NCT02218879终止不适用
Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan
研究概览
简要总结
The primary objective is to directly estimate brain glutathione concentrations in vivo using H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS) patients considering switching therapy or being treatment-naive (first line).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult patients
- •18-60 years of age
- •Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
- •Patients naive to MS therapy or patients switching from an FDA-approved MS therapy, including IFN-B formulations, Cop-1, Teriflunomide, and Fingolimod to BG-12
- •Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
排除标准
- •Primary progressive multiple sclerosis patients
- •Patients with previous exposure or known allergies to fumarates
- •MS patients switching from natalizumab, cyclophosphamide, or mitoxantrone to BG-12
- •Contraindications for MRI/MRS
- •Known presence of other neurological disorders that may mimic multiple sclerosis
- •Pregnancy or lactation
- •Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- •History of or currently active primary or secondary immunodeficiency
- •Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis_
- •History of progressive multifocal leukoencephalopathy
- •Contraindications to or intolerance of oral or intravenous (IV) corticosteroids
研究组 & 干预措施
Patients with relapsing MS
干预措施: Tecfidera (Drug)
结局指标
主要结局
Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan
时间窗: Before and 12 months after Tecfidera Initiation
次要结局
未报告次要终点
研究者
研究点 (1)
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