A Study of Esomeprazole in Children With Autism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-6
SponsorStanford University
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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
Treatments tested in this trial
- Esomeprazole
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Stanford University
Lead sponsor
SPARK (Stanford University)
Collaborator
Source ClinicalTrials.gov