Multiple SclerosisPhase 2NCT02784210
Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques
A Phase 2 study testing Methylprednisolone and Prednisone in people with Multiple Sclerosis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Methylprednisolone and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2016to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Official title: The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study
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.
Read more
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.
Read the detailed description
Objectives:
The primary aim of this pilot study is to assess the effects of short-term, high-dose corticosteroid administration on the 12-week evolution of multiple sclerosis lesions with centripetal enhancement pattern on magnetic resonance imaging (MRI), in particular with respect to the development of a hypointense rim on 7-tesla phase images. In our prior work, the phase rim has been associated with persistent deleterious inflammation with poor repair and ongoing neurodegeneration within lesions.
Study population:
Up to 30 multiple sclerosis patients with asymptomatic contrast-enhancing lesions will be enrolled. Patients are randomly assigned to either 3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day or oral prednisone at 1250 mg/day) or to no treatment.
Design:
This is a single-site study.Patients undergo serial brain MRIs with gadolinium-based contrast agent on both 3- and 7-tesla scanners over an approximate 25-week period. 3-tesla scans are obtained at baseline and week 25. 7-tesla scans are obtained at baseline and at weeks 13 and 25. Participants with one or more centripetal/rim-enhancing lesions at the baseline scan are randomized and followed. Clinical evaluation and blood testing are performed at baseline and weeks 13 and 25.
Outcome measures:
The primary outcome measure is the presence or absence, on the week-13 7-tesla scan, of a hypointense phase rim in each of the lesions followed over time. Secondary outcome measures include the presence or absence of a hypointense phase rim at week 25, as well as the lesion volume and intralesional median R1 relaxation rate at weeks 13 and 25. From 3-tesla scans, we will measure the change in normalized intralesional proton density-weighted and T1-weighted signal, as well as the R1 relaxation rate, between baseline and week 25. We will also assess for the presence or absence of a hypointense phase at 3T. Additional exploratory outcome measures, including clinical and immunological assessments, will also be collected.
- Conditions
- Multiple Sclerosis
- Being tested
- Methylprednisolone, Prednisone
- Keywords
- Centripetal Enhancement, MRI, 7 Tesla, Gadolinium, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day
PrednisoneDrug
3 days of corticosteroids (oral prednisone at 1250 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | 3 day course of intravenous methylprednisolone 1000 mg/day Receives: Drug: Methylprednisolone |
| prednisone | Experimental | 3-day course of oral prednisone 1250 mg/day Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
From 3-tesla scans, we willmeasure the change in normalized intralesional proton density-weighted and T1-weighted signal, as wellas the R1 relaxation rate, between baseline and week 25.
Measured: week 25
The presence or absence of a 3T hypointense phase rim around each lesion
The presence or absence of a 3T hypointense phase rim around each lesion at week and 25
Measured: at week 25
The presence or absence of a hypointense phase rim around each lesion followed over time.
At week 25, the presence or absence of a hypointense phase rim around each lesion followed over time.
Measured: at week 25
Lesion volume and intralesional median R1 relaxation rate as determined from the 7T MP2RAGE scan,
Lesion volume and intralesional median R1 relaxation rate at weeks 13 and 25, as determined from the 7T MP2RAGE scan, comparing corticosteroid and no-treatment groups.
Measured: at week 13 and 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start5 Oct 2016
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel S Reich, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784210
- Sponsor's protocol ID
- 160114
- Other IDs
- 16-N-0114
- Status last verified
- 1 Oct 2026
- First submitted
- 26 May 2016
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that results in publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study
- ClinicalTrials.gov ID
- NCT02784210
- Acronym / sponsor ID
- 160114
- Conditions
- Multiple Sclerosis
- Keywords
- Centripetal Enhancement, MRI, 7 Tesla, Gadolinium, MS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
The primary aim of this pilot study is to assess the effects of short-term, high-dose corticosteroid administration on the 12-week evolution of multiple sclerosis lesions with centripetal enhancement pattern on magnetic resonance imaging (MRI), in particular with respect to the development of a hypointense rim on 7-tesla phase images. In our prior work, the phase rim has been associated with persistent deleterious inflammation with poor repair and ongoing neurodegeneration within lesions.
Study population:
Up to 30 multiple sclerosis patients with asymptomatic contrast-enhancing lesions will be enrolled. Patients are randomly assigned to either 3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day or oral prednisone at 1250 mg/day) or to no treatment.
Design:
This is a single-site study.Patients undergo serial brain MRIs with gadolinium-based contrast agent on both 3- and 7-tesla scanners over an approximate 25-week period. 3-tesla scans are obtained at baseline and week 25. 7-tesla scans are obtained at baseline and at weeks 13 and 25. Participants with one or more centripetal/rim-enhancing lesions at the baseline scan are randomized and followed. Clinical evaluation and blood testing are performed at baseline and weeks 13 and 25.
Outcome measures:
The primary outcome measure is the presence or absence, on the week-13 7-tesla scan, of a hypointense phase rim in each of the lesions followed over time. Secondary outcome measures include the presence or absence of a hypointense phase rim at week 25, as well as the lesion volume and intralesional median R1 relaxation rate at weeks 13 and 25. From 3-tesla scans, we will measure the change in normalized intralesional proton density-weighted and T1-weighted signal, as well as the R1 relaxation rate, between baseline and week 25. We will also assess for the presence or absence of a hypointense phase at 3T. Additional exploratory outcome measures, including clinical and immunological assessments, will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: Methylprednisolone3 day course of intravenous methylprednisolone 1000 mg/day |
| prednisone | Experimental | Drug: Prednisone3-day course of oral prednisone 1250 mg/day |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day | Drug | Methylprednisolone |
| Prednisone3 days of corticosteroids (oral prednisone at 1250 mg/day | Drug | prednisone |
Primary outcome
the presence or absence of a hypointense phase rim around each lesion followed over time
Time frame: at 13 weeks
At week 13, the presence or absence of a hypointense phase rim around each lesion followed over time.
4 secondary outcomes
The change in normalized intralesional proton density-weighted and T1-weighted signal, as well as the R1 relaxation rate, from 3T scan.
Time frame: week 25
The presence or absence of a 3T hypointense phase rim around each lesion
Time frame: at week 25
The presence or absence of a hypointense phase rim around each lesion followed over time.
Time frame: at week 25
Lesion volume and intralesional median R1 relaxation rate as determined from the 7T MP2RAGE scan,
Time frame: at week 13 and 25
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that results in publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel S Reich, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisolone and Prednisone in people with Multiple Sclerosis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel S Reich, M.D. ((301) 496-1801, reichds@ninds.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the presence or absence of a hypointense phase rim around each lesion followed over time (time frame: at 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.