Tests esomeprazole in young children with autism spectrum disorder
Tests esomeprazole for social communication difficulties in children with autism, aged 2 to 6.
Plain-language title generated from the registry record
Registry title: A Study of Esomeprazole in Children With Autism
Key facts
- Where
- Stanford, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 6 years old?
Source: NCT03866668, who can take part
Where in United States
- Stanford University School of MedicineStanford, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stanford University
- Trial code
- NCT03866668
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
An Open-Label Pilot Study of Esomeprazole in Children With Autism
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.
Inclusion: 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.
Exclusion: prior adequate trial of Esomeprazole; taking concomitant medications that interact with the study drug; 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; recent or planned hospitalizations.