NCT03866668

A Study of Esomeprazole in Children With Autism

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Esomeprazole	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

Timeline

• Start date: 2019-05-29
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2019-03-07
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study