A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety ofBG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis - IMAGINE

BIOGEN IDEC RESEARCH LIMITED0 个研究点目标入组 172 人开始时间: 2018年2月23日最近更新: 2018年3月12日

适应症

试验速览

暂无简介。

•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
•NOTE: Other protocol defined inclusion/exclusion criteria may apply.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.

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