Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from the 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 3 and 6 years old
• Children who have been diagnosed with autism spectrum disorder (ASD) based on recognised medical guidelines (called DSM-5)
• Children whose ASD diagnosis was confirmed using a specific, standardised assessment tool (called ADOS-2)
• Children who received their ASD diagnosis at least 6 months before the study screening process begins
• Children whose ASD is not linked to a known genetic condition, chromosomal difference, major birth defect, or identified metabolic or neurological disorder
• Children whose autism symptoms are rated at a certain level of severity or above, as measured by specific clinical scoring tools (CGI-S, ABC-I, and SRS-2) (confirm with trial site)
• Children whose body weight is between approximately 11.45 kg and just under 27 kg

Who may not be able to join:

• Children who have had a seizure, or whose seizure medication has been changed, within the 8 weeks before joining the study
• Children who have significant health problems found during a physical check-up or blood/lab tests, including serious issues with the heart, liver, or kidneys
• Children who have taken a supplement called folinic acid within the 3 months before joining the study
• Children whose medication, behavioural therapy, home environment, or school setting has changed in the 4 weeks before joining — or where such changes are planned during the study
• Children (or families) who are not expected to be able to follow the study procedures reliably
• Children who are taking certain medications that affect how the body processes folate, such as methotrexate or trimethoprim

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