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

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment this month; Phase 3

Conditions: Irritability Associated With Autism Spectrum Disorder

Treatments: Drug: KarXT; Drug: KarX-EC; Drug: KarXT + KarX-EC Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07285798

CN012-0045

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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176 participants in 2 patient groups

KarXT + KarX-EC Arm

Experimental group

Treatment:

Drug: KarX-EC

Drug: KarXT

Placebo

Experimental group

Treatment:

Drug: KarXT + KarX-EC Matching Placebo