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临床试验/NCT00200655
NCT00200655已完成3 期

Safety and Efficacy of Pravastatin in Relapsing-remitting MS: a Double Blind Placebo Controlled Study

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年12月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Number of gadolinium positive lesions at month 6 in each group.

研究概览

简要总结

Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called "statins"). In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was associated with a decreased lesional activity assessed by MRI. Statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in MS. The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting 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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Relapsing remitting MS with diagnosis defined by the McDonald criteria (McDonald et al., 2001) with no current disease modifying therapy (interferon, copaxone or immunosuppressant drugs) since at least 3 months and an EDSS score <
  • At least one gadolinium positive lesion on the MRI of the selection phase is needed.
  • No current statin therapy.
  • Normal renal and hepatic biological tests.
  • No current pregnancy

排除标准

  • 未提供

结局指标

主要结局

Number of gadolinium positive lesions at month 6 in each group.

时间窗: at month 6 in each group

次要结局

  • Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up(after 6 months of follow-up)
  • Number of new T2 lesions

研究者

申办方类型
Other

研究点 (2)

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