A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
NCT ID: NCT06951711
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
274 participants
INTERVENTIONAL
2025-06-13
2026-11-02
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KarXT
Flexible dosing
KarXT
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Proscience Research Group
Culver City, California, United States
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States
Collaborative Neuroscience Research, LLC
Torrance, California, United States
Local Institution - 0036
Hialeah Gardens, Florida, United States
Behavioral Clinical Research
Hollywood, Florida, United States
LCC Medical Research Institute
Miami, Florida, United States
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States
South Florida Research Phase I-IV
Miami Springs, Florida, United States
Local Institution - 0083
Okeechobee, Florida, United States
Local Institution - 0019
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Local Institution - 0020
Chicago, Illinois, United States
CBH Health
Gaithersburg, Maryland, United States
Local Institution - 0017
Flowood, Mississippi, United States
Arch Clinical Trials
St Louis, Missouri, United States
Local Institution - 0076
North Las Vegas, Nevada, United States
Hassman Research Institute Marlton Site
Marlton, New Jersey, United States
Local Institution - 0031
Marlton, New Jersey, United States
Local Institution - 0075
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States
InSite Clinical Research
DeSoto, Texas, United States
Local Institution - 0028
Houston, Texas, United States
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Local Institution - 0009
Zagreb, City of Zagreb, Croatia
Local Institution - 0008
Zagreb, , Croatia
Local Institution - 0010
Zagreb, , Croatia
Local Institution - 0063
Zagreb, , Croatia
Local Institution - 0078
Zagreb, , Croatia
Local Institution - 0065
Vadodara, Gujarat, India
Local Institution - 0082
Belagavi, Karnataka, India
Local Institution - 0053
Kozhikode, Kerala, India
Local Institution - 0051
Ludhiana, Punjab, India
Local Institution - 0052
Hyderabad, Telangana, India
Local Institution - 0055
Hyderabad, Telangana, India
Local Institution - 0054
Kolkata, West Bengal, India
Shalvata Mental Health Center
Hod HaSharon, Central District, Israel
Local Institution - 0046
Ness Ziona, Central District, Israel
Local Institution - 0058
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Be'er Sheva Mental Health Center
Beersheba, Southern District, Israel
Kfar Shaul Mental Health Center
Jerusalem, , Israel
Local Institution - 0001
Milan, Lombardy, Italy
Local Institution - 0056
Pisa, Tuscany, Italy
Local Institution - 0007
Siena, Tuscany, Italy
Local Institution - 0041
Ancona, , Italy
Local Institution - 0040
Genova, , Italy
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Bucharest, , Romania
Local Institution - 0057
Bucharest, , Romania
Local Institution - 0047
Iași, , Romania
Local Institution - 0061
Sanpetru /Brasov, , Romania
Local Institution - 0071
Košice, Košice Region, Slovakia
Local Institution - 0073
Košice, Košice Region, Slovakia
Local Institution - 0072
Vranov nad Topľou, Presov, Slovakia
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Osi Bilbao-Basurto
Bilbao, Basque Country, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Nacka Local Hospital
Nacka, Stockholms Län [se-01], Sweden
Local Institution - 0067
Uppsala, Uppsala Län [se-03], Sweden
Local Institution - 0070
Gothenburg, Västra Götalands Län [se-14], Sweden
Countries
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Central Contacts
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BMS Study Connect www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Leslie Smith, Site 0014
Role: primary
Robert Billingsley, Site 0025
Role: primary
Marina Bussel, Site 0021
Role: primary
Evagelos Coskinas, Site 0018
Role: primary
Lara Shirikjian, Site 0074
Role: primary
Olga Lapeyra, Site 0032
Role: primary
Yesenia Kuan, Site 0026
Role: primary
Rishi Kakar, Site 0081
Role: primary
Silvia Silva Duluc, Site 0015
Role: primary
Site 0083
Role: primary
Elyssa Barron, Site 0022
Role: primary
Kimball Johnson, Site 0016
Role: primary
Site 0020
Role: primary
Elia Acevedo Diaz, Site 0024
Role: primary
Site 0017
Role: primary
Junaid Syed, Site 0023
Role: primary
Elan Cohen, Site 0080
Role: primary
Site 0075
Role: primary
Caleb Adler, Site 0029
Role: primary
Shishuka Malhotra, Site 0038
Role: primary
SURESH SUREDDI, Site 0012
Role: primary
Site 0028
Role: primary
Scott Bartley, Site 0037
Role: primary
Site 0008
Role: primary
Site 0010
Role: primary
Site 0063
Role: primary
Site 0078
Role: primary
Site 0065
Role: primary
Site 0082
Role: primary
Site 0053
Role: primary
Site 0051
Role: primary
Site 0052
Role: primary
Site 0055
Role: primary
Site 0054
Role: primary
Yuri Fonar, Site 0042
Role: primary
Site 0046
Role: primary
Site 0058
Role: primary
Mark Weiser, Site 0011
Role: primary
Yuly Bersudsky, Site 0066
Role: primary
Alexander Teitelbaum, Site 0045
Role: primary
Valentin Matei, Site 0048
Role: primary
Corina Nicolae, Site 0059
Role: primary
SIMONA TRIFU, Site 0049
Role: primary
Mihnea Manea, Site 0060
Role: primary
ADELA CIOBANU, Site 0050
Role: primary
Laura Cristina Dolis, Site 0062
Role: primary
Traian Barbu, Site 0064
Role: primary
Site 0057
Role: primary
Site 0047
Role: primary
Site 0061
Role: primary
Site 0071
Role: primary
Site 0073
Role: primary
Site 0072
Role: primary
Josep Antoni Ramos-Quiroga, Site 0069
Role: primary
Ana Catalan, Site 0039
Role: primary
Eduard Vieta, Site 0044
Role: primary
Andreas Carlborg, Site 0077
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-520195-94
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1316-7466
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0037
Identifier Type: -
Identifier Source: org_study_id