Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the cognitive and behavioral effects of
liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine
whether it improves language as well as the core and associated symptoms of ASD. The
investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years,
with confirmed ASD and known language delays or impairments. Participation will last
approximately 26 weeks from screening to end of treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Phoenix Children's Hospital
Collaborators:
New York State Institute for Basic Research State University of New York - Downstate Medical Center United States Department of Defense University of Arizona