30 Participants Needed

Corticosteroids for Multiple Sclerosis

JM
DS
SL
Overseen ByShari L Sawney
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Methylprednisolone is unique in treating multiple sclerosis because it can quickly reduce inflammation in the central nervous system during acute flare-ups by stabilizing the blood-brain barrier, which is not a feature of all MS treatments.12367

What data supports the effectiveness of the drug Methylprednisolone for treating multiple sclerosis?

A preliminary study suggests that Methylprednisolone (Medrol or Solu-Medrol) can help manage relapsing-remitting multiple sclerosis by reducing irritation in the central nervous system during acute flare-ups.12367

Who Is on the Research Team?

DS

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

I have been diagnosed with multiple sclerosis.
Ability to provide informed consent
Simultaneously participates in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry
See 4 more

Exclusion Criteria

Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed)
I have new symptoms from an MS flare-up in the last 2 weeks.
Pregnancy or current breastfeeding
See 5 more

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

1 visit

Treatment

Participants receive a 3-day course of high-dose corticosteroids, either intravenous methylprednisolone or oral prednisone

3 days

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

25 weeks
2 visits (in-person) at weeks 13 and 25

What Are the Treatments Tested in This Trial?

Interventions

  • Methylprednisolone
  • Prednisone
Trial Overview The trial is testing if a short-term high-dose corticosteroid treatment helps heal ring-enhancing lesions in MS patients better than no treatment. Participants will either receive three days of high-dose methylprednisolone intravenously or orally, along with stomach protection medication, followed by two follow-up visits for assessment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: prednisoneExperimental Treatment1 Intervention
3-day course of oral prednisone 1250 mg/day
Group II: MethylprednisoloneExperimental Treatment1 Intervention
3 day course of intravenous methylprednisolone 1000 mg/day

Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Medrol for:
  • Allergic reactions
  • Blood disorders
  • Cancer
  • Eye diseases
  • Immune system disorders
  • Inflammatory diseases
  • Respiratory diseases
  • Skin diseases
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Depo-Medrol for:
  • Allergic reactions
  • Blood disorders
  • Cancer
  • Eye diseases
  • Immune system disorders
  • Inflammatory diseases
  • Respiratory diseases
  • Skin diseases
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Solu-Medrol for:
  • 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

Trials
1,403
Recruited
655,000+

Published Research Related to This Trial

In a study of 901 patients with relapsing-remitting multiple sclerosis, methylprednisolone (MP) pulse therapy was administered with a mean frequency of 4 times, showing that the majority of patients received treatment multiple times, indicating its common use in managing acute exacerbations.
The study found that female patients were approximately 3.7 times more likely to seek MP pulse therapy compared to male patients, suggesting a gender difference in treatment-seeking behavior for MS management.
Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital.Tolou-Ghamari, Z., Shaygannejad, V., Ashtari, F.[2022]
Inadvertent injection of methylprednisolone acetate into the eye during vitrectomy can lead to severe retinal toxicity, resulting in significant vision loss and complications such as retinal necrosis and optic nerve damage.
This case highlights the critical need for careful identification of medications during eye surgeries to prevent serious adverse effects associated with incorrect injections.
Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy.Yonekawa, Y., Sun, G., D'Amico, DJ., et al.[2014]
In a study of 15 patients previously diagnosed with corticosteroid-induced arachnoiditis, only 3 exhibited the clinical symptoms of arachnoiditis, suggesting a low incidence of the condition among those affected.
The findings indicate that the severity of radiological changes did not correlate with the severity of symptoms, leading to the conclusion that methylprednisolone acetate (Depo-Medrol) should be avoided in procedures involving the thecal sac due to potential risks.
Depo-Medrol and myelographic arachnoiditis.Johnson, A., Ryan, MD., Roche, J.[2021]

Citations

Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. [2022]
Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]
Depo-Medrol and myelographic arachnoiditis. [2021]
Management of diskogenic pain using epidural and intrathecal steroids. [2019]
Management of optic neuritis in a developing African country. [2018]
Retinal and choroidal microvascular embolism after intranasal corticosteroid injection. [2022]
Survey of orthopaedic and sports medicine physicians regarding use of medrol dosepak for sports injuries. [2018]
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