A Study of Esomeprazole in Children With Autism

NCT03866668 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB-44589
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Esomeprazole

Outcome Measures

Primary Outcomes (1)

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

  Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)

  Baseline, 4 Weeks, 8 Weeks

Secondary Outcomes (1)

• Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2)

  Baseline, 4 Weeks, 8 Weeks

Other Outcomes (5)

• Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ)

  Baseline, 4 Weeks, 8 Weeks

• Change from Baseline on the Repetitive Behavoiors Scale- Revised (RBS-R)

  Baseline, 4 Weeks, 8 Weeks

• Change from Baseline on the Stanford Social Motivation Scale (SSMS)

  Baseline, 4 Weeks, 8 Weeks

Study Arms (1)

Esomeprazole

EXPERIMENTAL

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

Drug: Esomeprazole

Interventions

Esomeprazole DRUG

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

Also known as: Nexium

Esomeprazole

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead
• SPARK (Stanford University): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Antonio Hardan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Raman

CONTACT

(650)736-1235; autismdd@stanford.edu

Briana Hernandez

CONTACT

(650)736-1235; brianah@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: May 29, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)