Clinical Trial Details
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NCT02410200 : Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
PhasePhase 2
AgesMin: 10 Years Max: 17 Years
Key Inclusion Criteria:

- Ability of parents or legal guardians to understand the purpose and risks of the
study and provide signed and dated informed consent and authorization to use
protected health information in accordance with national and local subject privacy
regulations. Subjects will provide assent in addition to the parent or legal
guardian, as appropriate, as per local regulations.

- Must have a body weight of ?30 kg at Screening and Day 1.

- Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) [Polman
2011] and International Pediatric Multiple Sclerosis Study Group criteria for
pediatric MS (2013) [Krupp 2013].

Key Exclusion Criteria:

- Primary progressive, secondary progressive, or progressive relapsing MS (as defined
by [Lublin and Reingold 1996]). These conditions require the presence of continuous
clinical disease worsening over a period of at least 3 months. Subjects with these
conditions may also have superimposed relapses but are distinguished from
relapsing-remitting subjects by the lack of clinically stable periods or clinical

- Disorders mimicking MS, such as other demyelinating disorders (e.g., acute
disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren
disease, lupus erythematosus, and neuromyelitis optica), 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.

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