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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: Active Phase 2 study of Autism Spectrum Disorder, sponsored by Southwest Autism Research & Resource Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Scale title is the "Clinical Evaluation of Language Fundamentals 4" which is abbreviated as CELF-4 as indicated in the title above. Higher Scores indicate better performance. The Minimum Scaled Score is 40 and the Maximum Scaled Score is 160. The CELF-4 will be administered for participants between \> 6.6 and \< 12.5 years of age. The CELF-4 is comprised of 4 subtests intended to identify language problems and can be used to track progress over time. Administration of the CELF takes 30-45 mi
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 |
What the registry record for NCT02839915 still lists
NCT02839915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (59% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT02839915's enrollment target sits among peer trials
56 134th of 224 higher than 89 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.
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