Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

Key Inclusion Criteria

• Primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD
• Aberrant Behavior checklist - Irritability (ABC-I) subscale score of ≥ 18
• Clinical Global Impressions - Severity (CGI-S) scale score pertaining to irritability ≥ 4
• Mental age of ≥ 2 years as determined by Investigator based upon school participation, social history or medical records
• Ability for parent/caregiver to follow all protocol procedures
• Able to swallow tablets
• Able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period

Key Exclusion Criteria

• Primary diagnosis of bipolar I disorder, including any DSM-5 current diagnosis of bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode, and post-traumatic stress disorder (PTSD). Attention-deficit/hyperactivity disorder (ADHD) maybe exclusionary if it is the primary disorder, or is not stable or adequately treated.
• current or historical diagnosis of Fragile-X Syndrome or Rett's Disorder
• history of neuroleptic malignant syndrome
• a significant risk of committing violent acts, serious self-harm, or suicide
• epilepsy, a history of seizures, or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions
• current hypothyroidism or hyperthyroidism
• uncontrolled Type I or Type II diabetes
• uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
• Weight < 15 kg
• Previous exposure to brexpiprazole
• Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study