NCT03413319已完成1 期
Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
AbbVie2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年4月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject completed Study C2N-8E12-WW-104 (NCT02494024)
- •Subject was not eligible to enroll in Study M15-562 (NCT02985879)
排除标准
- •Subject weighs less than 35 kg at screening
- •Subject has any contraindication or inability to tolerate brain MRI
- •Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
研究组 & 干预措施
ABBV-8E12
Experimental
ABBV-8E12 administered by intravenous (IV) infusion.
干预措施: ABBV-8E12 (Drug)
结局指标
主要结局
Adverse Events
时间窗: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)
Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.
次要结局
未报告次要终点
研究者
研究点 (2)
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