NCT03866668RecruitingPhase 2
A Study of Esomeprazole in Children With Autism
An Open-Label Pilot Study of Esomeprazole in Children With Autism
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 5 Mar 2019
- Start date
- 29 May 2019
- Primary completion date
- Dec 2028
- Lead sponsor
- Stanford University
- Diseases
- Autism
- NCT number
- NCT03866668
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 29 May 2019 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior adequate trial of Esomeprazole;
- taking concomitant medications that interact with the study drug.
Other illness
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;
- active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology);
- history of hypersensitivity to benzimidazole;
Other
- recent or planned hospitalizations;
Who the study is looking for
- outpatients 2 to 6 years of age at time of consent;
- males and females who are physically healthy;
- diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, and confirmed using the Autism Diagnostic Interview-Revised, and the Autism Diagnostic Observation Schedule or Childhood Autism Rating Scale second edition (CARS-2)
- care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;
- ability of subject to swallow the compound;
- stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);
- no planned changes in psychosocial interventions during the open-label trial.
Age in the registry: 2 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.