Back to resultsA Study of Esomeprazole in Children With Autism
Primary Purpose
Autism, Autism Spectrum Disorder
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Esomeprazole
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;
- 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).
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Esomeprazole
Arm Description
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
Outcomes
Primary Outcome Measures
Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)
Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
Secondary Outcome Measures
Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2)
Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.
Full Information
NCT ID
NCT03866668
First Posted
March 5, 2019
Last Updated
March 2, 2023
Sponsor
Stanford University
Collaborators
SPARK (Stanford University)
1. Study Identification
Unique Protocol Identification Number
NCT03866668
Brief Title
A Study of Esomeprazole in Children With Autism
Official Title
An Open-Label Pilot Study of Esomeprazole in Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Temporarily stopped due to COVID-19 pandemic.
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
SPARK (Stanford University)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder
Keywords
Esomeprazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)
Description
Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
Time Frame
Baseline, 4 Weeks, 8 Weeks
Secondary Outcome Measure Information:
Title
Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2)
Description
Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.
Time Frame
Baseline, 4 Weeks, 8 Weeks
Other Pre-specified Outcome Measures:
Title
Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ)
Time Frame
Baseline, 4 Weeks, 8 Weeks
Title
Change from Baseline on the Repetitive Behavoiors Scale- Revised (RBS-R)
Time Frame
Baseline, 4 Weeks, 8 Weeks
Title
Change from Baseline on the Stanford Social Motivation Scale (SSMS)
Time Frame
Baseline, 4 Weeks, 8 Weeks
Title
Change from Baseline on the Vineland Adaptive Behavoir Scales - 3 (VABS-3)
Time Frame
Baseline, 4 Weeks, 8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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;
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Hardan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Esomeprazole in Children With Autism
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