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

176 patients around the world

Available in Argentina, United States

Bristol-Myers Squibb

176Patients around the world

This study is for people with

Autism Spectrum Disorder

To 17 Years

All Gender

: 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).

: 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.

SponsorBristol-Myers Squibb

Study typeInterventional

Conditions

Autism Spectrum Disorder

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07284745