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New treatment option for Multiple Sclerosis
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?
Methylprednisolone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple sclerosis.
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
- 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.
- 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's taking place
- 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 - 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?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.