MedTrace Logo

A Study of Esomeprazole in Children With Autism

NCT03866668 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-11-12

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

Principal Investigators

  • Antonio Hardan, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866668 on ClinicalTrials.gov