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).