An Open-Label Pilot 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: Not yet recruiting

Administrative data

• NCT number: NCT03735888
• Other study ID #: IRB-44589
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2018
• Est. completion date: December 2020

Study information

• Verified date: November 2018
• Source: Stanford University
• Contact: Robin Libove
• Phone: (650)736-1235
• Email: rlibove[@]stanford.edu
• 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: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• 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 (oral)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	SPARK (Stanford University)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on Social Responsiveness Scale, 2nd Edition (SRS-2)		Baseline, 4 Weeks, 8 Weeks
Secondary	Change on Aberrant Behavior Checklist, 2nd Edition (ABC-2)		Baseline, 4 Weeks, 8 Weeks