Hydroxyurea in Primary Progressive Multiple Sclerosis
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
- 否
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
干预措施: Hydroxyurea (Drug)
Placebo
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)
