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Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques

NCT02784210 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

Multiple sclerosis (MS) affects the brain, spinal cord, and optic nerves. MS lesions can appear on the MRI (magnetic resonance imaging) scans in many ways. Sometimes they light up from the outer edge and fill inward. This is called ring enhancement. Researchers think this type of lesion may not heal as well as others. Corticosteroids are the standard treatment to reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose course of corticosteroids helps heal those lesions.

Objective:

To study the effects of short-term high-dose corticosteroids on ring-enhancing MS.

Eligibility:

Adults ages 18 and older who:

* Have MS and a rim-enhancing lesion on a prior brain MRI
* Are enrolled in another NINDS protocol

Design:

Participants will be screened under another protocol

Participants will be randomly assigned to get either no treatment or 3 days of treatment with a corticosteroid.

Participants will have:

* 1 baseline visit
* 3 days of high-dose steroids, intravenous or oral. If IV, participants will receive methylprednisolone by IV each day. Participants will also be prescribed medicine to protect their stomach.
* Follow-up visits will be at week 13 and week 25 after randomization to treatment or no treatment.

Visits include medical history and physical exam. Participants will have blood and urine tests. Participants will also have neurological exams and MRIs. Participants lie on a table that slides into a cylinder. They are in the scanner 1.5-2 hours. They get a dye through a catheter: A needle guides a thin plastic tube into an arm vein.

Conditions

Interventions

DRUG

Methylprednisolone

3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day

DRUG

Prednisone

3 days of corticosteroids (oral prednisone at 1250 mg/day

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Daniel S Reich, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-05
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02784210 on ClinicalTrials.gov