A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-17
SponsorBristol-Myers Squibb
About this trial
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KarXT
- KarX-EC
- KarXT + KarX-EC Matching Placebo
Treatment groups
176 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov