This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate or severe attack receiving immunomodulatory therapy or not. Patients will be randomly assigned to one of the two groups.
This is a multicenter, randomized, double blind clinical trial to test whether oral methylprednisolone (MP) is not inferior to intravenous methylprednisolone for the treatment of multiple sclerosis (MS) relapse in terms of clinical and radiological efficacy. Patients will be randomly assigned to one of the following two groups. Group A: methylprednisolone 1.000 mg/day intravenous administered during three days + placebo of methylprednisolone orally administered Group B: methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenously administered. Clinical visits will be conducted at 7, 28 and 90 days after treatment starting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
methylprednisolone 1.000 mg/day intravenous administration during three days
methylprednisolone 1.250 mg/day orally administered during three days
Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Hospital de Mataró
Barcelona, Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis
Time frame: day 28
Change in EDSS in patients who present a relapse from different type or unknown topography
Time frame: day 28
Change in the punctuation in each group
Time frame: between days 7 and 0
Percentage of patients who improve, get worse and keep stable
Time frame: days 7 and 28
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Hospital de Figueres
Figueres, Girona, Spain
Hospital Dr. Trueta
Girona, Girona, Spain
Hospital Arnau de Vilanova
Lleida, Lleida, Spain