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NCT04060017 · ClinicalTrials.gov registry record · Phase 2

Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium

A Phase 2 study of Autism Spectrum Disorder and Language Disorders, sponsored by Southwest Autism Research & Resource Center.

Recruiting
Registry status
Phase 2
Development phase
80
Enrollment target
2
Study locations

NCT04060017 is a Phase 2 study of Autism Spectrum Disorder and Language Disorders that is actively recruiting participants, run by Southwest Autism Research & Resource Center. The registered enrollment target is 80 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04060017, a Phase 2 study of Autism Spectrum Disorder and Language Disorders, is actively recruiting participants, sponsored by Southwest Autism Research & Resource Center.

RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target
2
Study locations

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 language 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 language delays or impairments. Participation will last approximately 26 weeks from screening to end of treatment.

Conditions Studied

Autism Spectrum Disorder Language Disorders

Interventions

  • OTHER Placebo
  • DRUG Levoleucovorin Calcium

Study Locations (2)

Arizona

  • Southwestern Autism Research & Resource Center - Phoenix

New York

  • State University of New York, Downstate - Brooklyn

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2020-09-22
Est. Completion 2026-06
Phase Phase 2

Sponsor

Southwest Autism Research & Resource Center

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04060017

The ClinicalTrials.gov registry entry for NCT04060017 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (41% lower). The listed sponsor is Southwest Autism Research & Resource Center, which has 8 total studies on file at ClinicalTrials.gov.

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.

NCT04060017 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, New York.

Frequently Asked Questions

What is clinical trial NCT04060017 about?

NCT04060017 is a clinical study titled "Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium". 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 language as well as the core and associated symptoms of ASD. The investigators will enroll 80 c...

What is the current status of trial NCT04060017?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2020-09-22. Estimated completion is 2026-06.

What conditions does trial NCT04060017 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Language Disorders.

What interventions are being tested in trial NCT04060017?

The interventions under investigation include: Placebo (OTHER), Levoleucovorin Calcium (DRUG).

Who is sponsoring clinical trial NCT04060017?

This trial is sponsored by Southwest Autism Research & Resource Center, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04060017 being conducted?

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

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.