CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 30 target
Drug / intervention
Methylprednisolone +1 moredrug
Likely dose
Methylprednisolone 1000 mgfrom record
Key inclusion· 7
  • Multiple sclerosis diagnosed by 2017 Revised McDonald Criteria
  • Age 18 years or older
  • Able to provide informed consent
  • Can participate in study procedures with high-quality MRI data (limited prior artifacts)
Key exclusion· 8
  • MRI contraindications including non-MRI-compatible implants, pacemakers, infusion pumps, metallic implants or body piercings that cannot be removed
  • Psychological contraindications for MRI such as claustrophobia
  • Systemic steroid treatment in previous 30 days
  • New neurological symptoms with MS relapse onset in previous 2 weeks

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02784210
NCT02784210Phase 2RecruitingOn Track
Long Recruiting

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

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted May 27, 2016·Updated Jun 24, 2026

In Brief

A Phase 2 clinical trial evaluating Methylprednisolone and Prednisone for Multiple Sclerosis. Currently recruiting, targeting 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2Recruiting
2017201820192020202120222023202420252026202720282029
First PostedMay 27, 2016
Enrollment StartOct 5, 2016
Primary CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 12.2 yearsPosted 10.1 years agoPrimary completion in 2.5 years

Arms & Interventions

Methylprednisoloneexperimental

3 day course of intravenous methylprednisolone 1000 mg/day

Drug: Methylprednisolone
prednisoneexperimental

3-day course of oral prednisone 1250 mg/day

Drug: Prednisone

Interventions

Methylprednisolonedrug

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

Prednisonedrug

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