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Completed
NCT06572449
Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
Conditions: Schizophrenia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 173
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Location: Local Institution - 0002 Los Alamitos California
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 Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT06572449). StuddyBuddy aggregates publicly available trial information.