A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

June 1, 2026 updated by: Bristol-Myers Squibb

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

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

  • Argentina
      • Córdoba, Argentina, 5000
        • Not yet recruiting
        • Local Institution - 0127
        • Contact:
          • Site 0127
      • Mendoza, Argentina, 5502
        • Not yet recruiting
        • Local Institution - 0126
        • Contact:
          • Site 0126
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Not yet recruiting
        • Local Institution - 0128
        • Contact:
          • Site 0128
  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Ramsay Clinic Northside
        • Contact:
          • Philip Mitchell, Site 0105
          • Phone Number: 0294331546
    • Queensland
      • Brisbane, Queensland, Australia, 4005
        • Recruiting
        • Ramsay Clinic New Farm
        • Contact:
          • James Scott, Site 0087
          • Phone Number: 0408707842
  • Bulgaria
      • Burgas, Bulgaria, 8001
        • Recruiting
        • Center for Mental Health Prof. Dr. Ivan Temkov
        • Contact:
          • Veselin Palazov, Site 0082
          • Phone Number: 359888451225
      • Novi Iskar, Bulgaria, 1282
        • Recruiting
        • State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
        • Contact:
          • Tsveteslava Galabova, Site 0107
          • Phone Number: 359892444643
      • Pleven, Bulgaria, 5800
        • Recruiting
        • "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
        • Contact:
          • Maya Stoimenova - Popova, Site 0081
          • Phone Number: +359888227165
      • Sliven, Bulgaria, 8800
        • Recruiting
        • MHAT "Dr. Ival Seliminski"
        • Contact:
          • Rozalina Petrova, Site 0113
          • Phone Number: 00359887801545
      • Vratsa, Bulgaria, 3000
        • Recruiting
        • Mental Health Center - Vratsa
        • Contact:
          • Nadya Ivanova, Site 0114
          • Phone Number: +359887422440
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100088
        • Not yet recruiting
        • Local Institution - 0177
        • Contact:
          • Site 0177
      • Beijing, Beijing Municipality, China, 100096
        • Not yet recruiting
        • Local Institution - 0174
        • Contact:
          • Site 0174
    • Guangdong
      • Guangzhou, Guangdong, China, 510370
        • Not yet recruiting
        • Local Institution - 0175
        • Contact:
          • Site 0175
    • Hebei
      • Baoding, Hebei, China, 71000
        • Not yet recruiting
        • Local Institution - 0181
        • Contact:
          • Site 0181
      • Shijiazhuang, Hebei, China, 050031
        • Not yet recruiting
        • Local Institution - 0185
        • Contact:
          • Site 0185
    • Hunan
      • Changsha, Hunan, China, 410011
        • Not yet recruiting
        • Local Institution - 0184
        • Contact:
          • Site 0184
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Local Institution - 0180
        • Contact:
          • Site 0180
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • Local Institution - 0176
        • Contact:
          • Site 0176
    • Sichuan
      • Chengdu, Sichuan, China, 610036
        • Not yet recruiting
        • Local Institution - 0179
        • Contact:
          • Site 0179
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300022
        • Not yet recruiting
        • Local Institution - 0183
        • Contact:
          • Site 0183
    • Zhejiang
      • Ningbo, Zhejiang, China, 315201
        • Not yet recruiting
        • Local Institution - 0182
        • Contact:
          • Site 0182
  • Croatia
      • Zagreb, Croatia, 10090
        • Recruiting
        • Klinika za psihijatriju "Vrapče"
        • Contact:
          • Marko Curkovic, Site 0129
          • Phone Number: 385951648446
      • Zagreb, Croatia, 10090
        • Recruiting
        • Psihijatrijska bolnica "Sveti Ivan"
        • Contact:
          • Igor Filipcic, Site 0019
          • Phone Number: 38513430020
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10090
        • Withdrawn
        • Local Institution - 0018
  • Denmark
      • Glostrup Municipality, Denmark, 2600
        • Not yet recruiting
        • Local Institution - 0154
        • Contact:
          • Site 0154
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Not yet recruiting
        • Local Institution - 0153
        • Contact:
          • Site 0153
  • France
      • Clermont-Ferrand, France, 63000
        • Not yet recruiting
        • Local Institution - 0171
        • Contact:
          • Site 0171
      • Montpellier, France, 34295
        • Not yet recruiting
        • Local Institution - 0172
        • Contact:
          • Site 0172
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • Not yet recruiting
        • Local Institution - 0170
        • Contact:
          • Site 0170
  • Hungary
      • Budapest, Hungary, 1083
        • Recruiting
        • Semmelweis Egyetem
        • Contact:
          • János Réthelyi, Site 0108
          • Phone Number: +3612100336
      • Budapest, Hungary
        • Not yet recruiting
        • Local Institution - 0110
        • Contact:
          • Site 0110
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Recruiting
        • Petz Aladar Egyetemi Oktato Korhaz
        • Contact:
          • Gabor Feller, Site 0109
  • India
    • Gujarat
      • Vadodara, Gujarat, India, 390021
        • Not yet recruiting
        • Local Institution - 0111
        • Contact:
          • Site 0111
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Not yet recruiting
        • Local Institution - 0132
        • Contact:
          • Site 0132
      • Mangalore, Karnataka, India, 575003
        • Not yet recruiting
        • Local Institution - 0159
        • Contact:
          • Site 0159
      • Mangaluru, Karnataka, India, 574143
        • Not yet recruiting
        • Local Institution - 0190
        • Contact:
          • Site 0190
    • Kerala
      • Kozhikode, Kerala, India, 673009
        • Not yet recruiting
        • Local Institution - 0079
        • Contact:
          • Site 0079
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Not yet recruiting
        • Local Institution - 0077
        • Contact:
          • Site 0077
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Not yet recruiting
        • Local Institution - 0158
        • Contact:
          • Site 0158
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
      • Hyderabad, Telangana, India, 500082
        • Not yet recruiting
        • Local Institution - 0080
        • Contact:
          • Site 0080
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Not yet recruiting
        • Local Institution - 0076
        • Contact:
          • Site 0076
      • Kolkata, West Bengal, India, 700025
        • Not yet recruiting
        • Local Institution - 0160
        • Contact:
          • Site 0160
  • Israel
      • Ashkelon, Israel, 78306
        • Not yet recruiting
        • Local Institution - 0173
        • Contact:
          • Site 0173
      • Bnei Brak, Israel, 5154475
        • Not yet recruiting
        • Local Institution - 0187
        • Contact:
          • Site 0187
      • Jerusalem, Israel, 91120
        • Not yet recruiting
        • Local Institution - 0168
        • Contact:
          • Site 0168
      • Jerusalem, Israel, 9546105
        • Recruiting
        • Kfar Shaul Mental Health Center
        • Contact:
          • Alexander Teitelbaum, Site 0074
          • Phone Number: +972-506262005
    • Central District
      • Hod HaSharon, Central District, Israel, 4534708
        • Recruiting
        • Shalvata Mental Health Center
        • Contact:
          • Yuri Fonar, Site 0068
          • Phone Number: +972545838725
      • Ness Ziona, Central District, Israel, 7410001
        • Recruiting
        • Ness Ziona Mental Health Center
        • Contact:
          • Marina Kupchik, Site 0075
          • Phone Number: +972506261093
      • Petah Tikva, Central District, Israel, 4910002
        • Not yet recruiting
        • Local Institution - 0084
        • Contact:
          • Site 0084
      • Ramat Gan, Central District, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
        • Contact:
          • Linda Levi-Haramati, Site 0067
          • Phone Number: 0585950299
    • Southern District
      • Beersheba, Southern District, Israel, 8461144
        • Recruiting
        • Be'er Sheva Mental Health Center
        • Contact:
          • Yuly Bersudsky, Site 0106
          • Phone Number: 972-8-6401463
  • Italy
      • Ancona, Italy, 60126
        • Not yet recruiting
        • Local Institution - 0070
        • Contact:
          • Site 0070
      • Genova, Italy, 16132
        • Not yet recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Not yet recruiting
        • Local Institution - 0066
        • Contact:
          • Site 0066
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Not yet recruiting
        • Local Institution - 0083
        • Contact:
          • Site 0083
      • Siena, Tuscany, Italy, 53100
        • Not yet recruiting
        • Local Institution - 0065
        • Contact:
          • Site 0065
  • Japan
      • Fukuoka, Japan, 819-0037
        • Recruiting
        • Kuramitsu Hospital
        • Contact:
          • Noriko Tamaru, Site 0006
          • Phone Number: +81-92-811-1821
      • Kochi, Japan, 781-8555
        • Recruiting
        • Kochi Health Sciences Center
        • Contact:
          • Ken Sawada, Site 0161
          • Phone Number: +81-88-837-3000
      • Miyazaki, Japan, 880-8510
        • Recruiting
        • Miyazaki Prefectural Miyazaki Hospital
        • Contact:
          • Jiro Kawano, Site 0004
          • Phone Number: 81985244181
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital
        • Contact:
          • Yasuhiko Deguchi, Site 0010
          • Phone Number: +81-6-6645-3821
      • Tokyo, Japan, 157-8577
        • Recruiting
        • Showa Medical University Karasuyama Hospital
        • Contact:
          • Kenji Sanada, Site 0073
          • Phone Number: +81-3-3300-5231
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
          • Sohei Kimoto, Site 0002
          • Phone Number: 073-441-0659
      • Yamagata, Japan, 990-0045
        • Recruiting
        • Yamagata Sakuracho Hospital
        • Contact:
          • Nobuhiro Yokokawa, Site 0014
          • Phone Number: +81236312315
    • Aichi-ken
      • Kōnan, Aichi-ken, Japan, 4838248
        • Recruiting
        • Hotei Hospital
        • Contact:
          • Takakura Masashi, Site 0008
          • Phone Number: +81587557251
      • Toyoake, Aichi-ken, Japan, 470-1168
        • Recruiting
        • Okehazama Hospital
        • Contact:
          • kiyoshi Fujita, Site 0003
          • Phone Number: 0562971361
    • Chiba
      • Ichikawa, Chiba, Japan, 272-8516
        • Recruiting
        • National Kohnodai Medical Center.
        • Contact:
          • Toshihiko Ito, Site 0001
          • Phone Number: +81-47-372-3501
    • Fukuoka
      • Iizuka, Fukuoka, Japan, 820-8505
        • Withdrawn
        • Local Institution - 0166
      • Kitakyushu, Fukuoka, Japan, 803-0831
        • Withdrawn
        • Local Institution - 0063
    • Hokkaido
      • Obihiro, Hokkaido, Japan, 080-0024
        • Recruiting
        • Obihiro Kosei Hospital
        • Contact:
          • Kengo Furuse, Site 0015
          • Phone Number: 81155650102
      • Sapporo, Hokkaido, Japan, 002-8029
        • Recruiting
        • Goryokai Medical Corporation - Goryokai Hospital
        • Contact:
          • Kimihiro Nakajima, Site 0005
          • Phone Number: +81-11-771-5660
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 234-0051
        • Not yet recruiting
        • Local Institution - 0165
        • Contact:
          • Site 0165
    • Osaka
      • Moriguchi, Osaka, Japan, 570-8507
        • Recruiting
        • Kansai Medical University Medical Center
        • Contact:
          • Masaki Kato, Site 0013
          • Phone Number: +81-6-6992-1001
      • Sakai-shi, Osaka, Japan, 590-0018
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Saga-ken
      • Karatsu-shi, Saga-ken, Japan, 847-0031
        • Recruiting
        • Rainbow and Sea Hospital
        • Contact:
          • Taro Shindo, Site 0011
          • Phone Number: 0955770711
    • Saitama
      • Iruma, Saitama, Japan, 350-0495
        • Withdrawn
        • Local Institution - 0016
      • Kumagaya, Saitama, Japan, 360-0114
        • Recruiting
        • Saitama Konan Hospital
        • Contact:
          • Narifumi Yokoyama, Site 0012
          • Phone Number: 048-536-1366
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
          • Amane Tateno, Site 0164
          • Phone Number: +81-3-3822-2131
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Not yet recruiting
        • Local Institution - 0163
        • Contact:
          • Site 0163
      • Kodaira, Tokyo, Japan, 187-8551
        • Recruiting
        • National Center of Neurology and Psychiatry
        • Contact:
          • Takamasa Noda, Site 0072
          • Phone Number: +81-42-341-2711
      • tabashi City, Tokyo, Japan, 175-0091
        • Recruiting
        • Narimasu Kosei Hospital
        • Contact:
          • Yuya Tenjin, Site 0009
          • Phone Number: 0339391191
  • New Zealand
      • Auckland, New Zealand, 0622
        • Recruiting
        • North Shore Hospital
        • Contact:
          • Sylvester Miles, Site 0086
          • Phone Number: +6421963555
  • Poland
      • Tuszyn, Poland, 95-080
        • Recruiting
        • Clinica Inventiva
        • Contact:
          • Jaroslaw Strzelec, Site 0091
          • Phone Number: 602305132
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-485
        • Recruiting
        • Centrum Medyczne HCP
        • Contact:
          • Sylwia Szymkowiak, Site 0088
          • Phone Number: +48604116632
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-957
        • Recruiting
        • Instytut Psychiatrii i Neurologii
        • Contact:
          • Adam Wichniak, Site 0092
          • Phone Number: +48600-107-410
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-272
        • Recruiting
        • Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
        • Contact:
          • Napoleon Waszkiewicz, Site 0090
          • Phone Number: +48608888796
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Not yet recruiting
        • Local Institution - 0093
        • Contact:
          • Site 0093
    • Silesian Voivodeship
      • Rybnik, Silesian Voivodeship, Poland, 44-200
        • Recruiting
        • M2M Med
        • Contact:
          • Wojciech Eysymontt, Site 0089
          • Phone Number: +48609673001
  • Romania
      • Bucharest, Romania, 060222
        • Recruiting
        • Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
        • Contact:
          • Traian Barbu, Site 0104
          • Phone Number: +40723652564
      • Bucharest, Romania, 011241
        • Not yet recruiting
        • Local Institution - 0167
        • Contact:
          • Site 0167
      • Bucharest, Romania
        • Recruiting
        • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
        • Contact:
          • Octavian Vasiliu, Site 0094
          • Phone Number: 0040723725815
      • Iași, Romania, 700282
        • Not yet recruiting
        • Local Institution - 0097
        • Contact:
          • Site 0097
      • Sanpetru /Brasov, Romania, 507190
        • Recruiting
        • Spitalul de Psihiatrie și Neurologie Brașov
        • Contact:
          • Petru Ifteni, Site 0100
          • Phone Number: 0040724993329
    • Bucharest
      • Bucharest, Bucharest, Romania, 041914
        • Recruiting
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
        • Contact:
          • ADELA CIOBANU, Site 0096
          • Phone Number: 0040723671301
      • Bucharest, Bucharest, Romania, 041914
        • Not yet recruiting
        • Local Institution - 0095
        • Contact:
          • Site 0095
  • Slovakia
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 01
        • Not yet recruiting
        • Local Institution - 0118
        • Contact:
          • Site 0118
      • Košice, Košice Region, Slovakia, 040 01
        • Not yet recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
    • Presov
      • Vranov nad Topľou, Presov, Slovakia, 093 01
        • Not yet recruiting
        • Local Institution - 0117
        • Contact:
          • Site 0117
  • Spain
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Josep Antoni Ramos-Quiroga, Site 0115
          • Phone Number: +34934894295
    • Basque Country
      • Bilbao, Basque Country, Spain, 48013
        • Recruiting
        • Osi Bilbao-Basurto
        • Contact:
          • Ana Catalan, Site 0064
          • Phone Number: 669736802
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
          • Eduard Vieta, Site 0071
          • Phone Number: 932275400
  • Sweden
    • Stockholms Län [se-01]
      • Nacka, Stockholms Län [se-01], Sweden, 131 45
        • Recruiting
        • Nacka Local Hospital
        • Contact:
          • Andreas Carlborg, Site 0125
          • Phone Number: +46(0)8-12341043
    • Uppsala Län [se-03]
      • Uppsala, Uppsala Län [se-03], Sweden, 751 85
        • Withdrawn
        • Local Institution - 0112
    • Västra Götalands Län [se-14]
      • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
        • Withdrawn
        • Local Institution - 0116
  • Ukraine
      • Dnipro, Ukraine, 49115
        • Not yet recruiting
        • Local Institution - 0149
        • Contact:
          • Site 0149
      • Kropyvnytskyi, Ukraine, 25491
        • Not yet recruiting
        • Local Institution - 0151
        • Contact:
          • Site 0151
      • Kyiv, Ukraine, 04080
        • Not yet recruiting
        • Local Institution - 0150
        • Contact:
          • Site 0150
      • Poltava, Ukraine, 36013
        • Not yet recruiting
        • Local Institution - 0141
        • Contact:
          • Site 0141
    • Cherkasy Oblast
      • Smila, Cherkasy Oblast, Ukraine, 20708
        • Not yet recruiting
        • Local Institution - 0152
        • Contact:
          • Site 0152
    • Khmelnytskyi Oblast
      • Skarzhyntsi, Khmelnytskyi Oblast, Ukraine, 32120
        • Not yet recruiting
        • Local Institution - 0146
        • Contact:
          • Site 0146
    • Kyivska Oblast
      • Hlevakha, Kyivska Oblast, Ukraine, 08631
        • Not yet recruiting
        • Local Institution - 0143
        • Contact:
          • Site 0143
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79021
        • Not yet recruiting
        • Local Institution - 0147
        • Contact:
          • Site 0147
    • Odesa Oblast
      • Oleksandrivka, Odesa Oblast, Ukraine, 67513
        • Not yet recruiting
        • Local Institution - 0145
        • Contact:
          • Site 0145
    • Ternopil Oblast
      • Ternopil, Ternopil Oblast, Ukraine, 460027
        • Not yet recruiting
        • Local Institution - 0189
        • Contact:
          • Site 0189
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
        • Not yet recruiting
        • Local Institution - 0148
        • Contact:
          • Site 0148
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Not yet recruiting
        • Local Institution - 0120
        • Contact:
          • Site 0120
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Recruiting
        • Pillar Clinical Research - Richardson
        • Contact:
          • Fayz Hudefi, Site 0022
          • Phone Number: 479-367-2688
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Woodland International Research Group
        • Contact:
          • George Konis, Site 0038
          • Phone Number: 501-221-8681
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Pillar Clinical Research- Little Rock
        • Contact:
          • Leslie Smith, Site 0021
          • Phone Number: 501-350-3285
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Woodland Research Northwest
        • Contact:
          • Robert Billingsley, Site 0057
          • Phone Number: 479-927-3000
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center Inc.
        • Contact:
          • Steven Macina, Site 0027
          • Phone Number: 714-999-6688
      • Bellflower, California, United States, 90706
        • Recruiting
        • Clinical Innovations, Inc. dba CITrials
        • Contact:
          • Robert Bota, Site 0050
          • Phone Number: 229-815-0219
      • Cerritos, California, United States, 90703
        • Not yet recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
      • Chino, California, United States, 91710
        • Recruiting
        • Inland Psychiatric Medical Group - Chino
        • Contact:
          • Nandita Puchakayala, Site 0135
          • Phone Number: 909-488-9116
      • Culver City, California, United States, 90230
        • Recruiting
        • Proscience Research Group
        • Contact:
          • Marina Bussel, Site 0037
          • Phone Number: 424-227-8127
      • Garden Grove, California, United States, 92845-2506
        • Recruiting
        • Collaborative Neuroscience Research, LLC
        • Contact:
          • David Walling, Site 0085
          • Phone Number: 714-799-7799
      • La Habra, California, United States, 90631
        • Recruiting
        • Omega Clinical Trials - La Habra
        • Contact:
          • Wakelin McNeel, Site 0137
          • Phone Number: 562-690-2200
      • Montclair, California, United States, 91763
        • Recruiting
        • Catalina Research Institute, LLC
        • Contact:
          • Stephen Volk, Site 0056
          • Phone Number: 909-590-8409
      • Orange, California, United States, 92868
        • Recruiting
        • NRC Research Institute
        • Contact:
          • Tony Ortiz, Site 0039
          • Phone Number: 714-289-1100
      • Riverside, California, United States, 92506
        • Recruiting
        • Clinical Innovations, Inc. dba CITrials
        • Contact:
          • Evagelos Coskinas, Site 0043
          • Phone Number: 951300492
      • Santa Ana, California, United States, 92705
        • Not yet recruiting
        • Local Institution - 0136
        • Contact:
          • Site 0136
      • Torrance, California, United States, 90504
        • Recruiting
        • Collaborative Neuroscience Research, LLC
        • Contact:
          • Lara Shirikjian, Site 0123
          • Phone Number: 310-523-4200
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital-Smilow Cancer Center
        • Contact:
          • Deepak D'Souza, Site 0131
          • Phone Number: 20393257112594
    • Florida
      • Hallandale, Florida, United States, 33009
        • Recruiting
        • Velocity Clinical Research, Hallandale Beach
        • Contact:
          • Beth Safirstein, Site 0133
      • Hialeah Gardens, Florida, United States, 33016
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Research Centers of America ( Hollywood )
        • Contact:
          • Edwin Gomez, Site 0053
          • Phone Number: 954-604-3900
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Behavioral Clinical Research
        • Contact:
          • Olga Lapeyra, Site 0059
          • Phone Number: 954-375-7794
      • Miami, Florida, United States, 33135
        • Recruiting
        • Advanced Research Institute of Miami
        • Contact:
          • Moraima Trujillo, Site 0028
          • Phone Number: 305-246-0001
      • Miami, Florida, United States, 33126
        • Recruiting
        • LCC Medical Research Institute
        • Contact:
          • Yesenia Kuan, Site 0030
          • Phone Number: 305-400-0814
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Innovative Clinical Research, Inc.
        • Contact:
          • Rishi Kakar, Site 0047
          • Phone Number: 786-512-4106
      • Miami Springs, Florida, United States, 33166
        • Recruiting
        • South Florida Research Phase I-IV
        • Contact:
          • Silvia Silva Duluc, Site 0025
          • Phone Number: 305-669-6166
      • St. Petersburg, Florida, United States, 33713
        • Not yet recruiting
        • Local Institution - 0045
        • Contact:
          • Site 0045
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Health Synergy Clinical Research
        • Contact:
          • Mohammad Nisar, Site 0032
          • Phone Number: 786-831-7303
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Synexus Clinical Research US, Inc.
        • Contact:
          • Bethany Davis, Site 0052
          • Phone Number: 404-255-6005
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
        • Contact:
          • Elyssa Barron, Site 0054
          • Phone Number: 404-881-5800
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Kimball Johnson, Site 0023
          • Phone Number: 404-537-1281
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Michael Mobley, Site 0024
          • Phone Number: 912-744-0800
    • Illinois
      • Chicago, Illinois, United States, 60641
        • Recruiting
        • Pillar Clinical Research -Chicago
        • Contact:
          • Roueen Rafeyan, Site 0020
          • Phone Number: 312-865-6336
      • Chicago, Illinois, United States, 60640
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Recruiting
        • CBH Health
        • Contact:
          • Elia Acevedo Diaz, Site 0049
          • Phone Number: 301-251-4702
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Precise Research Centers
        • Contact:
          • Joseph Kwentus, Site 0029
          • Phone Number: 601-420-5810
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Arch Clinical Trials
        • Contact:
          • Junaid Syed, Site 0042
          • Phone Number: 314-771-6387
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Not yet recruiting
        • Local Institution - 0121
        • Contact:
          • Site 0121
      • North Las Vegas, Nevada, United States, 89030
        • Withdrawn
        • Local Institution - 0122
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Hassman Research Institute Marlton Site
        • Contact:
          • Elan Cohen, Site 0130
          • Phone Number: 267-981-8911
      • Marlton, New Jersey, United States, 08053
        • Withdrawn
        • Local Institution - 0058
    • New York
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Richmond Behavioral Associates
        • Contact:
          • Peter Weiden, Site 0033
          • Phone Number: 917-701-7484
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Withdrawn
        • Local Institution - 0124
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Caleb Adler, Site 0055
          • Phone Number: 513-404-0279
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro-Behavioral Clinical Research
        • Contact:
          • Shishuka Malhotra, Site 0040
          • Phone Number: 330-493-1118
    • Texas
      • Austin, Texas, United States, 78754
        • Recruiting
        • Community Clinical Research
        • Contact:
          • David Brown, Site 0134
          • Phone Number: 512-323-2622
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • InSite Clinical Research
        • Contact:
          • Rajinder Shiwach, Site 0048
          • Phone Number: 972-283-6286
      • Houston, Texas, United States, 77021
        • Withdrawn
        • Local Institution - 0046
      • Houston, Texas, United States, 77058
        • Recruiting
        • Elevate Clinical Research-Houston
        • Contact:
          • Matthews Brams, Site 0138
          • Phone Number: 409-331-6040
      • Irving, Texas, United States, 75062
        • Withdrawn
        • Local Institution - 0036
      • Mansfield, Texas, United States, 76063
        • Recruiting
        • Prime Clinical Research - Mansfield
        • Contact:
          • Jamie Alexander, Site 0139
          • Phone Number: 817-907-7330
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Pillar Clinical Research - Richardson
        • Contact:
          • Scott Bartley, Site 0034
          • Phone Number: 214-396-4844

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 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:

  • 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:

    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.
    2. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
    3. 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.
    4. 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.
    5. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
    6. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
    7. 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KarXT or Adjuvant KarXT
Drug: KarXT
Specified dose on specified days
Other Names:
  • BMS-986510
  • Xanomeline and trospium chloride
Drug: Lithium
Therapeutic dose
Drug: Valproate
Therapeutic dose
Drug: Lamotrigine
Therapeutic dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment emergent adverse events (TEAEs)
Time Frame: Up to week 54
Up to week 54

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with AEs of special interest (AESIs)
Time Frame: Up to week 54
Up to week 54
Number of participants with serious AEs (SAEs)
Time Frame: Up to week 54
Up to week 54
Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to week 54
Up to week 54
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
Time Frame: Up to week 54
Up to week 54
Change from baseline in Simpson Angus Scale (SAS) score
Time Frame: Up to week 54
Up to week 54
Change from baseline in International Prostate Symptom Score (IPSS)
Time Frame: Up to week 54
Only for males ≥ 45 years of age
Up to week 54
Number of participants with TEAEs leading to treatment discontinuation
Time Frame: Up to week 52
Up to week 52
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score
Time Frame: Up to week 54
Up to week 54

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)

July 18, 2025

Primary Completion (Estimated)

June 13, 2028

Study Completion (Estimated)

June 13, 2028

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0038
  • U1111-1316-9287 (Other Identifier: WHO)
  • 2024-520259-26 (Other Identifier: EU CTR)

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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