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Kurzbeschreibung/Zielsetzung

Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of dimethyl fumarate in Subjects with Relapsing-Remitting Multiple Sclerosis

primary objective:
determine wether dimethyl fumarate when compared with placebo is reducing the proportion of relapsing subjects at 2 years

Additional Objectives:
-reducing the total number of newly enlarging T2 hyperintense lesions on brain MRI scans in a subset of patients at 2 years
-reducing the total number of Gd-enhancing lesions on brain MRI scans at 2 years in a siubset of patients
-reducing the rate of clinical relapses at 1 year
-slowing the progression of disability at 2 years as measured by at least 1.0 point increase on the EDSS from baseline EDSS >=1.0 hat sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 thast is sustained for 12 weeks