EUCTR2009-013841-27-DK进行中（未招募）不适用
A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Written informed consent obtained from the subject prior to any study-related
- •procedures and study product administration.
- •2. Diagnosis of definite or probable MMN based on the criteria of the American
- •Association of Electrodiagnostic Medicine.
- •Conduction block can be defined by a drop in amplitude. Diagnosis can be based
- •on chart records
- •a. Hand grip (finger flexor) weakness of Medical Research Council (MRC) grade 4
- •or less or equivalent, at disease onset or appearing prior to screening.
- •b. No upper motor signs.
- •c. No bulbar or cranial signs or symptoms.
- •d. No clinically identifiable sensory abnormalities.
- •3. Must be on a stable regimen of IGIV for at least 3 months prior to enrollment.
- •4. Treatment interval with IGIV of 2 to 5 weeks (+/- 3 days).
- •5. Dose of IGIV to be 0.4 to 2.0 g per kg bodyweight (BW) and infusion cycle.
- •6. Subjects are adults, male of female, at least 18 years of age.
- •7. If female and capable of bearing children - have a negative urine pregnancy test
- •result at enrollment and agree to employ adequate birth control measures for the
- •duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any clinical or electrophysiological evidence of coexisting neuropathy which may
- •interfere with outcome assessments, such as diabetic neuropathy, toxic
- •neuropathy, or neuropathy due to systemic lupus erythematosis.
- •2. Treatment with other immunosuppressive agents besides IGIV, which have
- •demonstrated efficacy in MMN such as cyclophosphamide during the 3 months
- •prior to enrollment (or treatment with Rituximab during the 12 months prior to
- •enrollment). Pre-study treatment with mycophenolate mofetil or azathioprine is
- •permitted if the dose has been stable for 3 months prior to enrollment.
- •3. Cerebrospinal fluid protein > 100 mg/dL (if done as part of a previous
- •evaluation).
- •4. Subjects positive at enrollment for Hepatitis B surface antigen, PCR for HCV,
- •and/or PCR for HIV Type 1.
- •5. Subjects with levels of alanine aminotransferase (ALT) or aspartate
- •aminotransferase (ASP) > 2.5 times the upper limit of normal.
- •6. Subjects with neutropenia (defined as an absolute neutrophil count [ANC]
- •<= 1000/mm³)
- •7. Subjects with serum creatinine levels greater than 1.5 times the upper limit of
- •8. Subjects with malignancy other than adequately treated basal cell or squameous
- •cell carcinoma of the skin or carcinoma in situ of the cervix.
- •9. Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial
- •infarction, cerebrovascular accident).
- •10. Subjects with an ongoing hypersensitivity or persistent reactions (urticaria,
- •breathing difficulty, severe hypotension, or anaphylaxis) following IGIV.
- •11. Subjects with immunoglobulin A deficiency and known anti-IgA antibodies.
- •12. If female, is pregnant or lactating at time of enrollment.
研究者
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