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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 13 and 25
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with multiple sclerosis.
Select...
I am 25 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 13 and 25
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 13 and 25
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
the presence or absence of a hypointense phase rim around each lesion followed over time
Secondary outcome measures
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 moreTrial 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
~2370
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,340 Previous Clinical Trials
649,329 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
9,279 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
4,302 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
4,302 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with multiple sclerosis.I have new symptoms from an MS flare-up in the last 2 weeks.My kidney function test shows less than 60 mL/min.I cannot take corticosteroids due to conditions like diabetes or stomach ulcers.I am 25 years old or older.I can follow study procedures and my previous MRI scans are clear.I haven't taken steroid pills or injections into my veins or muscles in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Methylprednisolone
- Group 2: prednisone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still enrolling volunteers for this research project?
"This study is actively recruiting participants, according to the latest information on clinicaltrials.gov. The trial was first posted on October 5, 2016 and last updated on November 16, 2022."
Answered by AI
Has Methylprednisolone been given the green light by the FDA?
"Methylprednisolone has some clinical data supporting its safety, but none yet for efficacy. Our team rated it a 2."
Answered by AI
Are there previous instances of research on Methylprednisolone?
"There are a total of 415 active clinical trials related to Methylprednisolone. 115 of those studies have progressed to phase 3 testing. The majority of these investigations are based out of Duarte, California; however, there are 17112 locations running methylprednisolone trials globally."
Answered by AI
How many people are signing up to participate in this trial?
"That is correct. According to the most recent information on clinicaltrials.gov, this trial is still looking for 30 individuals to participate at a single site."
Answered by AI
What conditions does Methylprednisolone usually alleviate?
"Methylprednisolone is a medication used to help with scalp structure. Additionally, it can be taken to alleviate symptoms from thyroiditis, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."
Answered by AI
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