Phase 3 Autism Spectrum Disorder Trial, Recruiting NCT05664789 Sponsor: Stanford University Condition: Autism Spectrum Disorder
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Phase 3 Autism Spectrum Disorder Trial, Recruiting

NCT05664789
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children aged between 3 years and 12 years and 11 months old
  • Children who have been formally diagnosed with autism spectrum disorder using specific standardised diagnostic tools
  • Children whose repetitive or rigid behaviours are at least moderately severe, as measured by a specific scoring tool used in autism research
  • Children who have not yet started puberty, based on standard physical development guidelines
  • Children whose family lives within 300 miles of the main study location may need to pass a safety screening for MRI scanning and attempt a brain scan at the start of the study; children living further away do not need to do this
  • Children who have been on a stable medication routine for at least 30 days and a stable behavioural or therapy program for at least 60 days before joining, with no planned changes during the trial

Who may not be able to join:

  • Children who have a known genetic condition linked to autism, such as Fragile X syndrome
  • Children who have ever been diagnosed with a serious psychiatric condition, such as schizophrenia
  • Children who have significant ongoing medical problems
  • Children whose primary caregiver is not able to speak and read English well enough to participate
  • Children who are currently taking glutathione supplements or related compounds
  • Children who have previously had a bad reaction to glutathione supplements or related compounds
  • Children who are unable to drink a sample of the study substance mixed into a liquid

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: John Hegarty, PhD, Stanford University

Phone: (650)723-7845

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
26 April 2023
Est. completion
31 January 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Children's Yale Brown-Obsessive Compulsive Scale for Autism Spectrum Disorder (CYBOCS-ASD) at 12 weeks; Change in Glutamatergic neurometabolites at 12 weeks

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov