跳至主要内容
临床试验/NCT01103583
NCT01103583终止2 期

Hydroxyurea in Primary Progressive Multiple Sclerosis

S. Andrea Hospital2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
33
试验地点
2
主要终点
the evaluation of safety and tolerability of hydroxyurea

研究概览

简要总结

The pathogenesis of MS remain elusive, however some studies have linked the disease with infection by Epstein-Barr virus; therefore the use of drugs with immunosuppressive or immunomodulating action alone may be less suitable for primary progressive MS.This study will evaluate treatment with hydroxyurea (HU) in primary progressive MS. Hydroxyurea act by inhibiting the synthesis of deoxynucleotides essential for viral transcription,HU has recently been used in combination with antiretroviral drugs in HIV and has been shown to limit immune activation and suppress viral load by both antiviral and cytostatic activities. Furthermore has been demonstrated experimentally that HU suppressed the expression of EBV. For these reasons HU could be useful in primary progressive MS with cytostatic and antiviral action , confirming the role of EBV in the pathogenesis of MS.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • sign written informed consent
  • 18 to 60 years of age inclusive
  • diagnosis of PP-MS according to McDonald criteria
  • EDSS score at screening of 2-7 inclusive

排除标准

  • hypersensitivity to hydroxyurea
  • patients who were treated with immunosuppressive drugs or steroid three month before
  • respiratory or urinary infections
  • history or presence of malignancy
  • pregnancy or lactation
  • low compliance to the therapy

研究组 & 干预措施

Hydroxyurea

Experimental

干预措施: Hydroxyurea (Drug)

Placebo

Placebo Comparator

干预措施: placebo (Other)

结局指标

主要结局

the evaluation of safety and tolerability of hydroxyurea

时间窗: two years

次要结局

  • the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis(two yeras)

研究者

发起方
S. Andrea Hospital
申办方类型
Other

研究点 (2)

Loading locations...

相似试验

Hydroxyurea in Primary Progressive Multiple Sclerosis | 临床试验