Effects of High-Dose Corticosteroids on MS Lesions in Animal or Cell Subjects
A Phase 2 interventional study is planned to evaluate the effects of a 3-day course of high-dose corticosteroids on MRI-detected MS lesions with a centripetal enhancement pattern. Participants will receive either intravenous methylprednisolone or oral prednisone, and outcomes will be followed up at weeks 13 and 25.
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Why it matters
Understanding how high-dose corticosteroids affect MS lesion characteristics may help in managing multiple sclerosis better, especially regarding imaging changes.
What this does not prove
No results or publication date are available, and planned endpoints are not findings. The subjects remain unspecified, creating uncertainty about the applicability of any potential results.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 30 · estimated
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (10)
study phasePHASE2
study designINTERVENTIONAL
sample size30
sample size basisestimated
interventionPatients 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.\n\nDesign:\n\nThis 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.
comparatorno treatment
primary endpointthe presence or absence of a hypointense phase rim around each lesion followed over time
follow upweek 13 and week 25
findings"detailedDescription": "Objectives:\n\nThe 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.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
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