NCT00217295Unknown2 期
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.
Multiple Sclerosis Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.
详细描述
The protocol requires all participants to be treated with Avonex and in addition patients will be blindly assigned to either a group who receive Topamax or a placebo control. Repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. The scaled neurologic examinations (EDSS and MSFC) and brain MRI's are done at regular intervals to evaluate possible treatment effects.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing-remitting multiple sclerosis
排除标准
- •Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -
结局指标
主要结局
Safety and tolerability
次要结局
- Brain atrophy on nMRI
- Disease progression on EDSS and MSFC
- Relapse rate
研究者
研究点 (2)
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