Corticosteroids for Multiple Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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 protocolDesign:Participants will be screened under another protocolParticipants 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you cannot have taken systemic steroids in the past 30 days.
Is methylprednisolone safe for humans?
Methylprednisolone, a type of corticosteroid, has been associated with some safety concerns. It can cause serious side effects like retinal damage if accidentally injected into the eye and visual loss if injected inappropriately in the nose. However, it is commonly used to manage conditions like multiple sclerosis and sports injuries, indicating it is generally considered safe when used correctly.12345
How is the drug Methylprednisolone unique in treating multiple sclerosis?
What data supports the effectiveness of the drug Methylprednisolone for treating multiple sclerosis?
Who Is on the Research Team?
Daniel S Reich, M.D.
Principal Investigator
National Institute of Neurological Disorders and Stroke (NINDS)
Are You a Good Fit for This Trial?
Adults 25+ with Multiple Sclerosis (MS) who have a specific type of lesion on their brain MRI, are already part of another NINDS study, and can undergo MRI scans without issues. They shouldn't have used systemic steroids in the last month or be experiencing new MS symptoms. Pregnant or breastfeeding individuals and those with certain medical conditions like diabetes or gastric ulcers cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo baseline assessments including medical history, physical exam, blood and urine tests, neurological exams, and MRIs
Treatment
Participants receive a 3-day course of high-dose corticosteroids, either intravenous methylprednisolone or oral prednisone
Follow-up
Participants are monitored for safety and effectiveness with follow-up visits at week 13 and week 25, including clinical evaluations, blood tests, and MRIs
What Are the Treatments Tested in This Trial?
Interventions
- Methylprednisolone
- Prednisone
Methylprednisolone is already approved in United States, European Union, Canada for the following indications:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Neurological Disorders and Stroke (NINDS)
Lead Sponsor