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RecruitingNCT06951711

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of manic episodes in Bipolarity type I (BALSAM-2)

This study is recruiting. It focuses on bipolarity and currently lists participation information in the United States, Croatia, India, Israel, Italy, Romania, Slovakia, Spain, Sweden, and Ukraine.

BipolarityDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

This observational study is following people with bipolarity Type I With Mania or mania with mixed features to understand outcomes over time. Participants are followed over time so researchers can learn from clinical and follow-up information. This study may not offer a new treatment, and its main value is helping researchers learn from follow-up information that may improve future care.

What to expect

Your next step

The official record suggests in-person participation through a hospital, with sites including Pillar Clinical Research- Little Rock, Woodland Research Northwest in Rogers, and Proscience Research Group in Culver City. 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 active substance or alcohol problems that could affect the results and safety concerns that need urgent care first. 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, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Condition
Bipolar Disorder Type I With Mania or Mania With Mixed Features
Study status
Recruiting
Phase
Phase 3
Sponsor / lead affiliation
Bristol-Myers Squibb
Intervention
KarXT, Placebo
Location / country
United States, Croatia, India, Israel, Italy, Romania, Slovakia, Spain, Sweden, Ukraine
Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, First line of the email MUST contain NCT # and Site #., Leslie Smith, Site 0014, Robert Billingsley, Site 0025, Marina Bussel, Site 0021, Evagelos Coskinas, Site 0018, Lara Shirikjian, Site 0074, Olga Lapeyra, Site 0032, Yesenia Kuan, Site 0026, Rishi Kakar, Site 0081, Silvia Silva Duluc, Site 0015, Mohammad Nisar, Site 0083, Elyssa Barron, Site 0022, Kimball Johnson, Site 0016, Site 0020, Elia Acevedo Diaz, Site 0024, Joseph Kwentus, Site 0017, Junaid Syed, Site 0023, Elan Cohen, Site 0080, Caleb Adler, Site 0029, Shishuka Malhotra, Site 0038, Rajinder Shiwach, Site 0012, Scott Bartley, Site 0037, Miroslav Herceg, Site 0008, Ninoslav Mimica, Site 0063, Site 0078, Igor Filipcic, Site 0010, Site 0065, Site 0082, Site 0053, Site 0051, Site 0052, Site 0055, Site 0054, Yuri Fonar, Site 0042, Marina Kupchik, Site 0046, Site 0058, Linda Levi-Haramati, Site 0011, Yuly Bersudsky, Site 0066, Alexander Teitelbaum, Site 0045, Valentin Matei, Site 0048, Corina Nicolae, Site 0059, SIMONA TRIFU, Site 0049, Mihnea Manea, Site 0060, ADELA CIOBANU, Site 0050, Laura Cristina Dolis, Site 0062, Traian Barbu, Site 0064, Octavian Vasiliu, Site 0057, Site 0047, Petru Ifteni, Site 0061, Site 0071, Site 0073, Site 0072, Josep Antoni Ramos-Quiroga, Site 0069, Ana Catalan, Site 0039, Eduard Vieta, Site 0044, Andreas Carlborg, Site 0077, Site 0088, Site 0092, Site 0093, Site 0085, Site 0094
Email
Clinical.Trials@bms.com
Phone
855-907-3286, 501-350-3285, 479-927-3000, 424-227-8127, 951300492, 310-523-4200, 954-375-7794, 305-400-0814, 786-512-4106, 305-669-6166, 786-831-7303, 404-881-5800, 404-537-1281, 301-251-4702, 601-420-5810, 314-771-6387, 267-981-8911, 513-404-0279, 330-493-1118, 972-283-6286, 214-396-4844, 3853780732, +38513780678, 38513430020, +972545838725, +972506261093, 0585950299, 972-8-6401463, +972-506262005, +40721243869, +40727818190, 0040731581100, 0040745974029, 0040723671301, 0040757243543, +40723652564, 0040723725815, 0040724993329, +34934894295, 669736802, 932275400, +46(0)8-12341043
Registry
ClinicalTrials.gov
Why this study may matter

Why this study may matter

This study may matter because it is evaluating KarXT, Placebo 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

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.

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Study reference: NCT06951711. 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, Placebo
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 Evaluate the Efficacy and Safety of KarXT for the Treatment of manic episodes in Bipolarity type I (BALSAM-2)?

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.

A Study to Evaluate the Efficacy and Safety of. — Bipolarity Clinical Trial | HopeStage