A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
NCT ID: NCT06929273
Last Updated: 2025-11-12
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
450 participants
INTERVENTIONAL
2025-07-18
2028-06-13
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KarXT or Adjuvant KarXT
KarXT
Specified dose on specified days
Lithium
Therapeutic dose
Valproate
Therapeutic dose
Lamotrigine
Therapeutic dose
Interventions
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KarXT
Specified dose on specified days
Lithium
Therapeutic dose
Valproate
Therapeutic dose
Lamotrigine
Therapeutic dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
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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Local Institution - 0120
Glendale, Arizona, United States
Pillar Clinical Research - Richardson
Bentonville, Arkansas, United States
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Local Institution - 0057
Rogers, Arkansas, United States
Advanced Research Center Inc.
Anaheim, California, United States
Clinical Innovations, Inc. dba CITrials
Bellflower, California, United States
Local Institution - 0044
Cerritos, California, United States
Local Institution - 0135
Chino, California, United States
Proscience Research Group
Culver City, California, United States
Local Institution - 0085
Garden Grove, California, United States
Local Institution - 0056
Montclair, California, United States
NRC Research Institute
Orange, California, United States
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States
Local Institution - 0123
Torrance, California, United States
Local Institution - 0131
New Haven, Connecticut, United States
Local Institution - 0133
Hallandale, Florida, United States
Local Institution - 0026
Hialeah Gardens, Florida, United States
Behavioral Clinical Research
Hollywood, Florida, United States
Local Institution - 0053
Hollywood, Florida, United States
Local Institution - 0030
Miami, Florida, United States
Advanced Research Institute of Miami
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 - 0045
St. Petersburg, Florida, United States
Health Synergy Clinical Research
Stuart, Florida, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Local Institution - 0024
Savannah, Georgia, United States
Local Institution - 0031
Chicago, Illinois, United States
Pillar Clinical Research -Chicago
Chicago, Illinois, United States
Local Institution - 0049
Gaithersburg, Maryland, United States
Local Institution - 0029
Flowood, Mississippi, United States
Arch Clinical Trials
St Louis, Missouri, United States
Local Institution - 0121
North Las Vegas, Nevada, United States
Local Institution - 0122
North Las Vegas, Nevada, United States
Local Institution - 0058
Marlton, New Jersey, United States
Local Institution - 0130
Marlton, New Jersey, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Local Institution - 0124
Charlotte, North Carolina, United States
Local Institution - 0055
Cincinnati, Ohio, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States
Local Institution - 0134
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Local Institution - 0046
Houston, Texas, United States
Local Institution - 0036
Irving, Texas, United States
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Local Institution - 0128
ABB, Buenos Aires F.D., Argentina
Local Institution - 0127
Córdoba, , Argentina
Local Institution - 0126
Mendoza, , Argentina
Ramsay Clinic Northside
St Leonards, New South Wales, Australia
Ramsay Clinic New Farm
Brisbane, Queensland, Australia
Center for Mental Health Prof. Dr. Ivan Temkov
Burgas, , Bulgaria
Local Institution - 0107
Novi Iskar, , Bulgaria
Local Institution - 0081
Pleven, , Bulgaria
Local Institution - 0113
Sliven, , Bulgaria
Local Institution - 0114
Vratsa, , Bulgaria
Local Institution - 0018
Zagreb, City of Zagreb, Croatia
Local Institution - 0017
Zagreb, , Croatia
Local Institution - 0019
Zagreb, , Croatia
Local Institution - 0103
Zagreb, , Croatia
Local Institution - 0129
Zagreb, , Croatia
Local Institution - 0154
Glostrup Municipality, Capital Region, Denmark
Local Institution - 0153
Aalborg, North Denmark, Denmark
Local Institution - 0109
Győr, Győr-Moson-Sopron, Hungary
Local Institution - 0110
Budapest, , Hungary
Local Institution - 0108
Budapest, , Hungary
Local Institution - 0111
Vadodara, Gujarat, India
Local Institution - 0132
Belagavi, Karnataka, India
Local Institution - 0159
Mangalore, Karnataka, India
Local Institution - 0079
Kozhikode, Kerala, India
Local Institution - 0077
Ludhiana, Punjab, India
Local Institution - 0158
Madurai, Tamil Nadu, India
Local Institution - 0078
Hyderabad, Telangana, India
Local Institution - 0080
Hyderabad, Telangana, India
Local Institution - 0076
Kolkata, West Bengal, India
Local Institution - 0160
Kolkata, West Bengal, India
Local Institution - 0068
Hod HaSharon, Central District, Israel
Local Institution - 0075
Ness Ziona, Central District, Israel
Local Institution - 0084
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Be'er Sheva Mental Health Center
Beersheba, Southern District, Israel
Local Institution - 0074
Jerusalem, , Israel
Local Institution - 0066
Milan, Lombardy, Italy
Local Institution - 0083
Pisa, Tuscany, Italy
Local Institution - 0065
Siena, Tuscany, Italy
Local Institution - 0070
Ancona, , Italy
Local Institution - 0069
Genova, , Italy
Local Institution - 0008
Kōnan, Aichi-ken, Japan
Okehazama Hospital
Toyoake, Aichi-ken, Japan
National Kohnodai Medical Center.
Ichikawa, Chiba, Japan
Local Institution - 0166
Iizuka, Fukuoka, Japan
Local Institution - 0063
Kitakyushu, Fukuoka, Japan
Obihiro Kosei Hospital
Obihiro, Hokkaido, Japan
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan
Local Institution - 0165
Yokohama, Kanagawa, Japan
Local Institution - 0007
Sakai-shi, Osaka, Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan
Local Institution - 0016
Iruma, Saitama, Japan
Saitama Konan Hospital
Kumagaya, Saitama, Japan
Local Institution - 0164
Bunkyo-ku, Tokyo, Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan
Narimasu Kosei Hospital
tabashi City, Tokyo, Japan
Kuramitsu Hospital
Fukuoka, , Japan
Local Institution - 0161
Kochi, , Japan
Local Institution - 0004
Miyazaki, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Local Institution - 0013
Osaka, , Japan
Local Institution - 0163
Tokyo, , Japan
Showa Medical University Karasuyama Hospital
Tokyo, , Japan
Local Institution - 0002
Wakayama, , Japan
Local Institution - 0014
Yamagata, , Japan
Local Institution - 0086
Auckland, , New Zealand
Local Institution - 0088
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0092
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0090
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0093
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0089
Rybnik, Silesian Voivodeship, Poland
Local Institution - 0091
Tuszyn, Łódź Voivodeship, Poland
Local Institution - 0095
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
Local Institution - 0167
Bucharest, , Romania
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Bucharest, , Romania
Local Institution - 0094
Bucharest, , Romania
Local Institution - 0097
Iași, , Romania
Local Institution - 0100
Sanpetru /Brasov, , Romania
Local Institution - 0118
Košice, Košice Region, Slovakia
Local Institution - 0119
Košice, Košice Region, Slovakia
Local Institution - 0117
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 - 0112
Uppsala, Uppsala Län [se-03], Sweden
Local Institution - 0116
Gothenburg, Västra Götalands Län [se-14], Sweden
Local Institution - 0152
Smila, Cherkasy Oblast, Ukraine
Local Institution - 0149
Dnipro, Dnipropetrovsk Oblast, Ukraine
Local Institution - 0142
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Local Institution - 0146
Skarzhyntsi, Khmelnytskyi Oblast, Ukraine
Local Institution - 0143
Hlevakha, Kyiv Oblast, Ukraine
Local Institution - 0150
Kyiv, Kyivska Oblast, Ukraine
Local Institution - 0147
Lviv, Lviv Oblast, Ukraine
Local Institution - 0145
Oleksandrivka, Odesa Oblast, Ukraine
Local Institution - 0141
Poltava, Poltava Oblast, Ukraine
Local Institution - 0148
Vinnytsia, Vinnytsia Oblast, Ukraine
Local Institution - 0151
Kropyvnytskyi, , Ukraine
Local Institution - 0144
Odesa, , Ukraine
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 08559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Site 0120
Role: primary
Fayz Hudefi, Site 0022
Role: primary
Leslie Smith, Site 0021
Role: primary
George Konis, Site 0038
Role: primary
Site 0057
Role: primary
Steven Macina, Site 0027
Role: primary
Robert Bota, Site 0050
Role: primary
Site 0044
Role: primary
Site 0135
Role: primary
Marina Bussel, Site 0037
Role: primary
Site 0085
Role: primary
Site 0056
Role: primary
Tony Ortiz, Site 0039
Role: primary
Evagelos Coskinas, Site 0043
Role: primary
Site 0123
Role: primary
Site 0131
Role: primary
Site 0133
Role: primary
Site 0026
Role: primary
Olga Lapeyra, Site 0059
Role: primary
Site 0053
Role: primary
Site 0030
Role: primary
Moraima Trujillo, Site 0028
Role: primary
Rishi Kakar, Site 0047
Role: primary
Silvia Silva-Duluc, Site 0025
Role: primary
Site 0045
Role: primary
Mohammad Nisar, Site 0032
Role: primary
Bethany Davis, Site 0052
Role: primary
Elyssa Barron, Site 0054
Role: primary
Kimball Johnson, Site 0023
Role: primary
Site 0024
Role: primary
Site 0031
Role: primary
Roueen Rafeyan, Site 0020
Role: primary
Site 0049
Role: primary
Site 0029
Role: primary
Junaid Syed, Site 0042
Role: primary
Site 0121
Role: primary
Site 0130
Role: primary
Peter Weiden, Site 0033
Role: primary
Site 0124
Role: primary
Site 0055
Role: primary
Shishuka Malhotra, Site 0040
Role: primary
Site 0134
Role: primary
SURESH SUREDDI, Site 0048
Role: primary
Site 0046
Role: primary
Scott Bartley, Site 0034
Role: primary
Site 0128
Role: primary
Site 0127
Role: primary
Site 0126
Role: primary
Philip Mitchell, Site 0105
Role: primary
James Scott, Site 0087
Role: primary
Veselin Palazov, Site 0082
Role: primary
Site 0107
Role: primary
Site 0081
Role: primary
Site 0113
Role: primary
Site 0114
Role: primary
Site 0017
Role: primary
Site 0019
Role: primary
Site 0103
Role: primary
Site 0129
Role: primary
Site 0154
Role: primary
Site 0153
Role: primary
Site 0109
Role: primary
Site 0110
Role: primary
Site 0108
Role: primary
Site 0111
Role: primary
Site 0132
Role: primary
Site 0159
Role: primary
Site 0079
Role: primary
Site 0077
Role: primary
Site 0158
Role: primary
Site 0078
Role: primary
Site 0080
Role: primary
Site 0076
Role: primary
Site 0160
Role: primary
Site 0068
Role: primary
Site 0075
Role: primary
Site 0084
Role: primary
Mark Weiser, Site 0067
Role: primary
Yuly Bersudsky, Site 0106
Role: primary
Site 0074
Role: primary
Site 0066
Role: primary
Site 0083
Role: primary
Site 0065
Role: primary
Site 0070
Role: primary
Site 0069
Role: primary
Site 0008
Role: primary
kiyoshi Fujita, Site 0003
Role: primary
Toshihiko Ito, Site 0001
Role: primary
Site 0166
Role: primary
Kengo Furuse, Site 0015
Role: primary
Kimihiro Nakajima, Site 0005
Role: primary
Site 0165
Role: primary
Site 0007
Role: primary
Taro Shindo, Site 0011
Role: primary
Narifumi Yokoyama, Site 0012
Role: primary
Site 0164
Role: primary
Takamasa Noda, Site 0072
Role: primary
Yuya Tenjin, Site 0009
Role: primary
Noriko Tamaru, Site 0006
Role: primary
Site 0161
Role: primary
Site 0004
Role: primary
Yasuhiko Deguchi, Site 0010
Role: primary
Site 0013
Role: primary
Site 0163
Role: primary
Kenji Sanada, Site 0073
Role: primary
Site 0002
Role: primary
Site 0014
Role: primary
Site 0086
Role: primary
Site 0088
Role: primary
Site 0092
Role: primary
Site 0090
Role: primary
Site 0093
Role: primary
Site 0089
Role: primary
Site 0091
Role: primary
Site 0095
Role: primary
Valentin Matei, Site 0101
Role: primary
Mihnea Manea, Site 0102
Role: primary
SIMONA TRIFU, Site 0099
Role: primary
Corina Nicolae, Site 0098
Role: primary
ADELA CIOBANU, Site 0096
Role: primary
Site 0167
Role: primary
Traian Barbu, Site 0104
Role: primary
Site 0094
Role: primary
Site 0097
Role: primary
Site 0100
Role: primary
Site 0118
Role: primary
Site 0119
Role: primary
Site 0117
Role: primary
Josep Antoni Ramos-Quiroga, Site 0115
Role: primary
Ana Catalan, Site 0064
Role: primary
Eduard Vieta, Site 0071
Role: primary
Andreas Carlborg, Site 0125
Role: primary
Site 0152
Role: primary
Site 0149
Role: primary
Site 0142
Role: primary
Site 0146
Role: primary
Site 0143
Role: primary
Site 0150
Role: primary
Site 0147
Role: primary
Site 0145
Role: primary
Site 0141
Role: primary
Site 0148
Role: primary
Site 0151
Role: primary
Site 0144
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1316-9287
Identifier Type: OTHER
Identifier Source: secondary_id
2024-520259-26
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0038
Identifier Type: -
Identifier Source: org_study_id