Efficacy and Safety of BG00012 in MS

Exclusion Criteria

• •1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 \[Appendix 3\]).
• •2. History of malignancy.
• •3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• •4. History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease.
• •5. History of human immunodeficiency virus (HIV).
• •6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
• •7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
• •8. Body weight \>100 kg.
• •9. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
• •10. Any of the following abnormal blood tests at screening.
• •11. Any previous treatment with FUMADERM®, FAG-201, or BG00012.
• •12. A medication history that precludes entry into the study.
• •13. Female subjects who are currently pregnant or breast-feeding.