Phase 1 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children between 5 and 12 years of age (up to, but not including, 13 years old)
• Children who have been primarily diagnosed with Autism Spectrum Disorder (ASD) and show signs of irritability
• Children whose irritability symptoms score at or above a certain level on a standard rating scale called the ABC-I (confirm with trial site for exact score requirements)
• Children whose overall condition is rated at a certain level of severity by a doctor using a standard scale called the CGI-S (confirm with trial site for exact score requirements)
• Children whose body weight is within a healthy range for their age and gender, based on standard growth charts
• Children who are able to swallow capsules

Who may not be able to join:

• Children whose main diagnosis is a psychiatric condition other than ASD
• Children who have had thoughts of suicide within the past 6 months, or any suicidal behaviour within the past 2 years, or who the trial doctor considers to be a safety risk to themselves or others
• Children who have had a significant medical condition within the past 2 years that, in the trial doctor's opinion, could put them at risk or affect the results of the study
• Children who have a history of a significant heart condition, or whose heart test (ECG) results are outside the normal range at the time of screening
• Children who have a history of a sudden drop in blood pressure when standing up, or who show this at the time of screening
• Children who have had uncontrolled or disruptive behaviour in the past 30 days that, in the trial doctor's opinion, would prevent them from taking part in study activities

Important: Always verify eligibility with the trial site directly before applying.