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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: Recruiting Phase 2 study of Autism Spectrum Disorder and Language Disorders, sponsored by Southwest Autism Research & Resource Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mullen Scales of Early Learning: a scale of cognitive abilities across the following domains: gross motor (not a core subscale), visual reception, fine motor, expressive language, and receptive language. Total change in expressive language ability will be measured by the change in the expressive language raw score. The expressive language domain is a 28-item scale with a raw score range of 0-50. Changes in expressive language raw scores will be reported. A higher raw score indicates a higher lev
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT04060017 shows while recruiting
NCT04060017 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.
NCT04060017 reports a single indexed study location in 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.
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 NCT04060017'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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