Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
Status:
Recruiting
Trial end date:
2023-04-30
Target enrollment:
Participant gender:
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 25 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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)