Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Esomeprazole in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03866668
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
SPARK (Stanford University)
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

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
Autism Autism Spectrum Disorder Drug: Esomeprazole Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study of Esomeprazole in Children With Autism
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: Nexium




Primary Outcome Measures :
  1. Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2) [ Time Frame: 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 :
  1. Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2) [ Time Frame: 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:
  1. Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ) [ Time Frame: Baseline, 4 Weeks, 8 Weeks ]
  2. Change from Baseline on the Repetitive Behavoiors Scale- Revised (RBS-R) [ Time Frame: Baseline, 4 Weeks, 8 Weeks ]
  3. Change from Baseline on the Stanford Social Motivation Scale (SSMS) [ Time Frame: Baseline, 4 Weeks, 8 Weeks ]
  4. Change from Baseline on the Vineland Adaptive Behavoir Scales - 3 (VABS-3) [ Time Frame: Baseline, 4 Weeks, 8 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866668


Contacts
Layout table for location contacts
Contact: Lakshmi Vrittamani (650) 736-1235 vrittama@stanford.edu
Contact: Robin Libove (650) 736-1235 rlibove@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Lakshmi Vrittamani    650-736-1235    vrittama@stanford.edu   
Contact: Robin Libove    (650)736-1235    rlibove@stanford.edu   
Sponsors and Collaborators
Stanford University
SPARK (Stanford University)
Investigators
Layout table for investigator information
Principal Investigator: Antonio Hardan, MD Stanford University

Layout table for additonal information
Responsible Party: Antonio Hardan, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03866668     History of Changes
Other Study ID Numbers: IRB-44589
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by Antonio Hardan, Stanford University:
Esomeprazole

Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action