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

Bristol-Myers Squibb (BMS)

Status and phase

Begins enrollment this month

Phase 3

Conditions

Irritability Associated With Autism Spectrum Disorder

Treatments

Drug: KarX-EC

Drug: KarXT + KarX-EC Matching Placebo

Drug: KarXT

Study type

Interventional

Funder types

Industry

Identifiers

CN012-0044

Details and patient eligibility

About

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

Enrollment

176 estimated patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.