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A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder - CN012-0045
Atualizado: 10 dezembro, 2025 | ClinicalTrials.gov
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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.
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