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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 Croatia, India, Israel, Italy, Romania, Slovakia, Spain, Sweden, Ukraine, and the United States.

BipolarityOtherFrom 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.

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
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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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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 Croatia.

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
observational follow-up
Time commitment
long follow-up or multiple visits
Study phase
Not available
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 observational follow-up 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 observational follow-up, study visits, and assessments. The time commitment is long follow-up or multiple visits. The study phase is not available in HopeStage data. Check the official source record to see whether a phase is listed. 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