A Study of Esomeprazole in Children With Autism

Study Overview
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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.

Official Title
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An Open-Label Pilot Study of Esomeprazole in Children With Autism

Conditions
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Autism, Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Esomeprazole


Participation Criteria
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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; 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).

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole<br>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<br>* 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<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2) | Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12. | Baseline, 4 Weeks, 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esomeprazole