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Trial ID CN012-0045  |   NCT07285798

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 5-17
    Age Range
  • 31
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

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  • 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.
    1. 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

      Exclusion Criteria Icon
      • 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).
        1. 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.
          1. Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
            1. Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
              1. Other protocol-defined Inclusion/Exclusion criteria may apply.
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: KarXT + KarX-EC Arm

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Placebo

                ASSIGNED INTERVENTION
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