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NCT04060030 · ClinicalTrials.gov registry record · Phase 2
Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
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
NCT04060030: Recruiting Phase 2 study of Autism Spectrum Disorder and Language Disorders, sponsored by Southwest Autism Research & Resource Center.
NCT04060030 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04060030, 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 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.
Primary Outcome
Aberrant Behavior Checklist-2, Social Withdrawal Subscale. The ABC is a 58-item parent-reported measure with ratings in the following domains: irritability, social withdrawal, stereotypic behavior, hyperactivity, and inappropriate speech. Each item is rated from 0 (Not a Problem) to 3 (Severe Problem). The raw score will be reported. The total raw score is the sum of the domain raw scores. A higher raw score in any of the domains indicates more severe problems in that domain; a higher total raw
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-10-08 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT04060030 shows while recruiting
NCT04060030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (41% lower).
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.
NCT04060030 reports a single indexed study location in Arizona, New York.
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.
What interventions are being tested in trial NCT04060030?
The interventions under investigation include: Placebo (OTHER), Levoleucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT04060030?
This trial is sponsored by Southwest Autism Research & Resource Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04060030's enrollment target sits among peer trials
80 89th of 224 higher than 126 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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