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Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder

NCT02839915 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-04-27

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness of folinic acid in the treatment of language problems in children with autism spectrum disorder. Folinic acid, also known as leucovorin, is approved by the U.S. Food and Drug Administration (FDA) to decrease side effects during cancer chemotherapy. Folinic acid may be helpful in treating language problems in children with autism spectrum disorder, but this is not known. Therefore, folinic acid is an investigational new drug for this study. Investigators will enroll a total of 134 participants across all three centers, over a 5 year period and participation will last between 12 and 24 weeks.

Conditions

Interventions

DRUG

Folinic Acid

Liquid levo-leucovorin via oral route. L-leucovorin is the active isomer.

OTHER

Placebo

Inactive placebo comparator

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Harvard University

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2024-04-15
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02839915 on ClinicalTrials.gov