This clinical trial compares the relative efficacy of treating acute exacerbations of relapsing forms of Multiple Sclerosis with equivalent doses of oral and intravenous (IV) methylprednisolone. This is a randomized, blinded, multi-center study.
Intravenous methylprednisolone has been the standard of care for treating acute MS flares. However, the IV administration is cumbersome, inconvenient and expensive. A true comparison of these different approaches has not been undertaken in rigorous fashion. Prior studies have demonstrated the safety of such high doses of oral steroid. For this proposal we employ equivalent oral dosing (1400 mg/day) and compare that to 1000 mg/day IV therapy in patients seen within seven days of an acute exacerbation of MS. In addition, there are 2 arms to this double-blind, placebo controlled, randomized trial. One arm has an active IV and an oral placebo while the second arm has an IV placebo and an active oral dose. Therefore, each subject will receive an active treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
1400 mg qd/5 days
1000 mg/qd/5 days
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
The Jacobs Neurological Institute
Buffalo, New York, United States
Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
There is no data analysis for this study
Time frame: Day 28 and Day 90
Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.
Time frame: Day 28 and day 90
Frequency of Relapse Over Time (up to One Year) When Subjects With Relapsing Forms of MS Are Administered One Course of Oral Methylprednisolone Compared to IV Administration.
Time frame: Day 28 and day 90 and day 365
Improvement Using Targeted Neurological Deficits (TND).
Time frame: Day 28 and day 90
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University of Vermont, Burlington
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