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

Karuna Therapeutics

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: KarXT

Study type

Interventional

Funder types

Industry

Identifiers

NCT06572449

CN012-0048

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.