Actively Recruiting
An Open-Label Pilot Study of Esomeprazole in Children With Autism
Led by Stanford University · Updated on 2025-11-12
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
S
SPARK (Stanford University)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Esomeprazole to address social communication difficulties in children diagnosed with Autism Spectrum Disorder (ASD). This study focuses on children aged 2 to 6 years and aims to understand how Esomeprazole might impact core symptoms of autism, including social behavior challenges and repetitive behaviors. The trial is a phase 2, 12-week open-label study inviting 25 children to participate. Participants will receive Esomeprazole based on their body weight. Children weighing less than 20 kg will take 10 mg once daily for 8 weeks. Those weighing 20 kg or more will start with 10 mg once daily for 4 weeks, then increase to 20 mg once daily for the next 4 weeks. The study does not include a placebo group, and all participants receive the active medication during the open-label period. Throughout the study, children will be assessed at the start, 4 weeks, and 8 weeks using tools like the Social Responsiveness Scale, 2nd Edition (SRS-2), to measure changes in social communication, and the Aberrant Behavior Checklist, 2nd Edition (ABC-2), to evaluate behavior changes. Caregivers will provide ratings, and children must be able to attend clinic visits regularly. The study includes safety monitoring and aims to collect data on the effects of Esomeprazole over the 12-week period.
CONDITIONS
Brief Title
A Study of Esomeprazole in Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 6 years
- Male or female who are physically healthy
- Diagnosis of autism spectrum disorder confirmed by clinical evaluation and specific diagnostic tools
- Caregiver able to bring child to clinic visits and provide reliable ratings
- Child able to swallow the study medication
- Stable medications for at least 2 weeks (4 weeks if taking fluoxetine)
- No planned changes in psychosocial interventions during the study
You will not qualify if you...
- Diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorders
- Prior adequate trial of Esomeprazole
- Active medical problems such as unstable seizures or serious liver or kidney disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive Esomeprazole medication according to weight-based dosing schedules.
Baseline visit and visits at 4 weeks and 8 weeks
Trial Site Locations
Total: 1 location
1
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
Research Team
N
Nina Raman
B
Briana Hernandez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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