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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 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 99 participants.

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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.

Interventions

  • DRUG Folinic Acid
  • DRUG Folinic Acid and placebo

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2012-05
Est. Completion 2015-11
Phase Phase 2

Sponsor

University of Arkansas

318 total trials

What the Registry Record Tells You About NCT01602016

The ClinicalTrials.gov registry entry for NCT01602016 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Folinic Acid is the first listed.

NCT01602016 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.