Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Pain after three months
研究概览
简要总结
Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness, fatigue and pain experienced by patients with post-polio syndrome. Intravenousimmunoglobulin (IvIg) reduces this inflammation. The purpose of this study is to investigate the clinical effect of IvIg in post-polio syndrome.
详细描述
Post-polio syndrome (PPS) is characterised by new muscle weakness, pain, and fatigue several years after the attack of acute polio. This leads to increased disability, and up to now only supportive therapy is available.
Patients with PPS lose more motor neurons than expected and surviving neurons fail to maintain neurogenic supply to enlarged motor units. New data report an increased level of inflammatory cytokines in the cerebrospinal fluid (CSF). Immune modulating therapy like IvIg could be an option and this pilot study is the first to investigate the clinical effect of IvIg in PPS. In addition, levels of cytokines in CSF and serum before and after treatment will be investigated.
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
- 0 Years 至 75 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Post-polio syndrome diagnosed at Dept of Neurology, Haukeland University Hospital Walking ability -
排除标准
- •Other autoimmune disorders Other ongoing autoimmune therapy Severe cardiopulmonary disease IgA deficiency Previous treatment of IvIg Wheelchair dependence
结局指标
主要结局
Pain after three months
Fatigue after 3 months
Muscle strength after 3 months
次要结局
- Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum