Status:
COMPLETED
Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
Lead Sponsor:
Karuna Therapeutics
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.
Eligibility Criteria
Inclusion
- Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2.
- 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
- History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (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.
- 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
October 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2025
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT06572449
Start Date
October 28 2024
End Date
March 13 2025
Last Update
April 2 2025
Active Locations (6)
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1
Local Institution - 0002
Los Alamitos, California, United States, 90720-3118
2
Local Institution - 0004
Riverside, California, United States, 92506-3257
3
Local Institution - 0006
Hollywood, Florida, United States, 33024
4
Local Institution - 0005
Atlanta, Georgia, United States, 30331