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An Open-Label Pilot Study of Esomeprazole in Children With Autism
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.
Details
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 25 |
| Start date | 2019-05-29 |
| Completion | 2028-12 |
Conditions
- Autism
- Autism Spectrum Disorder
Interventions
- Esomeprazole
Primary outcomes
- Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2) — Baseline, 4 Weeks, 8 Weeks
Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
Countries
United States