Clinical Trial TitleInvestigational drug study for adults with autism spectrum disorder.
Clinical Trial Protocol Description:
The study consists of a 24-week double-blind, placebo-controlled treatment period followed by a 2-year open-label extension period for subjects who complete the double-blind treatment period.
The purpose of this study is to compare the effects of an investigational drug and placebo on social behavior and communication in people with autism spectrum disorder. This is a placebo-controlled study; treatment will be assigned randomly. At Rush, we expect to enroll approximately 7 subjects at this site. Approximately 350 subjects will take part in this study at all sites.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have autism spectrum disorder.
- Have an individual who can participate as a study partner.
You will be excluded from the study if any of the following criteria apply to you:
- Are a female who is pregnant or breastfeeding.
- Meet criteria for substance use disorder.
- Have unstable medical condition.
This is a partial list of inclusion and exclusion criteria.