RecruitingPhase 2NCT04060030

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


Sponsor

Southwest Autism Research & Resource Center

Enrollment

80 participants

Start Date

Oct 8, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 MonthsMax Age: 60 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Levoleucovorin Calcium and Placebo for people with autism spectrum disorder and language disorders. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 30 Months to 60 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLevoleucovorin Calcium

Liquid leucovorin calcium dosed by weight

OTHERPlacebo

Placebo


Locations(2)

Southwestern Research & Resource Center

Phoenix, Arizona, United States

State University of New York, Downstate

Brooklyn, New York, United States

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NCT04060030


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