EUCTR2013-001150-10-CZ进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 143
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
- •- Male or female patient = 18 years old
- •- Diagnosis of NMO or NMO spectrum disorder
- •- NMO-IgG seropositive
- •- Historical Relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months, with at least 1 relapse in the 12 months prior to the Screening
- •- EDSS score =7
- •- Immunosuppressive therapy is allowed provided patients have been on
- •a stable maintenance dose prior to the Screening and remain on a stable dose for the duration of the study
- •- Patients must be willing and able to give written informed consent
- •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 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •- Use of rituximab or mitoxantrone within 3 months prior to screening
- •- Use of IVIg within 3 weeks prior to screening
研究者
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