A Study of Esomeprazole in Children With Autism
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2) [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 Outcome Measures
- Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2) [Baseline, 4 Weeks, 8 Weeks]
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.
Other Outcome Measures
- Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ) [Baseline, 4 Weeks, 8 Weeks]
- Change from Baseline on the Repetitive Behavoiors Scale- Revised (RBS-R) [Baseline, 4 Weeks, 8 Weeks]
- Change from Baseline on the Stanford Social Motivation Scale (SSMS) [Baseline, 4 Weeks, 8 Weeks]
- Change from Baseline on the Vineland Adaptive Behavoir Scales - 3 (VABS-3) [Baseline, 4 Weeks, 8 Weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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outpatients 2 to 6 years of age;
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males and females who are physically healthy;
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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;
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care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;
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ability of subject to swallow the compound;
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stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);
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no planned changes in psychosocial interventions during the open-label trial.
Exclusion Criteria:
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DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;
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prior adequate trial of Esomeprazole;
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active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
- SPARK (Stanford University)
Investigators
- Principal Investigator: Antonio Hardan, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-44589