Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder (NCT02839915)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Southwestern Research and Resource Center — Phoenix, Arizona
Age range: 5 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Southwestern Research and Resource Center — Phoenix, Arizona
- Children's Healtcare of Atlanta — Atlanta, Georgia
- Harvard University — Lexington, Massachusetts
- State University of New York, Downstate — Brooklyn, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Autism Spectrum Disorder
- Improving the Part C Early Intervention Service Delivery System for Children With ASD — Chicago, Illinois
- Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism — Philadelphia, Pennsylvania
- Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder — New Haven, Connecticut
- PRISM Intervention Study — Los Angeles, California
- ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD) — Dothan, Alabama
- MTT for Children With ASD Who Have Gastrointestinal Disorders — Tempe, Arizona
Explore by condition: All Autism Spectrum Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.