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 NCT07424404
Run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company · for 5 to 17 · All sexes
What this study is about
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
Who can join (things the study team will check)
✅ You may be able to join 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 be able to join 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 this trial is running
- Advanced Research Center Inc., Anaheim, California, United States
- Inland Psychiatric Medical Group., Chino, California, United States
- Local Institution - 0024, Culver City, California, United States
- Local Institution - 0083, Redlands, California, United States
- Local Institution - 0089, San Francisco, California, United States
- Apg Research, Llc, Orlando, Florida, United States
- Atlanta Center for Medical Research, Atlanta, Georgia, United States
- Salveo Integrative Health - Lawrenceville, Lawrenceville, Georgia, United States
- Denali Health Atlanta, LLC, Stone Mountain, Georgia, United States
- EmVenio Research Center - Prime Healthcare, Chicago, Illinois, United States
- Local Institution - 0076, Boston, Massachusetts, United States
- Local Institution - 0059, Worcester, Massachusetts, United States
+ 46 more sites.
Who to contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07424404.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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