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| Name | Class |
|---|---|
| SPARK (Stanford University) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 4 Weeks, 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 Weeks, 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Raman | Contact | (650)736-1235 | autismdd@stanford.edu | |
| Briana Hernandez | Contact | (650)736-1235 | autismdd@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Hardan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
| 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 |
| Change from Baseline on the Dimensional Assessment of Repetitive Behavior (DARB) | Baseline, 4 Weeks, 8 Weeks |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |