A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents
NCT ID: NCT07288567
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
166 participants
INTERVENTIONAL
2026-01-27
2029-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KarXT
KarXT
Specified dose on specified days
Placebo
KarXT Matching Placebo
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
KarXT Matching Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
* Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).
Exclusion Criteria
* History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
* All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.
* Any neurological disorder, except for Tourette's Syndrome.
* Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.
13 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0077
Anaheim, California, United States
Local Institution - 0058
Chino, California, United States
Local Institution - 0089
San Francisco, California, United States
Local Institution - 0032
Orlando, Florida, United States
Local Institution - 0057
Atlanta, Georgia, United States
Local Institution - 0106
Lawrenceville, Georgia, United States
Local Institution - 0039
Stone Mountain, Georgia, United States
Local Institution - 0044
Chicago, Illinois, United States
Local Institution - 0107
Evanston, Illinois, United States
Local Institution - 0076
Boston, Massachusetts, United States
Local Institution - 0100
Brookline, Massachusetts, United States
Local Institution - 0059
Worcester, Massachusetts, United States
Local Institution - 0049
Highland Park, Michigan, United States
Local Institution - 0061
Great Neck, New York, United States
Local Institution - 0051
Cincinnati, Ohio, United States
Local Institution - 0099
Philadelphia, Pennsylvania, United States
Local Institution - 0046
Garland, Texas, United States
Local Institution - 0090
McAllen, Texas, United States
Local Institution - 0066
Spring, Texas, United States
Local Institution - 0050
Richmond, Virginia, United States
Local Institution - 0009
Pereira, Risaralda Department, Colombia
Local Institution - 0001
Barranquilla, , Colombia
Local Institution - 0020
Bogotá, , Colombia
Local Institution - 0075
Chikugo-Shi, Fukuoka, Japan
Local Institution - 0073
Sapporo, Hokkaido, Japan
Local Institution - 0025
Zentsujichó, Kagawa-ken, Japan
Local Institution - 0062
Miyakonojō, Miyazaki, Japan
Local Institution - 0086
Bunkyo-ku, Tokyo, Japan
Local Institution - 0056
Ōta-ku, Tokyo, Japan
Local Institution - 0063
Yokohama, Kanagawa, , Japan
Local Institution - 0029
Bucharest, București, Romania
Local Institution - 0031
Brasov, , Romania
Local Institution - 0040
Bucharest, , Romania
Local Institution - 0042
Bucharest, , Romania
Local Institution - 0008
Iași, , Romania
Local Institution - 0030
Sibiu, , Romania
Local Institution - 0005
Timișoara, , Romania
Local Institution - 0038
Timișoara, , Romania
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Site 0077
Role: primary
Site 0058
Role: primary
Site 0089
Role: primary
Site 0032
Role: primary
Site 0057
Role: primary
Site 0106
Role: primary
Site 0039
Role: primary
Site 0044
Role: primary
Site 0107
Role: primary
Site 0076
Role: primary
Site 0100
Role: primary
Site 0059
Role: primary
Site 0049
Role: primary
Site 0061
Role: primary
Site 0051
Role: primary
Site 0099
Role: primary
Site 0046
Role: primary
Site 0090
Role: primary
Site 0066
Role: primary
Site 0050
Role: primary
Site 0009
Role: primary
Site 0001
Role: primary
Site 0020
Role: primary
Site 0075
Role: primary
Site 0073
Role: primary
Site 0025
Role: primary
Site 0062
Role: primary
Site 0086
Role: primary
Site 0056
Role: primary
Site 0063
Role: primary
Site 0029
Role: primary
Site 0031
Role: primary
Site 0040
Role: primary
Site 0042
Role: primary
Site 0008
Role: primary
Site 0030
Role: primary
Site 0005
Role: primary
Site 0038
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-523711-11-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1325-9936
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0020
Identifier Type: -
Identifier Source: org_study_id
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