Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Completed
Biogen
Phase 3
2007-01-01
To determine if treatment with BG00012 can decrease the number of MS relapses during a
certain time period. To determine if, over time, BG00012 treatment can decrease the number of
certain types of brain lesions commonly seen in MS patients and slow down the time it takes
for the disease to get worse.
The purpose of this study is also to determine the safety of BG00012 and how well it is
tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used
to assess MS.
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Completed
Biogen
Phase 3
2007-06-01
To determine if treatment with BG00012 can decrease the number of MS relapses during a
certain time period. Other goals of the study are to determine if, over time, BG00012
treatment can decrease the number of certain types of brain lesions commonly seen in MS
patients and slow down the time it takes for MS to get worse.
Other objectives of the study are to determine the safety and tolerability of BG00012, as
well as the effect it may have on tests and evaluations used to assess MS. Additionally,
glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Completed
Biogen
Phase 3
2009-02-03
The primary objective of this study is to evaluate the long-term safety profile of BG00012
(dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term
efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further
the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic
resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301
(NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on
health economics assessments and the visual function test.
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