RecruitingNCT06929273

A Study to Assess the Long-term Safety of KarXT for the Treatment of manic episodes in Bipolarity type I (BALSAM-3)

This study is recruiting. It focuses on bipolarity and currently lists participation information in the United States, Argentina, Australia, Bulgaria, China, Croatia, Denmark, France, Hungary, India, Israel, Italy, Japan, New Zealand, Poland, Romania, Slovakia, Spain, Sweden, and Ukraine.

BipolarityDrugFrom 18 Years to 65 Years

In plain English

Key information made simple

This study is looking at care and outcomes for people with bipolarity Type I With Mania. Taking part may give some people access to KarXT, but direct benefit is not guaranteed.

What to expect

Your next step

The official record suggests in-person participation through a hospital, with sites including Local Institution - 0120 in Glendale, Pillar Clinical Research - Richardson in Bentonville, and Pillar Clinical Research- Little Rock. Participation appears to involve a study treatment together with follow-up visits and routine safety or progress checks. The main fit is usually matching the main diagnosis and meeting the main study requirements, while common reasons not to take part include safety concerns that need urgent care first and active substance or alcohol problems that could affect the results. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.

Public study data

Key study information

Official title: 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)
Condition: Bipolar Disorder Type I With Mania
Study status: Recruiting
Phase: Phase 3
Sponsor / lead affiliation: Bristol-Myers Squibb
Intervention: KarXT, Lithium, Valproate, Lamotrigine
Location / country: United States, Argentina, Australia, Bulgaria, China, Croatia, Denmark, France, Hungary, India, Israel, Italy, Japan, New Zealand, Poland, Romania, Slovakia, Spain, Sweden, Ukraine
Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, First line of the email MUST contain NCT # and Site #., Site 0120, Fayz Hudefi, Site 0022, Leslie Smith, Site 0021, George Konis, Site 0038, Robert Billingsley, Site 0057, Steven Macina, Site 0027, Robert Bota, Site 0050, Site 0044, Nandita Puchakayala, Site 0135, Marina Bussel, Site 0037, David Walling, Site 0085, Wakelin McNeel, Site 0137, Stephen Volk, Site 0056, Tony Ortiz, Site 0039, Evagelos Coskinas, Site 0043, Lara Shirikjian, Site 0123, Site 0131, Beth Safirstein, Site 0133, Site 0026, Olga Lapeyra, Site 0059, Edwin Gomez, Site 0053, Yesenia Kuan, Site 0030, Moraima Trujillo, Site 0028, Rishi Kakar, Site 0047, Silvia Silva Duluc, Site 0025, Site 0045, Mohammad Nisar, Site 0032, Bethany Davis, Site 0052, Elyssa Barron, Site 0054, Kimball Johnson, Site 0023, Michael Mobley, Site 0024, Site 0031, Roueen Rafeyan, Site 0020, Elia Acevedo Diaz, Site 0049, Joseph Kwentus, Site 0029, Junaid Syed, Site 0042, Site 0121, Elan Cohen, Site 0130, Peter Weiden, Site 0033, Caleb Adler, Site 0055, Shishuka Malhotra, Site 0040, David Brown, Site 0134, Rajinder Shiwach, Site 0048, Site 0138, Jamie Alexander, Site 0139, Scott Bartley, Site 0034, Site 0128, Site 0127, Site 0126, Philip Mitchell, Site 0105, James Scott, Site 0087, Veselin Palazov, Site 0082, Tsveteslava Galabova, Site 0107, Maya Stoimenova - Popova, Site 0081, Rozalina Petrova, Site 0113, Nadya Ivanova, Site 0114, Site 0177, Site 0174, Site 0175, Site 0181, Site 0185, Site 0184, Site 0180, Site 0176, Site 0179, Site 0183, Site 0182, Miroslav Herceg, Site 0017, Ninoslav Mimica, Site 0103, Site 0129, Igor Filipcic, Site 0019, Site 0154, Site 0153, Site 0170, Site 0171, Site 0172, Gabor Feller, Site 0109, Site 0110, János Réthelyi, Site 0108, Site 0111, Site 0132, Site 0159, Site 0079, Site 0077, Site 0158, Site 0078, Site 0080, Site 0076, Site 0160, Yuri Fonar, Site 0068, Marina Kupchik, Site 0075, Site 0084, Linda Levi-Haramati, Site 0067, Yuly Bersudsky, Site 0106, Site 0173, Site 0187, Site 0168, Alexander Teitelbaum, Site 0074, Site 0066, Site 0083, Site 0065, Site 0070, Site 0069, Takakura Masashi, Site 0008, kiyoshi Fujita, Site 0003, Toshihiko Ito, Site 0001, Kengo Furuse, Site 0015, Kimihiro Nakajima, Site 0005, Site 0165, Masaki Kato, Site 0013, Site 0007, Taro Shindo, Site 0011, Narifumi Yokoyama, Site 0012, Site 0163, Site 0164, Takamasa Noda, Site 0072, Yuya Tenjin, Site 0009, Noriko Tamaru, Site 0006, Site 0161, Jiro Kawano, Site 0004, Yasuhiko Deguchi, Site 0010, Kenji Sanada, Site 0073, Sohei Kimoto, Site 0002, Nobuhiro Yokokawa, Site 0014, Sylvester Miles, Site 0086, Sylwia Szymkowiak, Site 0088, Adam Wichniak, Site 0092, Napoleon Waszkiewicz, Site 0090, Site 0093, Wojciech Eysymontt, Site 0089, Jaroslaw Strzelec, Site 0091, Site 0095, Valentin Matei, Site 0101, Mihnea Manea, Site 0102, SIMONA TRIFU, Site 0099, Corina Nicolae, Site 0098, ADELA CIOBANU, Site 0096, Site 0167, Traian Barbu, Site 0104, Octavian Vasiliu, Site 0094, Site 0097, Petru Ifteni, Site 0100, Site 0118, Site 0119, Site 0117, Josep Antoni Ramos-Quiroga, Site 0115, Ana Catalan, Site 0064, Eduard Vieta, Site 0071, Andreas Carlborg, Site 0125, Site 0152, Site 0149, Site 0143, Site 0147, Site 0145, Site 0148, Site 0151, Site 0150, Site 0141, Site 0146
Email: Clinical.Trials@bms.com
Phone: 855-907-3286, 479-367-2688, 501-350-3285, 501-221-8681, 479-927-3000, 714-999-6688, 229-815-0219, 909-488-9116, 424-227-8127, 714-799-7799, 562-690-2200, 909-590-8409, 714-289-1100, 951300492, 310-523-4200, 954-375-7794, 954-604-3900, 305-400-0814, 305-246-0001, 786-512-4106, 305-669-6166, 786-831-7303, 404-255-6005, 404-881-5800, 404-537-1281, 912-744-0800, 312-865-6336, 301-251-4702, 601-420-5810, 314-771-6387, 267-981-8911, 917-701-7484, 513-404-0279, 330-493-1118, 512-323-2622, 972-283-6286, 817-907-7330, 214-396-4844, 0294331546, 0408707842, 359888451225, 359892444643, +359888227165, 00359887801545, +359887422440, 3853780732, +38513780678, 38513430020, +3612100336, +972545838725, +972506261093, 0585950299, 972-8-6401463, +972-506262005, +81587557251, 0562971361, +81-47-372-3501, 81155650102, +81-11-771-5660, +81-6-6992-1001, 0955770711, 048-536-1366, +81-42-341-2711, 0339391191, +81-92-811-1821, 81985244181, +81-6-6645-3821, +81-3-3300-5231, 073-441-0659, +81236312315, +6421963555, +48604116632, +48600-107-410, +48608888796, +48609673001, 602305132, +40721243869, 0040745974029, 0040731581100, +40727818190, 0040723671301, +40723652564, 0040723725815, 0040724993329, +34934894295, 669736802, 932275400, +46(0)8-12341043
Registry: ClinicalTrials.gov

Why this study may matter

This study may matter because it is evaluating KarXT, Lithium, Valproate, Lamotrigine in a structured research setting. For people exploring bipolarity research, clear information about the goal, status, contacts, and official source can support better questions before any decision.

Before joining

Questions to ask before joining

What are the exact eligibility criteria, and what could exclude someone?
How many visits, assessments, or follow-ups are expected, and over what period?
What risks, side effects, practical burdens, or alternatives should be understood first?
Who should be contacted to confirm locations, timing, compensation, and next steps?

Official source

Registry reference

This page links back to the public source record so people can verify details directly with the registry and research team.

If you want the full study description, eligibility criteria, locations, and sponsor information in the original format, this is the place to check before taking the next step.

Open source record

Need help deciding?

Ask HopeStage to review this study with me

This form records your interest so HopeStage can follow up with practical guidance. It is not a medical eligibility decision and it does not guarantee a study spot.

Study reference: NCT06929273. We only ask for your email here. HopeStage can help you review the study, but this is not a medical eligibility decision.

In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular visits and structured follow-up.

Requires travel, with in-person participation in United States.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

Study clarity

Things to check before joining

Sponsor: Bristol-Myers Squibb
Sponsor type: Pharmaceutical company
Main activity: medication or study treatment
Intervention: KarXT, Lithium, Valproate, Lamotrigine
Time commitment: long follow-up or multiple visits
Study phase: Phase 3
Enrollment: Not available
Recruitment status: Recruiting
Source: Official registry link

FAQ

Questions about this study

What is A Study to Assess the Long-term Safety of KarXT for the Treatment of manic episodes in Bipolarity type I (BALSAM-3)?

This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed.

Who is behind this study, and what type of sponsor is it?

This study is sponsored by Bristol-Myers Squibb, a pharmaceutical company. The company develops medicines across several therapeutic areas, including oncology, hematology, immunology, cardiovascular disease, and neuroscience. The sponsor is based in the United States. Sponsor website: https://www.bms.com. You can verify the sponsor and study responsibility in the official registry record.

What does participation involve, what phase is it, and what should I ask about safety?

This study may involve medication or study treatment, study visits, and assessments. The time commitment is long follow-up or multiple visits. The study phase is Phase 3. Earlier-phase studies are often more focused on safety, dose, or feasibility, while later-phase studies usually involve more participants and more information about the intervention. The official source record gives the most accurate details. Enrollment is not available in HopeStage data. HopeStage cannot say whether a study is safe or right for you. Before joining, ask the research team about possible risks, time commitment, visits, side effects, compensation, safety monitoring, and whether participation may affect your current care.

Where can I verify the study details?

Use the official source record linked on this page to check the full study description, recruitment status, eligibility criteria, locations, sponsor information, phase, enrollment, contact details, and any listed risks or requirements.