Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Adverse Events up to Six Months Post-treatment
研究概览
简要总结
Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only and does not alter the course of disease.
Although the cause of MSA remains unclear, there is evidence of presence of common neuroinflammatory mechanisms in the MSA brains including activation of microglia and production of toxic cytokines. This research protocol is based on hypothesis that the MSA progression can be altered by blocking the neuroinflammatory activity.
This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains antibodies derived from human plasma which can block the inflammatory responses in the brain that can lead to loss of brain cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female older than 17 years.
- •Clinical diagnosis of probable multiple system atrophy
- •Provide written informed consent to participate in the study
- •Understand that they may withdraw their consent at any time
排除标准
- •Women who are pregnant or lactating
- •In the investigator's opinion, have any other significant systemic, hepatic, cardiac or renal illness.
- •In the investigator's opinion, the subjects are significantly dehydrated, as determined by clinical evaluation including measurement of skin turgor, blood urea nitrogen and creatinine values.
研究组 & 干预措施
1
Interventions included monthly infusions of intravenous immunoglobulin.
干预措施: intravenous immunoglobulin (IVIg) (Drug)
结局指标
主要结局
Number of Adverse Events up to Six Months Post-treatment
时间窗: Monthly, up to 8 months (including the screening visit and the final visit)
The primary outcome measure was to evaluate the safety and tolerability of the IVIG infusions in patients with multiple system atrophy. The primary endpoint was defined as the frequency of adverse events (AE). AEs including their severity and relationship to the IVIG were assessed throughout the study and at least 60 days after the last infusion. The AEs were considered to be related to the IVIG infusion (infusional AE) if they occurred during an infusion or within 72 hours afterwards. Non-infusional AEs were further classified as possible related to IVIG or likely not related to IVIG. Serious AEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization. Any AE was defined as occurrence of any symptom regardless of intensity grade.
次要结局
- Preliminary Efficacy of IVIg for Treatment of MSA.(Monthly, up to 8 months (including the screening visit and the final visit))
研究者
Peter Novak
Study Principle Investigator
University of Massachusetts, Worcester