Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to assess the efficacy of oral BG00012 as compared with
 placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The
 secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and
 to compare the effect of BG00012 with placebo on additional clinical and radiological
 measures of disease activity.
Key Inclusion Criteria:

 -  Informed consent and assent as appropriate

 -  Must have a body weight of ≥30 kg

 -  Must have a diagnosis of RRMS as defined by the revised consensus definition for
 pediatric multiple sclerosis (MS)

 -  Must be ambulatory with a converted Krutzke Baseline Expanded Disability Status Scale
 (EDSS) score between 0 and 5.0, inclusive

 Key Exclusion Criteria:

 -  Primary progressive, secondary progressive, or progressive relapsing MS.

 -  History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute
 disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease
 and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious
 disorders.

 -  History of severe allergic or anaphylactic reactions, or known drug hypersensitivity
 to dimethyl fumarate (DMF) or fumaric acid esters.

 -  Prior treatment with any of the following medications within 12 months prior to
 randomization: mitoxantrone, cyclophosphamide, rituximab.

 -  Prior treatment with any of the following medications or procedures within 6 months
 prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine,
 azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (IV)
 immunoglobulin, plasmapheresis or cytapheresis.

 NOTE: Other protocol defined inclusion/exclusion criteria may apply.