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NCT01602016 · ClinicalTrials.gov registry record · Phase 2
A Folinic Acid Intervention for Autism Spectrum Disorders
A Phase 2 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT01602016: Clinical Trial Phase 2 study, sponsored by University of Arkansas.
NCT01602016 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01602016, a Phase 2 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment (there is no compensation for this visit). If language impairment is verified in the phase 1 screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12 weeks of folinic acid or an inactive placebo, in addition to several evaluations of your child's abilities and a single blood test. Children that complete phase 2 will be eligible for a 12 week open-label trial of folinic acid which is phase 3.
Primary Outcome
Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.
Interventions
- DRUG Folinic Acid
- DRUG Folinic Acid and placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
Why NCT01602016 stopped before completion
NCT01602016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Folinic Acid is the first listed.
NCT01602016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01602016 about?
NCT01602016 is a clinical study titled "A Folinic Acid Intervention for Autism Spectrum Disorders". Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment (there is no compensation for...
What is the current status of trial NCT01602016?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2012-05. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01602016?
The interventions under investigation include: Folinic Acid (DRUG), Folinic Acid and placebo (DRUG).
Who is sponsoring clinical trial NCT01602016?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01602016's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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