Lead Sponsor

Biogen

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

No

•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

•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.