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:

• Your child has been diagnosed with Autism Spectrum Disorder (confirmed through specific standard diagnostic tests called the ADOS-2 or ADI-R)
• Your child is between 2 years 6 months and 5 years 2 months old at the start of the study
• Your child has tested positive for a specific type of antibody that affects folate (a B vitamin) reaching the brain (called Folate Receptor Alpha Autoantibody positive)
• Your child has a language delay, based on a standard developmental questionnaire
• English is one of the languages your child is being raised with
• Your child has a moderate or higher level of autism severity, as rated by the study doctor using a standard scale
• You are able to keep all current therapies, diets, and treatments unchanged for the entire study period
• Your child's current therapies, diets, and treatments have already been unchanged for at least two months before joining the study
• Your child shows at least a basic level of early communication, such as voluntary babbling (for example, saying "bu, bu, bu"), confirmed by a parent on a standard developmental checklist
• Your child is able to pay attention to social cues and can tolerate the imaging procedures used in this study, as decided by the study doctor

Who may not be able to join:

• Your child has already had their Folate Receptor Alpha Autoantibody status confirmed through a standard clinical (non-research) test
• Your child is taking vitamin or mineral supplements at levels above the daily upper limits set by the Institute of Medicine (confirm with trial site for specific limits)
• Your child shows significant self-harming, violent behavior, or any signs of thoughts of suicide
• Your child is rated as "extremely ill" (the highest severity level) on the study doctor's standard rating scale
• Your child was born very prematurely (before 34 weeks of pregnancy)
• Your child currently has uncontrolled acid reflux
• Your child has a current or past history of liver or kidney disease
• Your child has a genetic syndrome
• Your child has a structural brain abnormality present from birth
• Your child has epilepsy
• Your child has any other medical condition that the study doctor believes could put them at risk or affect the study results
• Your child has had a significant bad reaction to a blood draw in the past, such as fainting or vomiting
• Your child is not gaining weight as expected, or their weight or body mass index falls below the 5th percentile for their age (confirm with trial site for specific weight details)
• Your child is currently taking certain medications that could interact with the study drug, including some chemotherapy, anti-malaria, immune-suppressing, or antibiotic medicines (confirm with trial site for specific medicines)
• Your child has a known allergy or sensitivity to any ingredient in the study drug or the placebo (inactive treatment)
• Your child has had certain specific developmental assessments (called MSEL or BOSCC) within the 3 months before joining the study
• Your child is expected to have those same assessments during the study period
• Your child has any metal implants, metal attached to the body (including hair extensions), a head circumference over 60 cm, or weighs more than 407 lbs (185 kg) — these factors affect eligibility for the brain-scanning part of the study

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