A Study of Esomeprazole in Children With Autism

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Autism Spectrum Disorder; Autism

Treatments: Drug: Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03866668

IRB-44589

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Esomeprazole

Experimental group

Description:

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:

Drug: Esomeprazole