Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- brain atrophy
研究概览
简要总结
The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG) treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more effective than an oral placebo treatment regarding following parameters: increase in brain atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in patients with MS.
详细描述
The hypotheses of our study are:
Sunphenon EGCg has an antiinflammatoric effect due to its impact on the T-cell-proliferation and the inhibition of the activity of NF-Kb.
Sunphenon EGCg has a neuroprotective effect due to its antioxidative potence as a radical scavenger.
A 30 month treatment with Sunphenon EGCg is safe and well-tolerated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary chronic progressive multiple sclerosis (ms)
- •Age 18-65
排除标准
- •Relapsing-remitting ms
- •Immunodulatoric or immunosuppressive therapy
- •pretreatment with Mitoxantron, Natalizumab, Rituximab, Azathioprin <2 month before screening
- •pretreatment with Glairameracetat or beta-Interferons <4 weeks before screening
- •signs of hepatic dysfunction
- •active ulcus ventriculi or duodeni
- •neoplasias if not cured >1 year before screening
研究组 & 干预措施
Sunphenon
干预措施: Sunphenon EGCG (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
brain atrophy
时间窗: 36 months of treatment
次要结局
- number of AEs(36 months of treatment)
- reduction of the NAA/Cr-ratio in MR-spectroscopy(36 months of treatment)
- new T2 lesions(36 months of treatment)
- progression of disability such as cognitive disorders(36 months of treatment)
研究者
Friedemann Paul
Prof. Dr.
Charite University, Berlin, Germany