A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Isokinetic muscle strength at the three most affected muscle groups.
研究概览
简要总结
The purpose of this study is to evaluate the effect of subcutaneous administration of immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy
NB. ONLY RECRUITING FROM DENMARK
详细描述
Introduction Intravenous immunoglobulin (IVIG) treatment is the only established treatment modality in Multifocal Motor Neuropathy (MMN). In order to maintain neuromuscular performance patients require lifelong treatment. Hospital-based treatments have high cost and inconveniences to patients, particularly in chronic disorders. Immunoglobulin preparations are now available for subcutaneous use as IgG replacement therapy. The safety and efficacy of subcutaneous infusion is reported to be comparable to i.v. preparations, and has been applied successfully in other autoimmune disorders. However patients with MMN have not previously been treated with subcutaneous immunoglobulin.
Hypothesis:
Subcutaneous immunoglobulin treatment is efficacious and safe with less patient inconvenience.
Primary endpoint:
Isokinetic muscle strength at the end of treatment A vs B (subcutaneous vs i.v.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings
排除标准
- •Other severe medical conditions
- •Pregnancy and lactation
- •Anti-coagulation therapy
研究组 & 干预措施
1
Subcutaneous Ig given twice a week.
干预措施: Subcutaneous immunoglobulin (Drug)
2
Intravenous Ig
干预措施: Intravenous immunoglobulin (Drug)
结局指标
主要结局
Isokinetic muscle strength at the three most affected muscle groups.
时间窗: At the end of each arm of the crossover study
次要结局
- Medical research council score (MRC-score),(At the end of each treatment arm of the crossover study)
- 9-hole peg test,(At the end of each treatment arm of the crossover study)
- 10m walking,(At the end of each treatment arm of the crossover study)
- Nerve conduction parameters,(At the end of each treatment arm of the crossover study)
- SF-36(At the end of each treatment arm of the crossover study)
- Adverse effects(During each treatment arm of the crossover study)