NCT07722962尚未招募3 期
An Additional Phase 3, Multicenter Study of Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration, 24 weeks
研究概览
简要总结
This is a Phase 3, multicenter, open-label, single-arm additional study to evaluate the efficacy of intrathecal KP-100IT in patients with acute spinal cord injury. Eligible patients will receive KP-100 0.6 mg/body by intrathecal administration once per week for a total of 5 doses and will be followed for approximately 24 weeks after the first dose.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose AIS grade is A at 72 hours (± 6 hours) after injury
- •age: 18 years to 89 years
- •MRI imaging and other tests confirm the continuity of the spinal cord
排除标准
- •The injury site is C1-C2 or C2-C3
- •The patient with a spinal crd compression rate of 70% or higher.
- •The patient in whom a spinal cord rupture is strongle suspected.
- •The patient cannot start rehabilitation necessary for recovery of function at an early stage.
- •External trauma or concurrent organ injury.
- •High dose steroid therapy administered for the treatment of spinal cord injury
- •History or concurrent presence of malignant tumor.
- •It is inappropriate for the subject to be included in the study, in the opinion of the investigator.
结局指标
主要结局
Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration, 24 weeks
时间窗: 24 weeks after investigational product administration
次要结局
- Time course of ASIA sensory score(From baseline through 24 weeks)
- Time course of AIS classification(From baseline through 24 weeks)
- Time course of modified Frankel classification(From baseline through 24 weeks)
- Time course of neurological level of injury(From baseline through 24 weeks)
- Evaluation of adverse events(From the first drug administration through the end of the observation period (24 weeks))
- Time course of ASIA motor score (total/ upper extremity / lower upper extremity)(From baseline through 24 weeks)
- Percentage of subjects improving by at least 5 and 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration(12 weeks and 24 weeks after investigational product administration)
- Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100 after intrathecal administration(From dosing through 24weeks)
研究者
研究点 (3)
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