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NCT01851434 · ClinicalTrials.gov registry record
Natural History of Optic Neuritis
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- 8
- Enrollment target
NCT01851434: Clinical Trial study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT01851434 is a clinical trial that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01851434 was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- 8 participants
- Enrollment target
Study Summary
Background: \- Optic neuritis often is a symptom of multiple sclerosis (MS). Many people who experience optic neuritis are later diagnosed with MS. MS disease activity seen on magnetic resonance imaging (MRI) scans is often greater than that seen in tests given during regular doctor's visits. Even though MRI is a helpful tool for studying optic neuritis and MS, more information is needed on how MS symptoms show up on MRI scans. Researchers want to use MRI scans to track changes in the optic nerve after an optic neuritis episode. This approach will help them study the relationship between optic neuritis and MS. Objectives: \- To collect more information about the relationship between optic neuritis and multiple sclerosis. Eligibility: * Individuals between 18 and 50 years of age who have new optic neuritis. * Individuals between 18 and 50 years of age who have new symptoms of MS other than optic neuritis. * Healthy volunteers between 18 and 50 years of age. Design: * Participants will be screened with a physical exam and medical history. They may provide blood or urine samples. * Participants with optic neuritis or other MS symptoms will have a baseline study visit. They will have a physical exam and full eye exam. To look for signs of MS, they will have evoked potential tests to see how the body responds to stimulation. They will also have an MRI scan to study any changes in the brain and optic nerves. * After the first visit, participants will have steroid treatment for 5 days for the optic neuritis. * Additional study visits will be given 1, 3, 6, 9, and 12 months after the baseline visit. The tests from the first visit, including the MRI scans, will be repeated at these visits. * Healthy volunteers will have a baseline study visit. They will have a physical exam and full eye exam. They will have evoked potential tests to see how the body responds to stimulation. They will also have an MRI scan to study any changes in the brain and optic nerves. * Healthy v
Primary Outcome
RNFL thickness in the affected eye 12 months after optic neuritis.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-03-20 |
| Est. Completion | 2017-10-26 |
Why NCT01851434 stopped before completion
NCT01851434 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01851434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01851434 about?
NCT01851434 is a clinical study titled "Natural History of Optic Neuritis". Background: \- Optic neuritis often is a symptom of multiple sclerosis (MS). Many people who experience optic neuritis are later diagnosed with MS. MS disease activity seen on magnetic resonance imaging (MRI) scans is often greater than that seen in tests given during regular doctor's visits. Even ...
What is the current status of trial NCT01851434?
This trial is currently terminated. The enrollment target is 8 participants. The study started on 2013-03-20. Estimated completion is 2017-10-26.
Who is sponsoring clinical trial NCT01851434?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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