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RECRUITING Phase 2

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

NCT04060030 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER Placebo
  • DRUG Levoleucovorin Calcium

Study Locations (2)

Arizona

  • Southwestern Research & Resource Center — Phoenix

New York

  • State University of New York, Downstate — Brooklyn

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2020-10-08
Est. Completion 2026-06
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04060030

The ClinicalTrials.gov registry entry for NCT04060030 describes a study currently listed as 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 80 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 2 conditions, 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: NCT04060030 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Arizona, New York. 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 NCT04060030 about?

NCT04060030 is a clinical study titled "Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism". 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...

What is the current status of trial NCT04060030?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2020-10-08. Estimated completion is 2026-06.

What conditions does trial NCT04060030 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Language Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04060030?

The interventions under investigation include: Placebo (OTHER), Levoleucovorin Calcium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04060030?

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 NCT04060030 being conducted?

This trial has 2 study locations across Arizona, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial