Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
NCT ID: NCT06572449
Last Updated: 2025-04-02
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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COMPLETED
PHASE3
173 participants
INTERVENTIONAL
2024-10-28
2025-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KarXT on empty stomach and with food
KarXT
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline.
* Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.
* Willing and able to discontinue all antipsychotic medications prior to baseline visit.
Exclusion Criteria
* Any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
* History of treatment resistance to schizophrenia medications.
* History of allergy/hypersensitivity to KarXT.
18 Years
65 Years
ALL
No
Sponsors
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Karuna Therapeutics
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 - 0002
Los Alamitos, California, United States
Local Institution - 0004
Riverside, California, United States
Local Institution - 0006
Hollywood, Florida, United States
Local Institution - 0005
Atlanta, Georgia, United States
Local Institution - 0003
Decatur, Georgia, United States
Local Institution - 0001
Marlton, New Jersey, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0048
Identifier Type: -
Identifier Source: org_study_id
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