Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques

NCT02784210 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 16011416-N-0114
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. Sometimes they light up from the outer edge and fill inward. This is called ring enhancement. Researchers think this type of lesion may not heal as well as others. Corticosteroids are the standard treatment to reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose course of corticosteroids helps heal those lesions. Objective: To study the effects of short-term high-dose corticosteroids on ring-enhancing MS. Eligibility: Adults ages 18 and older who:

• Have MS and a rim-enhancing lesion on a prior brain MRI
• Are enrolled in another NINDS protocol Design: Participants will be screened under another protocol Participants will be randomly assigned to get either no treatment or 3 days of treatment with a corticosteroid. Participants will have:
• 1 baseline visit
• 3 days of high-dose steroids, intravenous or oral. If IV, participants will receive methylprednisolone by IV each day. Participants will also be prescribed medicine to protect their stomach.
• Follow-up visits will be at week 13 and week 25 after randomization to treatment or no treatment. Visits include medical history and physical exam. Participants will have blood and urine tests. Participants will also have neurological exams and MRIs. Participants lie on a table that slides into a cylinder. They are in the scanner 1.5-2 hours. They get a dye through a catheter: A needle guides a thin plastic tube into an arm vein.

Conditions

Multiple Sclerosis

Keywords

Centripetal Enhancement; MRI; 7 Tesla; Gadolinium; MS

Outcome Measures

Primary Outcomes (1)

• the presence or absence of a hypointense phase rim around each lesion followed over time

  At week 13, the presence or absence of a hypointense phase rim around each lesion followed over time.

  at 13 weeks

Secondary Outcomes (4)

• The change in normalized intralesional proton density-weighted and T1-weighted signal, as well as the R1 relaxation rate, from 3T scan.

  week 25

• The presence or absence of a 3T hypointense phase rim around each lesion

  at week 25

• The presence or absence of a hypointense phase rim around each lesion followed over time.

  at week 25

• Lesion volume and intralesional median R1 relaxation rate as determined from the 7T MP2RAGE scan,

  at week 13 and 25

Study Arms (2)

Methylprednisolone

EXPERIMENTAL

3 day course of intravenous methylprednisolone 1000 mg/day

Drug: Methylprednisolone

prednisone

EXPERIMENTAL

3-day course of oral prednisone 1250 mg/day

Drug: Prednisone

Interventions

Methylprednisolone DRUG

3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day

Methylprednisolone

Prednisone DRUG

3 days of corticosteroids (oral prednisone at 1250 mg/day

prednisone

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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)

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Methylprednisolone; Prednisone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Study Officials

• Daniel S Reich, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel S Reich, M.D.

CONTACT

(301) 496-1801; reichds@ninds.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: May 27, 2016
• Study Start: October 5, 2016
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after publication
• Access Criteria: Will be shared under tech transfer agreements

Locations

US (1)