Recruiting
Phase 2

Esomeprazole

Sponsor:

Stanford University

Code:

NCT03866668

Conditions

Autism

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Interventions

Esomeprazole

Study Details

Brief summary:

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.

Conditions

Autism

Autism Spectrum Disorder

Study ID

NCT03866668

Start date

May 29, 2019

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • outpatients 2 to 6 years of age;
  • 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 Criteria:

  • DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;
  • prior adequate trial of Esomeprazole;
  • active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Esomeprazole

Esomeprazole Dosage (Weight Less Than 20 kg) -- 10 mg QD for 8 weeks Esomeprazole Dosage (Weight 20 kg or Greater) -- 10 mg QD for 4 weeks followed by 20 mg QD for 4 weeks

Interventions

Esomeprazole

Esomeprazole Dosage (Weight Less Than 20 kg) -- 10 mg QD for 8 weeks Esomeprazole Dosage (Weight 20 kg or Greater) -- 10 mg QD for 4 weeks followed by 20 mg QD for 4 weeks

Primary outcome measure

  • Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2) [ Time Frame: Baseline, 4 Weeks, 8 Weeks ]

Central Contacts and Locations

Central contacts

Nina Raman

(650)736-1235autismdd@stanford.edu

Briana Hernandez

(650)736-1235autismdd@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Nina Raman

(650)736-1235autismdd@stanford.edu

Robin Libove

(650)736-1235rlibove@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Esomeprazole

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-25.