EUCTR2020-004708-32-ES进行中（未招募）1 期
A Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen - ONWARD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 152
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
- •- Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the study protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Treatment with another investigational therapy or enrollment in another interventional clinical study after the Day 302 visit in study 232SM203 (NCT04089566).
- •- Treatment with Zolgensma (all participants) after the Day 302 visit of study 232SM203 (NCT04089566). - Treatment with an approved therapy for SMA (other than Zolgensma) that is inconsistent with protocol requirements for allowed or disallowed concomitant therapies
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究者
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