NCT07284745 · Bristol-Myers Squibb
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
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.
View original scientific description
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Interventions
DRUG
KarXT
Specified dose on specified days
DRUG
KarX-EC
Specified dose on specified days
DRUG
KarXT + KarX-EC Matching Placebo
Specified dose on specified days
Primary outcome measures
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Time frame: Week 8
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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
- Dothan, Alabama
- Phoenix, Arizona
- Anaheim, California
- Glendale, California
- Redlands, California
- San Rafael, California
- Colorado Springs, Colorado
- Boca Raton, Florida
- Gainesville, Florida
- Virginia Gardens, Florida
- Peachtree Corners, Georgia
- Chicago, Illinois
And 18 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2026 · Source of record for eligibility and locations