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Study ID: NCT06929273. We help you review the study, but cannot decide medical eligibility.
RecruitingNCT06929273
Long-term safety of KarXT in bipolarity type I
This extension study evaluates safety and tolerability in adults with mania or mania with mixed features.
MedicationAges 18–65Multiple countries
Understand this study
What is this study about?
This extension study evaluates the long-term safety and tolerability of KarXT for mania or mania with mixed features in people living with bipolarity type I.
What would I need to do?
Participants receive KarXT in one open-label study group. The registry also lists lithium, valproate and lamotrigine; it does not specify a single medication combination for every participant.
Who could participate?
Adults aged 18–65 may enter after completing the treatment period of a specified parent study, or as newly enrolled participants. New participants must have bipolarity type I with manic or mixed symptoms and meet the symptom thresholds; they must not require hospitalization for acute mania.
- Listed locations
- Glendale, United States · Scottsdale, United States and 153 more locationsSee all locations and recruitment
- Assessment period
- Safety outcomes are assessed up to week 54. This is an outcome window, not a verified appointment schedule or total participation duration.
- Activities
- KarXT medication
- Compensation
- Not specified in the public protocol reviewed.
What to know before participating
Risks and eligibility restrictions
The protocol lists restrictions related to suicidal risk and, for new participants, rapid cycling, serious constipation, urinary or gastric retention, and untreated narrow-angle glaucoma. Other eligibility requirements also apply.
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: July 18, 2025
- Recruitment status
- Recruiting
- Enrollment listed in the registry
- 450
- Sponsor
- Bristol-Myers Squibb
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- United States, Australia, France, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT06929273
- Official title
Show the full 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)
Recruitment & locations
RecruitingGlendale, United States · Scottsdale, United States · Tucson, United States
152 more locations
- Bentonville, United States
- Little Rock, United States
- Rogers, United States
- Anaheim, United States
- Bellflower, United States
- Cerritos, United States
- Chino, United States
- Culver City, United States
- Garden Grove, United States
- La Habra, United States
- Montclair, United States
- Northridge, United States
- Orange, United States
- Riverside, United States
- Santa Ana, United States
- Torrance, United States
- New Haven, United States
- Boynton Beach, United States
- Hallandale, United States
- Hialeah Gardens, United States
- Hollywood, United States
- Miami, United States
- Miami Lakes, United States
- Miami Springs, United States
- St. Petersburg, United States
- Atlanta, United States
- Decatur, United States
- Savannah, United States
- Chicago, United States
- Indianapolis, United States
- Gaithersburg, United States
- Flowood, United States
- St Louis, United States
- Lincoln, United States
- North Las Vegas, United States
- Marlton, United States
- Staten Island, United States
- Charlotte, United States
- Cincinnati, United States
- North Canton, United States
- West Chester, United States
- Austin, United States
- Carrollton, United States
- DeSoto, United States
- Houston, United States
- Irving, United States
- Mansfield, United States
- Richardson, United States
- Wichita Falls, United States
- ABB, Argentina
- Córdoba, Argentina
- Mendoza, Argentina
- Santiago del Estero, Argentina
- St Leonards, Australia
- Brisbane, Australia
- Kazanlak, Bulgaria
- Burgas, Bulgaria
- Haskovo, Bulgaria
- Novi Iskar, Bulgaria
- Pleven, Bulgaria
- Sliven, Bulgaria
- Sofia, Bulgaria
- Vratsa, Bulgaria
- Beijing, China
- Guangzhou, China
- Baoding, China
- Changsha, China
- Nanjing, China
- Xi'an, China
- Chengdu, China
- Tianjin, China
- Ningbo, China
- Zagreb, Croatia
- Gistrup, Denmark
- Glostrup Municipality, Denmark
- Nice, France
- Clermont-Ferrand, France
- Montpellier, France
- Győr, Hungary
- Budapest, Hungary
- Vadodara, India
- Belagavi, India
- Kozhikode, India
- Ludhiana, India
- Madurai, India
- Hyderabad, India
- Kolkata, India
- Mangalore, India
- Hod HaSharon, Israel
- Ness Ziona, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Beersheba, Israel
- Ashkelon, Israel
- Jerusalem, Israel
- Milan, Italy
- Pisa, Italy
- Siena, Italy
- Ancona, Italy
- Genova, Italy
- Kōnan, Japan
- Toyoake, Japan
- Ichikawa, Japan
- Iizuka, Japan
- Kitakyushu, Japan
- Obihiro, Japan
- Sapporo, Japan
- Yokohama, Japan
- Moriguchi, Japan
- Sakai-shi, Japan
- Karatsu-shi, Japan
- Iruma, Japan
- Kumagaya, Japan
- Bunkyo-ku, Japan
- Kodaira, Japan
- tabashi City, Japan
- Fukuoka, Japan
- Kochi, Japan
- Miyazaki, Japan
- Osaka, Japan
- Tokyo, Japan
- Wakayama, Japan
- Yamagata, Japan
- Auckland, New Zealand
- Poznan, Poland
- Warsaw, Poland
- Bialystok, Poland
- Gdansk, Poland
- Rybnik, Poland
- Tuszyn, Poland
- Bucharest, Romania
- Iași, Romania
- Sanpetru /Brasov, Romania
- Košice, Slovakia
- Vranov nad Topľou, Slovakia
- Barcelona, Spain
- Bilbao, Spain
- Nacka, Sweden
- Uppsala, Sweden
- Gothenburg, Sweden
- Smila, Ukraine
- Dnipro, Ukraine
- Skarzhyntsi, Ukraine
- Hlevakha, Ukraine
- Lviv, Ukraine
- Oleksandrivka, Ukraine
- Vinnytsia, Ukraine
- Kropyvnytskyi, Ukraine
- Kyiv, Ukraine
- Odesa, Ukraine
- Poltava, Ukraine
- Ternopil, Ukraine
A listed location does not confirm current availability.
Questions about this study
What is this study about?
This study evaluates the long-term safety 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, lithium, valproate and lamotrigine.
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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