An Open-Label Pilot Study of Esomeprazole in Children With Autism
Stanford University
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.
Eligibility
- Age range
- 2–6 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugEsomeprazole
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
Location
- Stanford University School of MedicineStanford, California