Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- number of new T2 lesions on brain MRI performed after 18 months of Sunphenon treatment compared to baseline MRI in the verum arm versus placebo
研究概览
简要总结
Hypothesis:
Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a period of 18 months has anti-inflammatory and neuroprotective properties in patients with relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical examination (EDSS and MSFC).
详细描述
This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •male and female subjects age 18 to 60
- •relapsing-remitting course of MS
- •stable treatment with glatiramer acetate at least 6 months prior to inclusion
排除标准
- •primary or secondary progressive forms of MS
- •clinically relevant heart, lung, liver, kidney diseases
- •regular hepatotoxic co-medication
- •drug addiction
- •alcohol abuse
研究组 & 干预措施
verum
Sunphenon plus glatiramer acetate
干预措施: epigallocatechin-gallate (Sunphenon) (Drug)
placebo
placebo plus glatiramer acetate
干预措施: placebo (Drug)
结局指标
主要结局
number of new T2 lesions on brain MRI performed after 18 months of Sunphenon treatment compared to baseline MRI in the verum arm versus placebo
时间窗: 18 months
次要结局
- Safety and tolerability(18 months)
- development of brain atrophy under treatment with EGCG vs. placebo(18 months)
研究者
Friedemann Paul
Prof.
Charite University, Berlin, Germany