Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
NCT04060030
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Autism Spectrum Disorder
- Language Disorders
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 30 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Southwest Autism Research & Resource Center
- Last updated on ClinicalTrials.gov
- April 27, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
New York · 1
- State University of New York, Downstate · Brooklyn, NY
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.