Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT06572449

Run by

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

People needed

173

Starts

2024-10-28

Expected to finish

2025-03-13

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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