Pilot Study of Esomeprazole Treatment for Social Communication in Children Aged 2 to 6 with Autism Spectrum Disorder

What this Trial Is About

Autism Spectrum Disorder ASD is a developmental condition marked by challenges in social behavior and communication, along with repetitive behaviors. Researchers are evaluating Esomeprazole as a potential treatment to improve social communication deficits in children with ASD. This is an open-label Phase 2 study inviting 25 children aged 2 to 6 years to participate over 12 weeks. Participants receive Esomeprazole with dosing based on their weight. Children weighing less than 20 kg take 10 mg once daily for 8 weeks. Those weighing 20 kg or more start with 10 mg once daily for 4 weeks, then increase to 20 mg once daily for another 4 weeks. This dosing schedule is designed to assess the medications effects over the treatment period. During the study, children will be monitored at baseline, 4 weeks, and 8 weeks using assessments like the Social Responsiveness Scale SRS-2 and the Aberrant Behavior Checklist ABC-2 to measure changes in social behaviors and other symptoms. Caregivers provide ratings and attend clinic visits. The study emphasizes stable medication use and consistent psychosocial support during participation, with a total duration of 12 weeks.

A Study of Esomeprazole in Children With Autism