A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
Opening soon Phase 3 NCT07284745
Run by Bristol-Myers Squibb · for 5 to 17 · All sexes
What this study is about
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Who can join (things the study team will check)
✅ You may be able to join if…
- Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
- Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).
🚫 You may not be able to join if…
- Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
- Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
- Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
- Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
- Other protocol-defined Inclusion/Exclusion criteria may apply.
Where this trial is running
- Local Institution - 0036, Dothan, Alabama, United States
- Local Institution - 0236, Phoenix, Arizona, United States
- Local Institution - 0031, Anaheim, California, United States
- Local Institution - 0257, Glendale, California, United States
- Local Institution - 0233, Redlands, California, United States
- Local Institution - 0181, San Rafael, California, United States
- Local Institution - 0252, Colorado Springs, Colorado, United States
- Local Institution - 0264, Boca Raton, Florida, United States
- Local Institution - 0099, Gainesville, Florida, United States
- Local Institution - 0278, Gainesville, Florida, United States
- Local Institution - 0155, Peachtree Corners, Georgia, United States
- Local Institution - 0266, Chicago, Illinois, United States
+ 28 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: NCT07284745.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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