Clinical Trial Details
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NCT02430532 : BG00012 and Disability Progression in Secondary Progressive Multiple Sclerosis (SPMS)
PhasePhase 3
AgesMin: 18 Years Max: 58 Years
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 EDSS score of 3.0 to 6.5, inclusive.

- Have an multiple sclerosis (MS) Severity Score of 4 or higher.

Key Exclusion Criteria:

- Have a diagnosis of relapsing remitting multiple sclerosis (RRMS) 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

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