A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder

To join this study, children and teenagers must be between 5 and 17 years old and have an official diagnosis of autism. They also need to be experiencing noticeable irritability, which medical staff will measure using specific questionnaires and ratings.

There are also some reasons why someone might not be able to join. For example, if they have other serious mental health conditions like bipolar disorder or schizophrenia, they wouldn't be eligible. However, if a child also has ADHD (attention deficit/hyperactivity disorder) and it's well-managed and stable, they might still be able to take part.

It's also important that participants don't have any major medical illnesses that could put them at risk, or problems with their blood test results. The doctors will check for any risk of suicidal thoughts. There might be some other specific rules depending on the study, which the medical team will explain.

If you decide to take part, your child will be given either the new medication combination (KarXT + KarX-EC) or a placebo (a dummy pill with no medicine). You won't know which one they are receiving. Your child will have regular visits to the clinic where doctors and nurses will do assessments to see how they are feeling and if the medication is helping with irritability. These assessments will involve discussions and questionnaires. They will also have physical checks and blood tests to make sure they are safe. Throughout the study, your child will be carefully monitored. The total duration of participation, including all follow-up appointments, will be clearly explained by the study team.