Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
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 social communication 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 social and communication delays. Participation will last
approximately 26 weeks, from screening visit to end of treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Phoenix Children's Hospital
Collaborators:
Autism Speaks New York State Institute for Basic Research State University of New York - Downstate Medical Center University of Arizona