An Open-Label Pilot Study of Esomeprazole in Children With Autism
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 6 Years (Child)
- Sex
- All
- Accepts 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 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).
Arms & Interventions
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
Intervention: Esomeprazole (Drug)
Outcomes
Primary Outcomes
Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)
Time Frame: 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)
Secondary Outcomes
- Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2)(Baseline, 4 Weeks, 8 Weeks)
Investigators
Antonio Hardan
Principal Investigator
Stanford University