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

Who is this study for? Patients with Multiple Sclerosis
What treatments are being studied? Methylprednisolone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Shari L Sawney
shari.sawney@nih.gov
(301) 496-3825
Backup
Daniel S Reich, M.D.
reichds@ninds.nih.gov
(301) 496-1801
Time Frame
Start Date: 2016-10-05
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Methylprednisolone
3 day course of intravenous methylprednisolone 1000 mg/day
Experimental: prednisone
3-day course of oral prednisone 1250 mg/day
Authors
Irene CM Cortese
Related Therapeutic Areas
Sponsors
Leads: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov