What will happen during this study?
Patients who qualify for this study will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. There is an equal chance of being assigned to either study drug (investigational drug or placebo).
Patients, their parents/caregivers, and the study team will not know which study drug anyone is taking. However, in the event of an emergency, this information can be provided to the study team.
Patients will take their study drug once a day for 8 weeks (2 months). A patient’s total time in this study will last up to 22 weeks, which includes screening for study eligibility, study drug dosing, and follow-up. During those 22 weeks, patients will be asked to come to about 9 study clinic visits for health exams and tests.
What are the benefits and risks related to this study?
Patients may receive some benefit from study participation, but that cannot be guaranteed. However, participation in this study may benefit children and adolescents with ASD and irritability symptoms in the future.
It’s also possible patients could experience one or more side effects during this study. Prior to patients beginning the study, the study staff will review all known study-related risks and side effects with them and their parents/caregivers. Additionally, during the study, patients will be closely monitored for any side effects and changes in their health.