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Study identifier: NCT04060030 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Autism Spectrum Disorder · Language Disorders  ·  Sponsor: Southwest Autism Research & Resource Center

PhasePhase 2
Planned participants80
Who can joinAll sexes, 30 Months to 60 Months
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Richard E Frye, MD, PhD  ·  (321) 259-7111  ·  DrFrye@RossignolMedicalCenter.com

Always discuss trial participation with your own doctor first.

Locations (2)

Southwestern Research & Resource CenterPhoenix, Arizona, United StatesNot Yet Recruiting
State University of New York, DownstateBrooklyn, New York, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04060030