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Corticosteroid

Corticosteroids for Multiple Sclerosis

Phase 2
Recruiting
Led By Irene CM Cortese, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of multiple sclerosis as defined by the 2017 Revised McDonald Criteria
Age 25 or older
Must not have
Medical contraindications to corticosteroid administration (e.g., diabetes, gastric ulcer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 13 and 25
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the effects of short-term high-dose corticosteroids on ring-enhancing MS.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Corticosteroids like Methylprednisolone may cause side effects including mood swings, increased blood sugar levels, stomach irritation, insomnia, and an elevated risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with multiple sclerosis.
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I am 25 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take corticosteroids due to conditions like diabetes or stomach ulcers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 13 and 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 13 and 25 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
the presence or absence of a hypointense phase rim around each lesion followed over time
Secondary study objectives
Lesion volume and intralesional median R1 relaxation rate as determined from the 7T MP2RAGE scan
The change in normalized intralesional proton density-weighted and T1-weighted signal, as well as the R1 relaxation rate, from 3T scan.
The presence or absence of a 3T hypointense phase rim around each lesion
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
2015
Completed Phase 4
~2280
Prednisone
2014
Completed Phase 4
~2500

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,377 Previous Clinical Trials
651,786 Total Patients Enrolled
37 Trials studying Multiple Sclerosis
9,730 Patients Enrolled for Multiple Sclerosis
Irene CM Cortese, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
5 Previous Clinical Trials
781 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
9 Patients Enrolled for Multiple Sclerosis
Daniel S Reich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
10 Previous Clinical Trials
4,303 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
4,303 Patients Enrolled for Multiple Sclerosis

Media Library

Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02784210 — Phase 2
Multiple Sclerosis Research Study Groups: Methylprednisolone, prednisone
Multiple Sclerosis Clinical Trial 2023: Methylprednisolone Highlights & Side Effects. Trial Name: NCT02784210 — Phase 2
Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02784210 — Phase 2
~10 spots leftby Dec 2028
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