Phase 2 Autism Spectrum Disorder Trial, Recruiting NCT03866668 Sponsor: Stanford University Condition: Autism Spectrum Disorder
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Phase 2 Autism Spectrum Disorder Trial, Recruiting

NCT03866668
Recruiting Phase 2

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 between 2 and 6 years old who are seen as outpatients (not staying overnight in hospital)
  • Boys and girls who are in generally good physical health
  • Children who have been diagnosed with autism spectrum disorder, confirmed through clinical assessment using recognised diagnostic tools (the ADI-R, ADOS, or CARS-2)
  • Children whose caregiver is able to bring them to clinic appointments regularly, provide reliable observations about the child's behaviour, and spends regular time with the child
  • Children who are able to swallow the study medication
  • Children whose current medications have remained unchanged for at least 2 weeks before the trial begins (or at least 4 weeks if the child is taking fluoxetine)
  • Children whose caregivers do not plan to make changes to any behavioural or psychological therapies during the trial period

Who may not be able to join:

  • Children who have a diagnosis of schizophrenia, schizoaffective disorder, or a similar psychotic disorder
  • Children who have previously had an adequate course of treatment with the medication Esomeprazole
  • Children with unstable seizures or significant ongoing physical health conditions, such as serious liver or kidney problems

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 27 July 2026
Phase 2: approximately ~30% 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: Antonio Hardan, MD, Stanford University

Phone: (650)736-1235

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 2
Registry
ClinicalTrials.gov
Start date
29 May 2019
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)

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: 27 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