • Local Institution - 0028
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Pillar Clinical Research - Richardson
        • Contact:
          • Scott Bartley, Site 0037
          • Phone Number: 214-396-4844
      • Richardson, Texas, United States, 75080
        • Not yet recruiting
        • Local Institution - 0095
        • Contact:
          • Site 0095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
  • Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
  • Participants must require hospitalization for the acute exacerbation or relapse of mania.
  • Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
  • 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.

Exclusion Criteria:

  • 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, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
  • Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
  • 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 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).
  • Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Experimental: KarXT
Flexible dosing
Drug: KarXT
Specified dose on specified days
Other Names:
  • BMS-986510
  • Xanomeline and trospium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Young Mania Rating Scale (YMRS) score
Time Frame: At week 3
The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity.
At week 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)
Time Frame: At week 3
The CGI-BP is designed to assess the severity, improvement, and efficacy of treatment in individuals with bipolar disorder. Only section I, illness severity, will be used, which includes three components: mania, depression, and overall bipolar illness. The ratings are on a 7-point scale (1 = normal, not ill; 2 = minimally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = very severely ill).
At week 3
Occurrence of response based on ≥ 50% decrease from baseline in YMRS score or total score
Time Frame: At week 3
At week 3
Occurrence of response based on change from baseline ≥ 1 in CGI-BP
Time Frame: At week 3
At week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

November 2, 2026

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0037
  • 2024-520195-94 (Other Identifier: EU CTR)
  • U1111-1316-7466 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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