EUCTR2012-004807-10-DE进行中（未招募）1 期
Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis
niversity Medical Center Hamburg Eppendorf0 个研究点目标入组 40 人开始时间: 2012年10月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •oOptic neuritis with visual acuity < 0.7 after steroid treatment (3-5x1g)
- •oDuration of symptoms from onset < 4 weeks
- •oAge: 18-60 years
- •oEDSS: 1.0 – 6.5
- •oCIS, RR-MS or SP-MS
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •oabsence of evidence of inflammatory activity which is defined as a lack of inflammatory CSF signs (pleocytosis and/or OCBs) or a present MRI without at least 2 MS-typical lesions
- •obilateral optic neuritis
- •ocurrent treatment with natalizumab
- •opatients with neuromyelitis optica
- •oUnwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient returning for follow-up visits on schedule.
- •oPatients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol
研究者
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