NCT03866668 A Study of Esomeprazole in Children With Autism
| NCT ID | NCT03866668 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2019-05-29 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2019-05-29 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Antonio Hardan, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT03866668 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 6 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03866668 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03866668 currently recruiting?
Yes, NCT03866668 is actively recruiting participants. Contact the research team at autismdd@stanford.edu for enrollment information.
Where is the NCT03866668 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT03866668 clinical trial?
NCT03866668 is sponsored by Stanford University. The principal investigator is Antonio Hardan, MD at Stanford University. The trial plans to enroll 25 participants.