Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Proportion of patients with worsening in cognitive improvement over 2 years.
研究概览
简要总结
The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005).
- •Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- •Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of gadolinium-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:
- •Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
- •Severe depression (MADRS score >34) (Montgomery and Asberg 1979)
- •History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
- •An MS relapse that has occurred within the 30 days prior to inclusion AND/OR the participant has not stabilized from a previous relapse prior to inclusion.
研究组 & 干预措施
BG00012
BG00012 administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter.
干预措施: dimethyl fumarate (Drug)
结局指标
主要结局
Proportion of patients with worsening in cognitive improvement over 2 years.
时间窗: Up to 2 years
As measured by at least 2 standard deviation (SD) below Italian normative data of the Rao's Brief Repeatable Battery of Neuropsychological Tests (BRB) and a 100-item version of the Stroop Test. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) is a sensitive measure of cognitive impairment in multiple sclerosis (MS) patients. The Stroop Test is a test used to measure a person's sustained attention for word reading and color naming with and without interference.
次要结局
- Change in cognitive impairment index score (CII) over two years(Up to 2 years)
- Annualized relapse rate at year 1.(Up to one year)
- Annualized relapse rate at year 2.(Up to 2 years)
- Time to relapse over 2 years.(2 years)
- Proportion of patients with 6-month sustained progression of disability as measured by at least a 1.0 point increase from a baseline EDSS>1.0 or at least a 1.5 point increase from a baseline EDSS=0).(Up to 2 years)
- Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.(Up to 2 years)
- Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS)(2 years)
- Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)(2 years)
- Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey(2 years)
- Change from baseline in the Environmental Status Scale (ESS)(2 years)