A Study of Esomeprazole in Children With Autism

ConditionsAutism Autism Spectrum Disorder

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age2-6

SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: EsomeprazoleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

Baseline, 4 Weeks, 8 Weeks

Secondary outcomes

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.

Time frame

Baseline, 4 Weeks, 8 Weeks

Other outcomes

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

Time frame

Baseline, 4 Weeks, 8 Weeks

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

Time frame

Baseline, 4 Weeks, 8 Weeks

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

Time frame

Baseline, 4 Weeks, 8 Weeks

Change from Baseline on the Vineland Adaptive Behavoir Scales - 3 (VABS-3)

Time frame

Baseline, 4 Weeks, 8 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

SPARK (Stanford University)

Collaborator

Source ClinicalTrials.gov

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