Effects of corticosteroids on inflammation in multiple sclerosis lesions

The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study

This study is testing if high-dose corticosteroids can help heal certain lesions in people with multiple sclerosis by looking at changes in their MRI scans over 25 weeks.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Drugs / interventions: prednisone
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT02784210 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of short-term high-dose corticosteroids on the healing of ring-enhancing lesions in patients with multiple sclerosis. Participants aged 18 and older with specific MRI findings will be randomly assigned to receive either corticosteroids or no treatment. The study will utilize advanced MRI techniques, including 3- and 7-tesla scans, to monitor changes in lesions over a 25-week period. The primary outcome will assess the presence of a hypointense rim on MRI, indicating inflammation and healing status.

Who should consider this trial

Good fit: Ideal candidates are adults with multiple sclerosis who have a gadolinium-enhancing lesion showing centripetal or phase rim enhancement.

Not a fit: Patients with contraindications for MRI or those not enrolled in another NINDS protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment approach for managing asymptomatic multiple sclerosis lesions.

How similar studies have performed: While corticosteroids are standard for MS relapses, this specific approach to asymptomatic lesions is novel and has not been extensively tested in prior studies.

Eligibility criteria

* INCLUSION 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

EXCLUSION CRITERIA:

* 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 be removed);
* 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)

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel S Reich, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
• Study coordinator: Daniel S Reich, M.D.

Conditions: Multiple Sclerosis, Centripetal Enhancement, MRI, 7 Tesla, Gadolinium, MS