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Study ID: NCT06951711. We help you review the study, but cannot decide medical eligibility.
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 evaluates the safety and effectiveness of KarXT for people with bipolarity.
Medication studyAges 18–65Multiple countries
Understand this study
What is this study about?
This study evaluates the safety and effectiveness of KarXT for people with bipolarity.
Who could participate?
This study is for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
- Listed locations
- Little Rock, United States · Rogers, United States and 65 more locationsSee all locations and recruitment
- Activities
- Medication described in the protocol · Placebo comparator
- Compensation
- Payment and expense reimbursement have not been verified.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: June 13, 2025
- Recruitment status
- Recruiting
- Enrollment listed in the registry
- 274
- Sponsor
- Bristol-Myers Squibb
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Medication / drug, OTHER
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- United States, China, Croatia, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT06951711
- 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)
Recruitment & locations
RecruitingLittle Rock, United States · Rogers, United States · Culver City, United States
64 more locations
- Riverside, United States
- Torrance, United States
- Boynton Beach, United States
- Hialeah Gardens, United States
- Hollywood, United States
- Miami, United States
- Miami Lakes, United States
- Miami Springs, United States
- Tampa, United States
- Atlanta, United States
- Decatur, United States
- Chicago, United States
- Gaithersburg, United States
- Flowood, United States
- St Louis, United States
- North Las Vegas, United States
- Marlton, United States
- Charlotte, United States
- Cincinnati, United States
- North Canton, United States
- DeSoto, United States
- Houston, United States
- Richardson, United States
- Beijing, China
- Wuhan, China
- Changsha, China
- Jining Shi, China
- Tianjin, China
- Zagreb, Croatia
- Visakhapatnam, India
- Vadodara, India
- Belagavi, India
- Kozhikode, India
- Ludhiana, India
- Hyderabad, India
- Kolkata, India
- Hod HaSharon, Israel
- Ness Ziona, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Beersheba, Israel
- Jerusalem, Israel
- Milan, Italy
- Pisa, Italy
- Siena, Italy
- Ancona, Italy
- Genova, Italy
- Bucharest, Romania
- Iași, Romania
- Sanpetru /Brasov, Romania
- Košice, Slovakia
- Vranov nad Topľou, Slovakia
- Barcelona, Spain
- Bilbao, Spain
- Nacka, Sweden
- Uppsala, Sweden
- Gothenburg, Sweden
- Dnipro, Ukraine
- Kropyvnytskyi, Ukraine
- Hlevakha, Ukraine
- Oleksandrivka, Ukraine
- Vinnytsia, Ukraine
- Odesa, Ukraine
- Poltava, Ukraine
A listed location does not confirm current availability.
Questions about this study
What is this study about?
This study evaluates the safety and effectiveness of KarXT for people with bipolarity.
Who is behind this study?
The study sponsor is Bristol-Myers Squibb, a pharmaceutical company.
Does this study involve medication?
Yes. The study involves medication, including KarXT.
Who can participate?
This study is for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as recruiting.
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