Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).
- Participants must have a PANSS total score between 80 and 120, inclusive.
- Participants must have a CGI-S score of ≥ 4.
- Exclusion Criteria
- Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
- Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.
- Participants must not have any history or presence of clinically significant medical conditions.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 23 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06882785
Start Date
June 10 2025
End Date
August 23 2029
Last Update
December 18 2025
Active Locations (55)
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1
Hotei Hospital
Kōnan, Aichi-ken, Japan, 4838248
2
Local Institution - 0056
Nagoya, Aichi-ken, Japan, 466-8560
3
Okehazama Hospital
Toyoake, Aichi-ken, Japan, 470-1168
4
Fujita Health University
Toyoake, Aichi-ken, Japan, 470-1192