jRCT2071240022进行中（未招募）不适用
Japan Expanded Clinical Study (ECS) to Provide Tofersen (BIIB067) to Patients With Amyotrophic Lateral Sclerosis (ALS) Associated with a Mutation in the Superoxide Dismutase 1 (SOD1) Gene
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Weakness attributable to ALS and associated with a mutation in the SOD1 gene (SOD1-ALS).
排除标准
- •Any comorbidities or conditions that, in the opinion of the Investigator, would unacceptably increase the risk of participation, including contraindications to lumbar punctures (LPs).
- •Anticipated need, in the opinion of the Investigator, for administration of any antiplatelet or anticoagulant medication that cannot be safely held before and/or after an LP procedure according to local or institutional guidelines and/or Investigator determination.
- •Treatment with another investigational drug, biological agent (excluding tofersen), or device within 1 month or 5 half-lives of study agent, whichever is longer, before the first dose of tofersen in this study.
- •Female participants who are pregnant or breastfeeding.
- •Patient's primary place of residence is outside of the country of treatment.
结局指标
主要结局
-
Adverse event assessment
次要结局
未报告次要终点
研究者
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