This clinical research study is evaluating the safety, tolerability, and effectiveness of an investigational medication combination. The main goal of this study is to see if the investigational treatment can safely and effectively help manage symptoms of irritability—such as severe tantrums and physical aggression—to ultimately improve daily life and well-being for children and adolescents living with autism spectrum disorder (ASD).
Participation involves an initial screening period to ensure the study is a safe fit, followed by a treatment period during which participants receive study-related treatment, and a final safety follow-up period. Qualified participants who complete the initial study may also have the opportunity to transition into a longer-term safety extension study.
