Phase 2 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 who are between 4 and 12 years old (after their 4th birthday and before their 13th birthday)
• Children who have been diagnosed with autism spectrum disorder (ASD) confirmed using a recognised rating tool called the CARS-2
• Children whose ASD symptoms are rated as moderate or higher on a clinical severity scale used by doctors (called the CGI-S)
• Children who score 18 or above on a specific behavioural assessment that measures irritability and challenging behaviours (called the ABC-I)
• Children who score 66 or above on a standardised social skills assessment (called the SRS-2)

Who may not be able to join:

• Children whose body weight is less than 12.5 kg or 57.5 kg or more
• Children who have been diagnosed, now or in the past, with heart failure, drug addiction, schizophrenia, psychosis, bipolar disorder, PTSD, or major depression — or whose parent or sibling has been diagnosed with schizophrenia
• Children who have had a seizure, or whose seizure medication has been changed, within the 4 months before joining the trial
• Children who have significant abnormal results on physical examination or medical tests, including problems with heart, liver, or kidney function
• Children whose medication, behavioural therapy, home situation, or school situation (not including school holidays) has changed within 4 weeks before joining, or where such changes are planned during the study
• Children who have used any cannabinoid-based products within 4 weeks before joining the trial
• Children who are not expected to be able to follow the study procedures, such as having blood tests (confirm with trial site)
• Children who are currently using opioid medications or alcohol

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