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A Study of Esomeprazole in Children With Autism

NCT ID: NCT03866668

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Autism Spectrum Disorder

Keywords

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Esomeprazole

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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).
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SPARK (Stanford University)

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Hardan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nina Raman

Role: CONTACT

Phone: (650)736-1235

Email: [email protected]

Briana Hernandez

Role: CONTACT

Phone: (650)736-1235

Email: [email protected]

Facility Contacts

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Robin Libove

Role: primary

Other Identifiers

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IRB-44589

Identifier Type: -

Identifier Source: org_study_id