NL-OMON47574已完成3 期
Intravenous immunoglobulin therapy for small fiber neuropathy: a randomized, double-blind, placebo-controlled study on efficacy and safety. - IVIg in SF
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 18 years or older.
- •* Skin-biopsy proven idiopathic SFN or idiopathic painful neuropathy with predominantly SFN pattern
- •* Pain intensity rated * 5 on the PI-NRS (maximum pain) or on the neuropathic pain scale question number 1 for at least 12 weeks before the study as declared by each patient to the best of their knowledge; if available, medical records of each patient will be consulted on the reported pain intensity.
- •* Each subject will receive an information leaflet and an informed consent form. Subjects must give informed consent by signing and dating prior to study entry.
- •* Eligible patients must be willing to complete all study-related activities and examination required by the protocol.
排除标准
- •Patients will be excluded if they:
- •* Are unable or unwilling to provide written informed consent.
- •* Have predominant clinical picture of large nerve fiber involvement (i.e., weakness, loss of vibration sense, hypo-/areflexia).
- •* Had treatment with IVIg or any other immunomodulatory/immunosuppressive agents (e.g., steroids) within the last 12 weeks prior to the date of informed consent.
- •* Have an underlying cause of SFN (diabetes, SCN9A/10A/11A mutations, hypothyroidism, renal failure, vitamin B12 deficiency, monoclonal gammopathy, alcohol abuse (more than 5 IU/day), malignancies, drugs that cause neuropathy (e.g. chemotherapy, amiodarone, propafenone)).
- •* Have a history of anaphylaxis or severe systemic response to immunoglobulin or with a blood product.
- •* Have cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, or history of congestive heart failure, severe hypertension (diastolic blood pressure >120 mmHg or systolic >170 mmHg).
- •* Are females who are pregnant, breast-feeding, or if of childbearing potential, or unwilling to practice adequate contraception throughout the study.
- •* Have known hyperviscosity.
- •* Have a history of renal insufficiency or high serum creatinine levels .
- •* Have known selective IgA deficiency.
- •* Have conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
- •* Have a known hypercoagulable state.
- •* Are mentally challenged adult subjects unable to give independent informed consent.
- •* The use of pain (analgesic/anti-neuropathic) medication is allowed, but only if dosages are remained unchanged for at least 30 days prior to randomization. A change in dosage of these drugs will not be allowed throughout the study.
研究者
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