Overview

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

Status:
Not yet recruiting
Trial end date:
2020-12-01
Target enrollment:
25
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborator:
SPARK (Stanford University)
Treatments:
Esomeprazole
Criteria
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).