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NCT02839915 · ClinicalTrials.gov registry record · Phase 2
Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder
A Phase 2 study of Autism Spectrum Disorder, sponsored by Southwest Autism Research & Resource Center.
- Active
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 4
- Study locations
NCT02839915 is a Phase 2 study of Autism Spectrum Disorder that is active but no longer recruiting, run by Southwest Autism Research & Resource Center. The registered enrollment target is 56 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (59% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT02839915, a Phase 2 study of Autism Spectrum Disorder, is active but no longer recruiting, sponsored by Southwest Autism Research & Resource Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 4
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 56 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 (59% lower). The listed sponsor is Southwest Autism Research & Resource Center, which has 8 total studies on file at ClinicalTrials.gov.
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.
NCT02839915 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Arizona, Georgia, Massachusetts.
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.
What interventions are being tested in trial NCT02839915?
The interventions under investigation include: Placebo (OTHER), Folinic Acid (DRUG).
Who is sponsoring clinical trial NCT02839915?
This trial is sponsored by Southwest Autism Research & Resource Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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.