EUCTR2009-010661-23-IT进行中（未招募）不适用
MITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDY
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI0 个研究点开始时间: 2011年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-subjects must have a confirmed MS diagnosis as defined by the Revised McDonald criteria (Ann. Neurol. 58:840-846; 2005); - subjects must have a secondary-progressive form of MS (SPMS); -subjects must have a progression of at least 1 point on EDSS scale in the year before the inclusion; -subjects must be ambulatory with EDSS score <6; -subjects must be between 35-55 years of age; -subjects must have a LVEF >50%.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-use of immunosuppressive agents within one year prior to baseline; -corticosteroid treatment within 3 month prior to baseline; -subjects with clinically significant or unstable medical or surgical condition that preclude safe and complete study partecipation; -pregnancy; - cardiac abnormalities; - subjects with WBC < 4.0 x 103/μL.
研究者
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