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NCT02584413 · ClinicalTrials.gov registry record · NA

Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma

A NA study, sponsored by Washington University School of Medicine.

Terminated
Registry status
NA
Development phase
29
Enrollment target

NCT02584413: Clinical Trial NA study, sponsored by Washington University School of Medicine.

NCT02584413 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02584413, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.

TERMINATED
Registry status
NA
Development phase
29 participants
Enrollment target

Study Summary

Currently, optic pathway gliomas (OPG) are detected based on abnormal findings made during annual ophthalmologic exams. However, because these exams are annual, it is possible for healthcare providers to miss the point at which a child's vision begins to decline (potentially indicating an OPG). If at-risk children are screened for hypotonia early in life, those children who are hypotonic may undergo magnetic resonance imaging (MRI) to evaluate for OPG before they are showing ophthalmologic symptoms. This would enable healthcare providers to discover vision loss earlier and treat symptomatic OPGs earlier, thereby allowing us a better chance of preventing further vision loss in children with OPGs.

Primary Outcome

* A pediatric nurse practitioner (PNP) or a pediatric physician specializing in NF1, and physical therapist will screen the children for hypotonia. * The MRI scan will show hypotonia if the children have thickening or enlargement of any portion of the optic nerve, optic chiasm, or optic tracts. * The data analysis for this will be descriptive in nature.

Interventions

  • DEVICE Magnetic resonance imaging
  • DRUG Gadolinium contrast

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2013-04-16
Est. Completion 2019-02-07
Phase NA

Why NCT02584413 stopped before completion

NCT02584413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Magnetic resonance imaging is the first listed.

NCT02584413 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02584413 about?

NCT02584413 is a clinical study titled "Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma". Currently, optic pathway gliomas (OPG) are detected based on abnormal findings made during annual ophthalmologic exams. However, because these exams are annual, it is possible for healthcare providers to miss the point at which a child's vision begins to decline (potentially indicating an OPG). If a...

What is the current status of trial NCT02584413?

This trial is currently terminated. It is a NA study. The enrollment target is 29 participants. The study started on 2013-04-16. Estimated completion is 2019-02-07.

What interventions are being tested in trial NCT02584413?

The interventions under investigation include: Magnetic resonance imaging (DEVICE), Gadolinium contrast (DRUG).

Who is sponsoring clinical trial NCT02584413?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02584413's enrollment target sits among peer trials

29 1702nd of 2000 higher than 297 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT02584413, the US trial registry maintained by the National Library of Medicine. NCT02584413 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.