A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
Bristol-Myers Squibb
Summary
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Eligibility
- Age range
- 5–17 years
- Sex
- All
- Healthy volunteers
- No
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 d…
Interventions
- DrugKarXT
Specified dose on specified days
- DrugKarX-EC
Specified dose on specified days
- DrugKarXT + KarX-EC Matching Placebo
Specified dose on specified days
Locations (45)
- Local Institution - 0036Dothan, Alabama
- Local Institution - 0236Phoenix, Arizona
- Local Institution - 0031Anaheim, California
- Local Institution - 0092Chino, California
- Local Institution - 0257Glendale, California
- Local Institution - 0181San Rafael, California