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Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse
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.
Age
18 - 59 years
Sex
ALL
Healthy Volunteers
No
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
Hospital de Figueres
Figueres, Girona, Spain
Hospital Dr. Trueta
Girona, Girona, Spain
Hospital Arnau de Vilanova
Lleida, Lleida, Spain
Start Date
November 1, 2008
Primary Completion Date
November 1, 2010
Completion Date
January 1, 2011
Last Updated
June 2, 2011
49
ACTUAL participants
methylprednisolone
DRUG
methylprednisolone
DRUG
Placebo
DRUG
Lead Sponsor
Germans Trias i Pujol Hospital
NCT06276634
NCT07225504
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06809192