A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Irritability Associated With Autism Spectrum Disorder

In brief

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Key facts

Study ID

NCT07284745

Run by

Bristol-Myers Squibb

People needed

176

Starts

2026-09-11

Expected to finish

2029-08-06

Last updated by the study team

2026-08-03

Who can join

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

You may qualify 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 qualify 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 it 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
• Local Institution - 0242 — Louisville, Kentucky, United States
• Local Institution - 0160 — Bloomfield Hills, Michigan, United States
• Local Institution - 0220 — Detroit, Michigan, United States
• Local Institution - 0110 — Las Vegas, Nevada, United States
• Local Institution - 0246 — Staten Island, New York, United States
• Local Institution - 0263 — The Bronx, New York, United States
• Local Institution - 0247 — West Chester, Ohio, United States
• Local Institution - 0269 — Danville, Pennsylvania, United States
• Local Institution - 0041 — Dallas, Texas, United States
• Local Institution - 0273 — Plano, Texas, United States
• Local Institution - 0185 — Spring, Texas, United States
• Local Institution - 0074 — Bountiful, Utah, United States
• Local Institution - 0271 — Provo, Utah, United States

Full record on ClinicalTrials.gov

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