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临床试验/NCT02117375
NCT02117375Unknown不适用

EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
115
试验地点
1
主要终点
Progressive neurological disability

研究概览

简要总结

The purpose of this study is to evaluate the prognostic value of early focal lesions and early diffuse lesions on ambulatory disability progression within 5 years after clinical onset.

详细描述

Prospective, multicentric study

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with multiple sclerosis:
  • Inclusion Criteria:
  • Relapsing Remitting Multiple Sclerosis patients (Mac Donald 2010 criteria)
  • First clinical event < 1 year
  • Brain MRI > 9 lesions or/and spinal cord attack with focal lesion on spinal cord MRI
  • Score Expended Disability Status Scale < 3
  • Age between 18 and 40 years

排除标准

  • Multiple Sclerosis progressive
  • Patients treated with immunosuppressive therapy
  • Pregnancy
  • Healthy volunteers:
  • Inclusion Criteria:
  • Age between 18 and 40 years
  • Exclusion Criteria:

结局指标

主要结局

Progressive neurological disability

时间窗: 5 years

Measurement by Expended Disability Status Scale

次要结局

  • Progressive ambulatory disability(5 years)
  • Progressive disability in the upper limbs(5 years)
  • Progressive urinary disability(5 years)
  • Progressive difficulty walking(5 years)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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