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

NCT04060030 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Levoleucovorin Calcium

Liquid leucovorin calcium dosed by weight

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Autism Speaks

    collaborator OTHER

  • State University of New York - Downstate Medical Center

    collaborator OTHER

  • Southwest Autism Research & Resource Center

    lead OTHER

Principal Investigators

  • Richard E Frye, MD, PhD · Rossignol Medical Center, Phoenix AZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04060030 on ClinicalTrials.gov