RecruitingPhase 2NCT02784210

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

The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study


Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Enrollment

30 participants

Start Date

Oct 5, 2016

Study Type

INTERVENTIONAL

Conditions

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. ...


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is using specialized high-powered MRI brain scans to examine what happens at the edges of active multiple sclerosis (MS) lesions — areas of nerve damage in the brain — before and after treatment with corticosteroids (anti-inflammatory drugs), to better understand this type of MS inflammation. **You may be eligible if...** - You have been diagnosed with multiple sclerosis - You are 18 years or older - Your brain MRI shows a specific active lesion with a ring or rim pattern of inflammation (called rim or centripetal enhancement) - You are also participating in another MS research or natural history protocol at the NINDS clinic - You are willing to use contraception if you could become pregnant **You may NOT be eligible if...** - You have metal implants, a pacemaker, or other conditions making MRI unsafe - You have medical reasons why you cannot take corticosteroids - You are pregnant or breastfeeding - You cannot complete the required MRI procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethylprednisolone

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

DRUGPrednisone

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


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT02784210


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