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Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder
NCT02839915 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Placebo
- DRUG Folinic Acid
Study Locations (4)
Arizona
- Southwestern Research and Resource Center — Phoenix
Georgia
- Children's Healtcare of Atlanta — Atlanta
Massachusetts
- Harvard University — Lexington
New York
- State University of New York, Downstate — Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02839915
The ClinicalTrials.gov registry entry for NCT02839915 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Southwest Autism Research & Resource Center, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02839915 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Arizona, Georgia, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02839915 about?
NCT02839915 is a clinical study titled "Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder". 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 chemo...
What is the current status of trial NCT02839915?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2020-08-13. Estimated completion is 2025-12.
What conditions does trial NCT02839915 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02839915?
The interventions under investigation include: Placebo (OTHER), Folinic Acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02839915?
This trial is sponsored by Southwest Autism Research & Resource Center, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02839915 being conducted?
This trial has 4 study locations across Arizona, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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