Multiple Sclerosis study: Methylprednisolone vs Prednisone
Official title Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
ClinicalTrials.gov ID: NCT02784210
What this study is testing
What is Methylprednisolone?
This is an investigational high-dose corticosteroid being studied to see if it helps heal specific types of brain lesions in people with multiple sclerosis. It is designed to reduce inflammation in the body.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if a short course of high-dose steroids helps heal a specific type of brain lesion that may not heal well on its own.
- Who it's for
- Adults aged 18 and older who have multiple sclerosis and a specific type of lesion on a previous brain scan.
- What's involved
- Participants will be randomly assigned to receive either no treatment or 3 days of high-dose steroids (given by IV or by mouth). They will also have blood and urine tests, physical exams, and brain scans.
- Time commitment
- The study lasts about 25 weeks, requiring a baseline visit, 3 days of treatment, and follow-up visits at week 13 and week 25.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Multiple sclerosis, as defined by the 2017 Revised McDonald Criteria;
- Age 18 or older;
- Ability to provide informed consent;
- Able to participate in study procedures and provide high-quality clinical research and imaging data, based on limited artifacts on prior MRI scans...
- Presence of a gadolinium enhancing lesion on the screening (3T or 7T) brain MRI that demonstrates either centripetal/rim enhancement or a phase rim...
You likely can't join if
- Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic...
- Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected;
- Treatment with systemic steroids in previous 30 days (non-systemic administration of steroids, such as topical or local injection, is acceptable);
- Experiencing new neurological symptoms, with onset in previous 2 weeks, attributable to MS relapse;
- Pregnancy or current breastfeeding;
- Screening labs, only if required per current NIH Clinical Center guidelines for kidney-function screening before gadolinium-based MRI contrast...
See the full eligibility criteria
- Multiple sclerosis, as defined by the 2017 Revised McDonald Criteria;
- Age 18 or older;
- Ability to provide informed consent;
- Able to participate in study procedures and provide high-quality clinical research and imaging data, based on limited artifacts on prior MRI scans and, when possible to determine;
- Presence of a gadolinium enhancing lesion on the screening (3T or 7T) brain MRI that demonstrates either centripetal/rim enhancement or a phase rim, or both;
- Simultaneously participates in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.
- Willing to use birth control if able to conceive a child
- 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...
- Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected;
- Treatment with systemic steroids in previous 30 days (non-systemic administration of steroids, such as topical or local injection, is acceptable);
- Experiencing new neurological symptoms, with onset in previous 2 weeks, attributable to MS relapse;
- Pregnancy or current breastfeeding;
- Screening labs, only if required per current NIH Clinical Center guidelines for kidney-function screening before gadolinium-based MRI contrast, demonstrating estimated glomerular filtration rate \<60 mL/min;
- Known hypersensitivity to gadolinium-based contrast agents;
- Medical contraindications to corticosteroid administration (e.g., diabetes, gastric ulcer)
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.