A Study of Esomeprazole in Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

An Open-Label Pilot Study of Esomeprazole in Children With Autism

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03866668
• Other study ID #: IRB-44589
• Status: Suspended
• Phase: Phase 2
• Start date: May 29, 2019
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 25
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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).

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	SPARK (Stanford University)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ)		Baseline, 4 Weeks, 8 Weeks
Other	Change from Baseline on the Repetitive Behavoiors Scale- Revised (RBS-R)		Baseline, 4 Weeks, 8 Weeks
Other	Change from Baseline on the Stanford Social Motivation Scale (SSMS)		Baseline, 4 Weeks, 8 Weeks
Other	Change from Baseline on the Vineland Adaptive Behavoir Scales - 3 (VABS-3)		Baseline, 4 Weeks, 8 Weeks
Other	Change from Baseline on the Dimensional Assessment of Repetitive Behavior (DARB)		Baseline, 4 Weeks, 8 Weeks
Primary	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
Secondary	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