Project

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of dimethyl fumarate (BG00012) in Subjects with Relapsing-Remitting Multiple Sclerosis

Completed · 2008 until 2010

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2008
End Date
2010
Financing
Industry
Study Design
Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Phase III Study
Keywords
MS, dimethyl fumarate, phase III
Partner
Biogen Idec
Brief description/objective

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