Could steroids fix stubborn MS lesions? new trial investigates
NCT ID NCT02784210
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 8 times
Summary
This phase 2 trial tests whether a 3-day course of high-dose corticosteroids (methylprednisolone or prednisone) can help heal ring-enhancing brain lesions in people with multiple sclerosis. Thirty adults with MS and a specific type of active lesion will be randomly assigned to receive either steroids or no treatment. Researchers will use MRI scans at 13 and 25 weeks to see if the lesions shrink or change. The goal is to find a better way to manage these hard-to-heal lesions, even when there are no obvious relapse symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- corticosteroids (methylprednisolone or prednisone)
- What this could lead to
- If it works, this could show that a short course of high-dose steroids helps heal certain MS brain lesions, potentially improving recovery without long-term medication.
- What could go wrong
- This is a small early-phase trial with only 30 people, so results may not apply to everyone. Corticosteroids have side effects like stomach irritation and mood changes, and the treatment may not improve lesion healing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2016
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Multiple sclerosis, as defined by the 2017 Revised McDonald Criteria; * Age 18 or older; * Ability to provide informed consent; * Able to participate in study procedures and provide high-quality clinical research and imaging data, based on limited artifacts on prior MRI scans and, when possible to determine; * Presence of a gadolinium enhancing lesion on the screening (3T or 7T) brain MRI that demonstrates either centripetal/rim enhancement or a phase rim, or both; * Simultaneously participates in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry. * Willing to use birth control if able to conceive a child EXCLUSION CRITERIA: * Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed); * Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected; * Treatment with systemic steroids in previous 30 days (non-systemic administration of steroids, such as topical or local injection, is acceptable); * Experiencing new neurological symptoms, with onset in previous 2 weeks, attributable to MS relapse; * Pregnancy or current breastfeeding; * Screening labs, only if required per current NIH Clinical Center guidelines for kidney-function screening before gadolinium-based MRI contrast, demonstrating estimated glomerular filtration rate \<60 mL/min; * Known hypersensitivity to gadolinium-based contrast agents; * Medical contraindications to corticosteroid administration (e.g., diabetes, gastric ulcer)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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