CTIS2022-501717-31-00进行中(未招募)1 期
Effect of intravenous immunoglobulins on painful sensory neuropathy evaluated by aggregated N-of-one trials
Sorlandet Sykehus HF0 个研究点目标入组 30 人开始时间: 2022年8月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 64(—)
- 性别
- All
入选标准
- •18-65 years, Painful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or idiopathic sensory neuronopathy, Pain intensity at least 5.0 on Numeric Rating Scale (NRS) lasting at least 4 weeks, Signed written informed consent
排除标准
- •Change of pain medication in the 30 days prior to inclusion, Treatment with IVIG or other immunomodulatory agents the last 4 weeks, Contraindications to IVIG ie previous stroke, myocardial infarction, or other thrombotic events, hypertension (uncorrected), smoking, diabetes, prolonged immobilization, hypercoagulable state, IgA deficiency, renal failure, ongoing heart disease, hypovolemia, previous allergic reactions to IVIG, Females who are breastfeeding, pregnant, or unwilling to practice adequate contraception throughout the study
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