BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl
 fumarate) compared with placebo slows the accumulation of disability not related to relapses
 in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective
 of the study is to assess the effect of BG00012 compared with placebo on patient-reported
 outcomes, brain atrophy, and cognitive function.
Key Inclusion Criteria:

 -  Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as
 relapsing-remitting disease followed by progression of disability independent of or
 not explained by relapses.

 -  Have documented confirmed evidence of disease progression independent of clinical
 relapses over the 1 year prior to randomization.

 -  Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive.

 -  Have a Multiple Sclerosis (MS) Severity Score of 4 or higher.

 Key Exclusion Criteria:

 -  Have a diagnosis of relapsing remitting multiple sclerosis or primary progressive MS
 as defined by the revised McDonald criteria.

 -  Had a recent clinical relapse (within 3 months) prior to randomization.

 -  Uncontrolled intercurrent illness including, but not limited to: ongoing or active
 infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac
 arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled
 diabetes; serious or acute psychiatric illness that would limit compliance with study
 requirements.

 Note: Other protocol-defined Inclusion/Exclusion criteria may apply