NCT02644083终止不适用
Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Changes in phosphocreatine (PCr) in cerebral grey matter
研究概览
简要总结
The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS by 2010 McDonald criteria
- •Relapsing clinical course
- •Ages 18-55
- •Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)
排除标准
- •Systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease)
- •Treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline MRI scan.
- •Treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant
- •Prior treatment of greater than 1 month at any time with DMF
- •Inability to tolerate MRI procedures
- •Pregnant/breastfeeding
结局指标
主要结局
Changes in phosphocreatine (PCr) in cerebral grey matter
时间窗: baseline and 6 months of treatment with Dimethyl Fumarate (DMF)
PCr levels evaluated by magnetic resonance spectroscopy
次要结局
- Changes in ATP in normal appearing white matter (NAWM)(baseline and 6 months of treatment with Dimethyl Fumarate)
研究者
Rebecca Spain
Dr Rebecca Spain, MD, MSPH
Oregon Health and Science University
研究点 (1)
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