Status:
RECRUITING
A Study of Esomeprazole in Children With Autism
Lead Sponsor:
Stanford University
Collaborating Sponsors:
SPARK (Stanford University)
Conditions:
Autism
Autism Spectrum Disorder
Eligibility:
All Genders
2-6 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03866668
Start Date
May 29 2019
End Date
December 1 2028
Last Update
November 12 2025
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305