Autism Spectrum Disorder (ASD) and Irritability Study for Children and Teens 5 to 17 Years Old
Why are we doing this research?
Cincinnati Children's is conducting a research study, sometimes known as a clinical trial or clinical study, to compare how safe, effective and tolerable a study drug is for managing irritability associated with their Autism Spectrum Disorder (ASD).
Who can participate?
Children and teens 5 to 17 years old who are diagnosed with autism and have symptoms of irritability.
Conditions
- Disabilities: Developmental
- Autism
- Disabilities: Intellectual
- Language/Speech
What will happen in the study?
This study includes 8 visits (2 may be remote visits) over 6 to 14 weeks. Here are some of the things that will happen in this study:
Your child will:
- Be asked for blood and urine samples
- Orally take the study drug called Pimavanserin or the placebo (no active ingredients that looks like the study drug)
- ECG testing (electrocardiogram)– record electrical activity of the heart
You, as the parent or guardian will:
- Help with study requirements
- Take part in certain assessments
- Assess your child’s condition throughout the study
What are the good things that can happen from this research?
Participants may or may not receive any benefit from being in this study. It is possible that the participant may get better, stay the same, or get worse. However the information we get from this study may help other people with similar conditions in the future.
What are the bad things that can happen from this research?
A detailed list of possible risks or discomforts will be provided to those interested in participating or to parents or guardians interested in knowing more about this study.
Will you/your child be paid to be in this research study?
Participants may receive up to $850 for completing all of the visits involved in the study.