A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
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 (BALSAM-3)
3 other identifiers
interventional
450
20 countries
173
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
Typical duration for phase_3
173 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2025
CompletedFirst Posted
Study publicly available on registry
April 16, 2025
CompletedStudy Start
First participant enrolled
July 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 13, 2028
June 2, 2026
June 1, 2026
2.9 years
April 14, 2025
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment emergent adverse events (TEAEs)
Up to week 54
Secondary Outcomes (8)
Number of participants with AEs of special interest (AESIs)
Up to week 54
Number of participants with serious AEs (SAEs)
Up to week 54
Number of participants with TEAEs leading to treatment discontinuation
Up to week 52
Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to week 54
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
Up to week 54
- +3 more secondary outcomes
Study Arms (1)
KarXT or Adjuvant KarXT
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
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:
- Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):
- a. Discontinuation from any KarXT parent studies.
- De novo participants who did not participate in double-blind placebo-controlled studies:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (173)
Local Institution - 0120
Glendale, Arizona, 85304, United States
Pillar Clinical Research - Richardson
Bentonville, Arkansas, 72712, United States
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, 72204, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Woodland Research Northwest
Rogers, Arkansas, 72758, United States
Advanced Research Center Inc.
Anaheim, California, 92805, United States
Clinical Innovations, Inc. dba CITrials
Bellflower, California, 90706, United States
Local Institution - 0044
Cerritos, California, 90703, United States
Inland Psychiatric Medical Group - Chino
Chino, California, 91710, United States
Proscience Research Group
Culver City, California, 90230, United States
Collaborative Neuroscience Research, LLC
Garden Grove, California, 92845-2506, United States
Omega Clinical Trials - La Habra
La Habra, California, 90631, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
NRC Research Institute
Orange, California, 92868, United States
Clinical Innovations, Inc. dba CITrials
Riverside, California, 92506, United States
Local Institution - 0136
Santa Ana, California, 92705, United States
Collaborative Neuroscience Research, LLC
Torrance, California, 90504, United States
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, 06510, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Local Institution - 0026
Hialeah Gardens, Florida, 33016, United States
Behavioral Clinical Research
Hollywood, Florida, 33021, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024, United States
LCC Medical Research Institute
Miami, Florida, 33126, United States
Advanced Research Institute of Miami
Miami, Florida, 33135, United States
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016, United States
South Florida Research Phase I-IV
Miami Springs, Florida, 33166, United States
Local Institution - 0045
St. Petersburg, Florida, 33713, United States
Health Synergy Clinical Research
West Palm Beach, Florida, 33407, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
CenExel iResearch, LLC
Savannah, Georgia, 31405, United States
Local Institution - 0031
Chicago, Illinois, 60640, United States
Pillar Clinical Research -Chicago
Chicago, Illinois, 60641, United States
CBH Health
Gaithersburg, Maryland, 20877, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Arch Clinical Trials
St Louis, Missouri, 63141, United States
Local Institution - 0121
North Las Vegas, Nevada, 89030, United States
Local Institution - 0122
North Las Vegas, Nevada, 89030, United States
Hassman Research Institute Marlton Site
Marlton, New Jersey, 08053, United States
Local Institution - 0058
Marlton, New Jersey, 08053, United States
Richmond Behavioral Associates
Staten Island, New York, 10314, United States
Local Institution - 0124
Charlotte, North Carolina, 28211, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720, United States
Community Clinical Research
Austin, Texas, 78754, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Local Institution - 0046
Houston, Texas, 77021, United States
Elevate Clinical Research-Houston
Houston, Texas, 77058, United States
Local Institution - 0036
Irving, Texas, 75062, United States
Prime Clinical Research - Mansfield
Mansfield, Texas, 76063, United States
Pillar Clinical Research - Richardson
Richardson, Texas, 75080, United States
Local Institution - 0128
ABB, Buenos Aires F.D., C1199ABB, Argentina
Local Institution - 0127
Córdoba, 5000, Argentina
Local Institution - 0126
Mendoza, 5502, Argentina
Ramsay Clinic Northside
St Leonards, New South Wales, 2065, Australia
Ramsay Clinic New Farm
Brisbane, Queensland, 4005, Australia
Center for Mental Health Prof. Dr. Ivan Temkov
Burgas, 8001, Bulgaria
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
Novi Iskar, 1282, Bulgaria
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, 5800, Bulgaria
MHAT "Dr. Ival Seliminski"
Sliven, 8800, Bulgaria
Mental Health Center - Vratsa
Vratsa, 3000, Bulgaria
Local Institution - 0177
Beijing, Beijing Municipality, 100088, China
Local Institution - 0174
Beijing, Beijing Municipality, 100096, China
Local Institution - 0175
Guangzhou, Guangdong, 510370, China
Local Institution - 0181
Baoding, Hebei, 71000, China
Local Institution - 0185
Shijiazhuang, Hebei, 050031, China
Local Institution - 0184
Changsha, Hunan, 410011, China
Local Institution - 0180
Nanjing, Jiangsu, 210029, China
Local Institution - 0176
Xi'an, Shaanxi, 710061, China
Local Institution - 0179
Chengdu, Sichuan, 610036, China
Local Institution - 0183
Tianjin, Tianjin Municipality, 300022, China
Local Institution - 0182
Ningbo, Zhejiang, 315201, China
Local Institution - 0018
Zagreb, City of Zagreb, 10090, Croatia
Klinika za psihijatriju "Vrapče"
Zagreb, 10090, Croatia
Klinika za psihijatriju "Vrapče"
Zagreb, 10090, Croatia
Klinika za psihijatriju "Vrapče"
Zagreb, 10090, Croatia
Psihijatrijska bolnica "Sveti Ivan"
Zagreb, 10090, Croatia
Local Institution - 0153
Aalborg, North Denmark, 9000, Denmark
Local Institution - 0154
Glostrup Municipality, 2600, Denmark
Local Institution - 0170
Nice, Alpes-Maritimes, 06000, France
Local Institution - 0171
Clermont-Ferrand, 63000, France
Local Institution - 0172
Montpellier, 34295, France
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, 9024, Hungary
Local Institution - 0110
Budapest, 0, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Local Institution - 0111
Vadodara, Gujarat, 390021, India
Local Institution - 0132
Belagavi, Karnataka, 590010, India
Local Institution - 0159
Mangalore, Karnataka, 575003, India
Local Institution - 0190
Mangaluru, Karnataka, 574143, India
Local Institution - 0079
Kozhikode, Kerala, 673009, India
Local Institution - 0077
Ludhiana, Punjab, 141001, India
Local Institution - 0158
Madurai, Tamil Nadu, 625020, India
Local Institution - 0078
Hyderabad, Telangana, 500034, India
Local Institution - 0080
Hyderabad, Telangana, 500082, India
Local Institution - 0076
Kolkata, West Bengal, 700014, India
Local Institution - 0160
Kolkata, West Bengal, 700025, India
Shalvata Mental Health Center
Hod HaSharon, Central District, 4534708, Israel
Ness Ziona Mental Health Center
Ness Ziona, Central District, 7410001, Israel
Local Institution - 0084
Petah Tikva, Central District, 4910002, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Be'er Sheva Mental Health Center
Beersheba, Southern District, 8461144, Israel
Local Institution - 0173
Ashkelon, 78306, Israel
Local Institution - 0187
Bnei Brak, 5154475, Israel
Local Institution - 0168
Jerusalem, 91120, Israel
Kfar Shaul Mental Health Center
Jerusalem, 9546105, Israel
Local Institution - 0066
Milan, Lombardy, 20122, Italy
Local Institution - 0083
Pisa, Tuscany, 56126, Italy
Local Institution - 0065
Siena, Tuscany, 53100, Italy
Local Institution - 0070
Ancona, 60126, Italy
Local Institution - 0069
Genova, 16132, Italy
Hotei Hospital
Kōnan, Aichi-ken, 4838248, Japan
Okehazama Hospital
Toyoake, Aichi-ken, 470-1168, Japan
National Kohnodai Medical Center.
Ichikawa, Chiba, 272-8516, Japan
Local Institution - 0166
Iizuka, Fukuoka, 820-8505, Japan
Local Institution - 0063
Kitakyushu, Fukuoka, 803-0831, Japan
Obihiro Kosei Hospital
Obihiro, Hokkaido, 080-0024, Japan
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, 002-8029, Japan
Local Institution - 0165
Yokohama, Kanagawa, 234-0051, Japan
Kansai Medical University Medical Center
Moriguchi, Osaka, 570-8507, Japan
Local Institution - 0007
Sakai-shi, Osaka, 590-0018, Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, 847-0031, Japan
Local Institution - 0016
Iruma, Saitama, 350-0495, Japan
Saitama Konan Hospital
Kumagaya, Saitama, 360-0114, Japan
Local Institution - 0163
Bunkyo-ku, Tokyo, 113-8431, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 1138603, Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551, Japan
Narimasu Kosei Hospital
tabashi City, Tokyo, 175-0091, Japan
Kuramitsu Hospital
Fukuoka, 819-0037, Japan
Kochi Health Sciences Center
Kochi, 781-8555, Japan
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, 880-8510, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Showa Medical University Karasuyama Hospital
Tokyo, 157-8577, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Yamagata Sakuracho Hospital
Yamagata, 990-0045, Japan
North Shore Hospital
Auckland, 0622, New Zealand
Centrum Medyczne HCP
Poznan, Greater Poland Voivodeship, 61-485, Poland
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, 02-957, Poland
Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
Bialystok, Podlaskie Voivodeship, 15-272, Poland
Local Institution - 0093
Gdansk, Pomeranian Voivodeship, 80-214, Poland
M2M Med
Rybnik, Silesian Voivodeship, 44-200, Poland
Clinica Inventiva
Tuszyn, 95-080, Poland
Local Institution - 0095
Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914, Romania
Local Institution - 0167
Bucharest, 011241, Romania
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Bucharest, 060222, Romania
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
Bucharest, 0, Romania
Local Institution - 0097
Iași, 700282, Romania
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, 507190, Romania
Local Institution - 0118
Košice, Košice Region, 040 01, Slovakia
Local Institution - 0119
Košice, Košice Region, 040 01, Slovakia
Local Institution - 0117
Vranov nad Topľou, Presov, 093 01, Slovakia
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
Osi Bilbao-Basurto
Bilbao, Basque Country, 48013, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], 08036, Spain
Nacka Local Hospital
Nacka, Stockholms Län [se-01], 131 45, Sweden
Local Institution - 0112
Uppsala, Uppsala Län [se-03], 751 85, Sweden
Local Institution - 0116
Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden
Local Institution - 0152
Smila, Cherkasy Oblast, 20708, Ukraine
Local Institution - 0146
Skarzhyntsi, Khmelnytskyi Oblast, 32120, Ukraine
Local Institution - 0143
Hlevakha, Kyivska Oblast, 08631, Ukraine
Local Institution - 0147
Lviv, Lviv Oblast, 79021, Ukraine
Local Institution - 0145
Oleksandrivka, Odesa Oblast, 67513, Ukraine
Local Institution - 0189
Ternopil, Ternopil Oblast, 460027, Ukraine
Local Institution - 0148
Vinnytsia, Vinnytsia Oblast, 21037, Ukraine
Local Institution - 0149
Dnipro, 49115, Ukraine
Local Institution - 0151
Kropyvnytskyi, 25491, Ukraine
Local Institution - 0150
Kyiv, 04080, Ukraine
Local Institution - 0141
Poltava, 36013, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2025
First Posted
April 16, 2025
Study Start
July 18, 2025
Primary Completion (Estimated)
June 13, 2028
Study Completion (Estimated)
June 13, 2028
Last Updated
June 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See 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