A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
研究概览
简要总结
This study is randomized, double-blind, placebo-controlled Phase I/II study designed to evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation for intrathecal injection, as a treatment for acute spinal cord injury. The study is conducted at two clinical sites in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 18 years and equal to or less than 75 years
- •Cervical spinal cord injury, and Grade A, B1 or B2 in the modified Frankel Scale at 72 hours since the injury
- •Subjects able to provide written informed concent, which may require a relative to sign if arm/hand function of the subject is compromised
排除标准
- •Spinal cord injury at C1-C2 0r C2-C3 level
- •Patients not to able to start rehabilitation within a week by setup of respirator or other reason
- •First dose of the study drug will not be given within 78 hours since the injury
- •History of spinal cord injury or abnormality in spinal cavity. Or current considerable meningeal damage
- •Outcome assessment will not be conducted adequately through damage on injuries other than the injury
- •High-dose steroid therapy within 30 days before the entry
- •Patients who have diseases such as serious liver disorder, renal disorder, hear disease, blood dyscrasia, metabolism disorder and infections
- •History of malignant tumor
- •Patients who participated in other clinical study within 30 days before the entry
- •Patients who have allergies to drug scheduled to be used in the study
- •Administration of the study drug to the area of spinal cord injury is not appropriate for example by intrathecal infections or intrathecal tumor
- •Patients not able to understand "informed consent" properly
- •Patients who are nursing or may be pregnant
- •Investigator considers that the patient is not appropriate for participating in the study
研究组 & 干预措施
KP-100IT
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
干预措施: KP-100IT (Drug)
Placebo
Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times
干预措施: Placebo (Drug)
结局指标
主要结局
Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
时间窗: 24 weeks
Number and degree of adverse events
时间窗: 24 weeks
Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation
次要结局
- Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid(6 weeks)
- Change of ASIA motor score from baseline at 12 weeks(12 weeks)
- Time-dependent change of ASIA motor score from baseline(24 weeks)
- Time-dependent change of ASIA sensory score from baseline(24 weeks)
- Time-dependent grade change of modified Frankel scale from baseline(24 weeks)