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Corticosteroids for Multiple Sclerosis

Palo Alto (17 mi)

Overseen byIrene CM Cortese, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

No Placebo Group

Prior Safety Data

Trial Summary

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 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.

What safety data is available for corticosteroids used in MS treatment?Safety data for corticosteroids like Methylprednisolone (Medrol, Solu-Medrol) includes reports of adverse effects such as arachnoiditis, retinal necrosis, and vascular occlusion when used in certain conditions. A preliminary study on MS patients suggests its use in managing acute exacerbations, but detailed safety outcomes specific to MS treatment are not provided in the abstracts.² ³ ⁴ ⁶ ⁷

Is the drug Methylprednisolone, Prednisone a promising treatment for Multiple Sclerosis?Yes, Methylprednisolone (also known as Medrol or Solu-Medrol) is promising for treating Multiple Sclerosis. It helps manage relapsing-remitting MS by reducing irritation in the central nervous system and protecting the blood-brain barrier during acute flare-ups.¹ ² ⁵ ⁶ ⁷

What data supports the idea that Corticosteroids for Multiple Sclerosis is an effective treatment?The available research shows that methylprednisolone, a type of corticosteroid, can help manage relapsing-remitting multiple sclerosis by reducing irritation in the central nervous system. This suggests it can be effective during acute flare-ups of the condition. However, the other studies provided focus on different conditions, so they don't directly support its effectiveness for multiple sclerosis.¹ ² ⁵ ⁶ ⁷

Do I have to stop taking my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have taken systemic steroids in the previous 30 days before joining the trial.

Eligibility Criteria

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.

I am 25 years old or older.

Exclusion Criteria

I cannot take corticosteroids due to conditions like diabetes or stomach ulcers.

Treatment Details

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.

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:

🇺🇸 Approved in United States as Medrol for:

Allergic reactions
Blood disorders
Cancer
Eye diseases
Immune system disorders
Inflammatory diseases
Respiratory diseases
Skin diseases

🇪🇺 Approved in European Union as Depo-Medrol for:

Allergic reactions
Blood disorders
Cancer
Eye diseases
Immune system disorders
Inflammatory diseases
Respiratory diseases
Skin diseases

🇨🇦 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

Research locations nearbySelect from list below to view details:

National Institutes of Health Clinical CenterBethesda, MD

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Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor

References

1.United Statespubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. [2019]The use of methylprednisolone acetate (Depo-Medrol) injected by the epidural or intrathecal route for the relief of diskogenic back pain with or without radiculopathy is an adjunct to conservative management useful when conservative measures fail and surgical treatment is under consideration. This is especially true when symptoms have been present for only a few months. Corticosteroids injected in the same manner seem to have little effect on patients with symptoms persisting for periods longer than 3 months or in patients treated previously by surgical methods.

2.Australiapubmed.ncbi.nlm.nih.gov

Depo-Medrol and myelographic arachnoiditis. [2021]This study was undertaken to see if patients who had a radiological diagnosis of arachnoiditis attributed to methylprednisolone acetate (Depo-Medrol, Upjohn Pty Limited) had the clinical syndrome of arachnoiditis.

3.United Statespubmed.ncbi.nlm.nih.gov

Retinal and choroidal microvascular embolism after intranasal corticosteroid injection. [2022]Two patients had uniocular visual loss after methylprednisolone acetate (Depo-Medrol) injection for control of chronic inflammatory conditions in the nose. The cause of the visual loss was embolic retinal and choroidal vascular occlusion. The emboli were presumably aggregates of microcrystals of methylprednisolone acetate.

4.United Statespubmed.ncbi.nlm.nih.gov

Survey of orthopaedic and sports medicine physicians regarding use of medrol dosepak for sports injuries. [2018]To study the use of a methylprednisolone taper (Medrol Dosepak; Pfizer, New York, NY) short-term oral corticosteroid treatment modality by sports medicine physicians; included is discussion on indications, perceived efficacy, and complications.

5.Nigeriapubmed.ncbi.nlm.nih.gov

Management of optic neuritis in a developing African country. [2018]To show the value of sub-Tenon's depo-methylprednisolone acetate followed by oral prednisolone in the management of optic neuritis in African patients.

6.Iranpubmed.ncbi.nlm.nih.gov

Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. [2022]To manage relapsing-remitting multiple sclerosis (MS) in the course of acute exacerbations, methylprednisolone (MP) (Medrol or Solu-Medrol), has the ability to lock the injured blood-brain barrier and decrease irritation in the central nervous system. The aim of this preliminary study was to investigate the frequency and time interval related to MP pulse therapy in patients with MS.

7.United Statespubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]Methylprednisolone acetate (Depo-Medrol, Pfizer, New York) is a depot corticosteroid that is commonly injected periorbitally to treat various ophthalmologic conditions. Accidental intravitreal injections secondary to globe perforations have resulted in rapid retinal toxicity. To their knowledge, the authors report the first case of inadvertent intravitreal methylprednisolone acetate injection during pars plana vitrectomy.