A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Time to Disability Progression Independent of Relapse
研究概览
简要总结
The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by relapses.
- •Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization.
- •Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive.
- •Have a Multiple Sclerosis (MS) Severity Score of 4 or higher.
排除标准
- •Have a diagnosis of relapsing remitting multiple sclerosis or primary progressive MS as defined by the revised McDonald criteria.
- •Had a recent clinical relapse (within 3 months) prior to randomization.
- •Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Dimethyl fumarate
BG00012 120 mg (1 BG00012 120 mg capsule + 1 matching placebo capsule) orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID thereafter.
干预措施: dimethyl fumarate (Drug)
Dimethyl fumarate
BG00012 120 mg (1 BG00012 120 mg capsule + 1 matching placebo capsule) orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID thereafter.
干预措施: Placebo (Other)
Placebo
BG00012 120 mg capsule orally once a day supplemented with matching placebo capsules for the first 4 weeks of treatment, as an additional blinding measure. Matched placebo capsules only thereafter.
干预措施: dimethyl fumarate (Drug)
Placebo
BG00012 120 mg capsule orally once a day supplemented with matching placebo capsules for the first 4 weeks of treatment, as an additional blinding measure. Matched placebo capsules only thereafter.
干预措施: Placebo (Other)
结局指标
主要结局
Time to Disability Progression Independent of Relapse
时间窗: Up to 108 weeks
Time to onset of confirmed progression of disability is defined as 1 or more of the following criteria, confirmed at ≥ 6 months after start of treatment and at Week 108 using 1 or more of the following assessments: Expanded Disability Status Scale (EDSS) score increased from Baseline of ≥ 1 point if baseline EDSS ≤ 5.5, or ≥ 0.5 point if Baseline EDSS ≥ 6.0; Timed 25-Foot Walk (T25FW) ≥ 20% increase from Baseline in the time taken for the 25-foot walk; worsening on the 9-Hole Peg Test (9HPT; ≥ 20% increase from Baseline in the time taken for the 9HPT, confirmed in the same hand). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs.
次要结局
- Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)(Baseline, 2 years)
- Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)(Baseline, Week 108)
- Change From Baseline to Week 108 in ABILHAND Questionnaire Score(Baseline, Week 108)
- Percentage Change From Baseline to Week 108 in Whole Brain Volume(Baseline, Week 108)