A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis
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https://search.vivli.org/doiLanding/studies/00007193/isLanding
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资源简介:
This is a multicenter study conducted in 2 parts:
The primary objective in Part I of this study is to determine the efficacy of BG00012
(dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion
activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at
Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS)
including participants from the Asia-Pacific region.
The secondary objectives in Part I of this study in this study population are to determine
whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the
cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the
number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24
compared with Baseline.
The primary objective in Part II (open label) of this study is to evaluate the long-term
safety profile of BG00012 in eligible participants from Part I.
提供机构:
Vivli
创建时间:
2021-06-10



