A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Biogen
- 主要终点
- Time to first multiple sclerosis (MS) relapse
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
BG00012
Participants will receive 120 mg capsule(s) BG00012 taken orally.
干预措施: dimethyl fumarate (Drug)
Placebo
Participants will receive matching placebo capsule(s) taken orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first multiple sclerosis (MS) relapse
时间窗: Up to week 104
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
次要结局
- Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)(Up to week 104)
- Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans(Weeks 24, 48, 72 and 96)
- Number of gadolinium-enhancing Lesions(Baseline, and weeks 24, 48, 72 and 96)
- Annualized MS relapse rate(weeks 48 and 96)