NCT01537575已完成3 期
Intravenous Immunoglobulins for Post-Polio Syndrome
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- SF-36 physical component
研究概览
简要总结
Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a history of acute poliomyelitis
- •increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis
- •a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi
排除标准
- •clinically relevant systemic disease
- •malignancy
- •hypothyroidism
- •diabetes mellitus not fully controlled by medical therapy
- •medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome
- •conditions associated with prolonged coagulation time
- •serum IgA deficiency
- •previous allergic reaction to IVIG
- •body-mass index greater than 30
- •immune-modulating treatments other than IVIG within the preceding 6 months
结局指标
主要结局
SF-36 physical component
时间窗: Baseline; 2 and 4 months after treatment
次要结局
未报告次要终点
研究者
Laura Bertolasi
Head of the Neurophysiology Unit
Azienda Ospedaliera Universitaria Integrata Verona
相似试验
已完成
不适用
Characterization of the Immunological Profile Patients With Post-polio SyndromePoliomyelitis SequelaeNCT03396783University Hospital, Montpellier73
已完成
2 期
Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)Post-Polio SyndromeNCT00231439Haukeland University Hospital40
已完成
不适用
Treatment of Post-poliomyelitis Syndrome by Intravenous ImmunoglobulinPost-Poliomyélitis SyndromNCT04004390University Hospital, Montpellier17
Unknown
3 期
Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans NewbornsPoliomyelitisNCT01870206Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.320
已完成
2 期
Coenzyme Q10 for Alleviation of the Fatigue of Post Polio SyndromeExcessive fatigue symptom of Post Polio Syndrome/Late Effects of PolioNeurological - Other neurological disordersACTRN12612000552886Professor Marie Cooke110