Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
Study NCT ID:
NCT03866668
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2019-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Esomeprazole in Children With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-08', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ)', 'timeFrame': 'Baseline, 4 Weeks, 8 Weeks'}, {'measure': 'Change from Baseline on the Repetitive Behavoiors Scale- Revised (RBS-R)', 'timeFrame': 'Baseline, 4 Weeks, 8 Weeks'}, {'measure': 'Change from Baseline on the Stanford Social Motivation Scale (SSMS)', 'timeFrame': 'Baseline, 4 Weeks, 8 Weeks'}, {'measure': 'Change from Baseline on the Vineland Adaptive Behavoir Scales - 3 (VABS-3)', 'timeFrame': 'Baseline, 4 Weeks, 8 Weeks'}, {'measure': 'Change from Baseline on the Dimensional Assessment of Repetitive Behavior (DARB)', 'timeFrame': 'Baseline, 4 Weeks, 8 Weeks'}], 'primaryOutcomes': [{'measure': 'Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)', 'timeFrame': 'Baseline, 4 Weeks, 8 Weeks', 'description': 'Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2)', 'timeFrame': 'Baseline, 4 Weeks, 8 Weeks', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esomeprazole'], 'conditions': ['Autism', 'Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* outpatients 2 to 6 years of age;\n* males and females who are physically healthy;\n* 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)\n* care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;\n* ability of subject to swallow the compound;\n* stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);\n* no planned changes in psychosocial interventions during the open-label trial.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;\n* prior adequate trial of Esomeprazole;\n* active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).'}, 'identificationModule': {'nctId': 'NCT03866668', 'briefTitle': 'A Study of Esomeprazole in Children With Autism', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'An Open-Label Pilot Study of Esomeprazole in Children With Autism', 'orgStudyIdInfo': {'id': 'IRB-44589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esomeprazole', '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', 'interventionNames': ['Drug: Esomeprazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], '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', 'armGroupLabels': ['Esomeprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robin Libove', 'role': 'CONTACT', 'email': 'rlibove@stanford.edu', 'phone': '(650)736-1235'}], 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Nina Raman', 'role': 'CONTACT', 'email': 'autismdd@stanford.edu', 'phone': '(650)736-1235'}, {'name': 'Briana Hernandez', 'role': 'CONTACT', 'email': 'brianah@stanford.edu', 'phone': '(650)736-1235'}], 'overallOfficials': [{'name': 'Antonio Hardan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'SPARK (Stanford University)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Hardan', 'investigatorAffiliation': 'Stanford University'}}}}