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RECRUITING
NCT04060030
PHASE2

Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism

Sponsor: Southwest Autism Research & Resource Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

30 Months - 60 Months

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2020-10-08

Completion Date

2026-06

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

DRUG

Levoleucovorin Calcium

Liquid leucovorin calcium dosed by weight

OTHER

Placebo

Placebo

Locations (2)

Southwestern Research & Resource Center

Phoenix, Arizona, United States

State University of New York, Downstate

Brooklyn, New York, United States