BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
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.
The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as
 that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451).
 Subsequent to the initiation of this study, BG00012 was approved in several countries for the
 treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this
 study will receive the currently marketed dose of 240 mg BID.
Key Inclusion Criteria:

 -Subjects who participated in and completed as per protocol previous BG00012 clinical
 studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

 Key Exclusion Criteria:

 -  Any significant change in medical history from 109MS301 or 109MS302 that would have
 excluded subject's participation from their previous study.

 -  Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE
 or due to reasons other than protocol-defined relapse/disability progression.

 -  Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability
 progression or relapses and did not follow the modified visit schedule up to Week 96.

 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.