A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

Recruiting now · Phase 3

Conditions studied: Schizophrenia, Autism-Related Irritability

In brief

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Key facts

Study ID

NCT07424404

Run by

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

People needed

400

Starts

2026-04-07

Expected to finish

2030-03-08

Last updated by the study team

2026-07-20

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

You may not qualify if…

• Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
• Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
• Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)
• VAST Clinical Research — Garland, Texas, United States (enrolling)
• EmVenio Research Center - Prime Healthcare — Chicago, Illinois, United States (enrolling)
• Salveo Integrative Health - Lawrenceville — Lawrenceville, Georgia, United States (enrolling)
• Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry — Cluj-Napoca, Romania (enrolling)
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States (enrolling)
• Goryokai Medical Corporation - Goryokai Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Advanced Research Center Inc. — Anaheim, California, United States (enrolling)
• Inland Psychiatric Medical Group. — Chino, California, United States (enrolling)
• Denali Health Atlanta, LLC — Stone Mountain, Georgia, United States (enrolling)
• Apg Research, Llc — Orlando, Florida, United States (enrolling)
• Emergency Clinical Hospital For Children Louis Turcanu Timis — Timișoara, Romania (enrolling)
• Local Institution - 0145 — Boca Raton, Florida, United States
• Local Institution - 0154 — New Haven, Connecticut, United States
• Local Institution - 0162 — Glendale, California, United States
• Local Institution - 0161 — Colorado Springs, Colorado, United States
• Local Institution - 0076 — Boston, Massachusetts, United States
• Local Institution - 0157 — San Rafael, California, United States
• Local Institution - 0024 — Culver City, California, United States
• Local Institution - 0089 — San Francisco, California, United States
• Local Institution - 0083 — Redlands, California, United States
• Local Institution - 0166 — Orange City, Florida, United States
• Local Institution - 0168 — Hollywood, Florida, United States
• Local Institution - 0158 — Orange, California, United States
• Local Institution - 0164 — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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