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.
