Clinical trial NCT03866668: A Study of Esomeprazole in Children with Autism
Official title: An Open-Label Pilot Study of Esomeprazole in Children with Autism
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Autism
Autism Spectrum Disorder
Keywords: Esomeprazole
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: SPARK (Stanford University)
First posted: 2019-03-07
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)
timeFrame: Baseline, 4 Weeks, 8 Weeks
Secondary outcomes:
measure: Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2)
timeFrame: Baseline, 4 Weeks, 8 Weeks
Other outcomes:
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
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Antonio Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References: