A Study of Esomeprazole in Children With Autism

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT03866668
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 29, 2019
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2) [ Time Frame: Baseline, 4 Weeks, 8 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305
Robin Libove
[email protected]
(650)736-1235

Find similar trials in Stanford, CA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Stanford University School of Medicine· Stanford, CA

Related Studies