Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The contrast sensibility of the eye after 3 months of the treatment
研究概览
简要总结
The purpose of this study is to investigate if the simvastatin treatment improve the visual function after 3 months of the inclusion to this project and if the simvastatin influences the results on cerebral MRI after 3 and 6 months of the inclusion. In addition the development of new demyelinating relapses. In the patients with monosymptomatic acut optic neuritis to investigate whether the simvastatin reduces the risk to develop multiple sclerosis (MS).
详细描述
Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease in the Central Nervous System (CNS). Acute optic neuritis is a common symptom of MS and is considered to have the same pathogenesis as MS, where autoimmune and inflammatory mechanisms lead to the progression of MS.
Statins reduce the cholesterol in blood and in addition have anti-inflammatory effects. From experimental data and results from pilot projects there is evidence that the statins perform anti-inflammatory and immune-modulatory effects and one can expect a beneficial outcome in the autoimmune inflammatory diseases after the treatment with statins.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Optic Neuritis
- •Abnormal contrast sensitivity score (>80)
- •Symptom duration maximum 4 weeks
- •Men and women between 18 and 59 years old
- •The patient must be physical and mental able to participate i this project with a 6 months of the duration
- •The patient must sign the written consent of the participation before the inclusion.
排除标准
- •Optic neuritis earlier in the same eye
- •Pregnancy
- •Fertile women who do not use contraception
- •Women who contemplate pregnancy in the duration of the study
- •Steroid treatment the last 4 weeks before the inclusion
- •Immune-supressor treatment the last 6 months before the inclusion
- •Active liver disease or continuous increase of liver enzymes (ASAT, ALAT)without known reason.
- •Kidney failure
- •Hyperthyroidism
- •Diabetes mellitus
- •Alcoholism
- •Fibrates intake
- •Statin treatment for other disease
- •Simultaneous participation in other studies.
研究组 & 干预措施
B
simvastatin tablets 80 mg daily
干预措施: simvastatin (Drug)
A
calcium tablets 80 mg
干预措施: placebo (Drug)
结局指标
主要结局
The contrast sensibility of the eye after 3 months of the treatment
时间窗: 6 months
次要结局
- Visual acuity(6 months)
- visual evokes potentials (VEP)(6 months)
- cerebral MRI(6 months)
- Developing MS after 6 months(6 months)