Not Yet Recruiting
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism - CN012-0044
Updated: 9 December, 2025 | ClinicalTrials.gov
Phase
Gender(s)
Age Range
Location(s)
Not Yet Recruiting
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 (C18 on the Irritability subscale of the ABC-I) 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.
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information
466-SE-2100058
