Status:
NOT_YET_RECRUITING
A Study to Evaluate the Effect of KarXT on Urological Safety
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2).
- Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2.
- Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.
- Exclusion Criteria
- Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
- Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study.
- Other protocol-defined Inclusion/Exclusion criteria apply
Exclusion
Key Trial Info
Start Date :
January 21 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07221877
Start Date
January 21 2026
End Date
December 30 2027
Last Update
October 28 2025
Active Locations (16)
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1
Local Institution - 0017
Little Rock, Arkansas, United States, 72204
2
Local Institution - 0007
Bellflower, California, United States, 90706
3
Local Institution - 0009
Culver City, California, United States, 90230
4
Local Institution - 0006
Los Alamitos, California, United States, 90720