Clareo Health | Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
10–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
