A Phase 2 Double Blinded, Randomized, Placebo Controlled Dose Escalation Study to Evaluate the Efficacy and the Safety of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within an 18-hour Treatment Window
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Functional Outcome as measured by the difference in percent change in NIHSS from baseline to 90 days in patients treated with GM602 within 18 hours compared to treated with placebo as primary efficacy endpoint
研究概览
简要总结
The purpose of this research study is to determine whether the investigational drug GM602, is effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot blocking the flow of blood through one, or more of the blood vessels supplying the brain) when administered up to 18 hours after symptoms begin.
详细描述
Stroke is a serious and life threatening disease. About 85% of all strokes are ischemic, caused by a blood clot or plaque that blocks a blood vessel in the brain. The thrombolytic drug tissue plasminogen activator (tPA) is the only early treatment for acute ischemic stroke approved by the FDA. Treatment with tPA must be administered within three hours of the stroke onset. Furthermore, tPA treatment carries a recognized risk of bleeding in the brain. GM602 is an investigational drug that may act as a neuroprotectant in patients who have had a stroke. It is thought to stop cell death and reduce inflammation in the injured area of the brain. This study is designed to evaluate the safety and efficacy of GM602 administered intravenously to patients in three consecutive daily doses of 320 mg/dose or 480 mg/dose, the initial dose administered within 18 hours after onset of acute ischemic stroke in the Middle Cerebral artery region.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old
- •Be eligible for MRI or CT scan
- •Have suffered acute ischemic stroke in the middle cerebral artery (MCA) distribution, as verified by the Screening diffusion-weighted imaging (DWI) abnormality and Screening perfusion-weighted imaging pressure-work index (PWI ) abnormality
- •Have NIH Stroke Scale (NIHSS) score total score of 9-20 inclusive at screening
- •Have suffered acute ischemic stroke within 18 hours
- •Have been functionally independent with a Modified Rankin Score (mRS) of 0 or 1 prior to suffering stroke
- •Patients who received tPA or FDA approved mechanical device can also enroll
- •completed informed consent form
排除标准
- •Have history of stroke in the past 3 months
- •Cannot be evaluated using MRI/CT
- •Have stroke of the brainstem or cerebellum
- •Have clinical presentation consistent with acute MI by EKG criteria (STEMI) at screening
- •Have hemorrhage revealed by CT or MRI scan
- •Have > 1/3 MCA territory HYPER intensity as seen on MRI OR >1/3 MCA territory HYPO intensity as seen on CT
- •Have blood sugar level >400 mg/DL or<50 mg/dL
- •Have kidney disease, creatinine > 2.0
- •Have had recent (within 90 days) serious head trauma or head trauma with loss of consciousness
- •Have any prior history of seizure
- •Have clinically relevant pre-existing neurological deficit (Historical Rankin score ≥ 2)
- •Have any other known clinically significant medical disorder (cardiovascular, hepatic, renal, endocrine, respiratory, immunological, cancer, AIDS)
- •Life expectancy of less than 6 months due to comorbid conditions
- •Women of child bearing potential who are pregnant or breast-feeding or unable to practice birth control during the study period
- •Have participated in any other trial of an investigational agent within 90 days prior to screening
- •Informed consent cannot be obtained
- •Unable to participate in study visits
研究组 & 干预措施
GM602
First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or placebo in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 12 moderate and 12 severe patients will receive GM602.
干预措施: GM602 (Drug)
Placebo Comparator
First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or placebo in a 2:1 ratio; then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 6 moderate and 6 severe patients receive Placebo.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Functional Outcome as measured by the difference in percent change in NIHSS from baseline to 90 days in patients treated with GM602 within 18 hours compared to treated with placebo as primary efficacy endpoint
时间窗: Day 90
NIH Stroke Scale is a standardized neurological examination intended to describe the neurological deficits found in large groups of stroke patients participating in treatment trials. Percent change from baseline in NIHSS is calculated and compared.
次要结局
- Functional Outcome as measured by the difference in percent change in NIHSS from baseline to 30 days in patients treated with GM602 compared to treated with placebo(Day 30)
- Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 90 days(Day 90)
- Percent change in Barthel Index (BI) from baseline to 30 days in patients treated with GM602 compared to treated with placebo(Day 30)
- Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 30 days(Day 30)
- Secondary safety endpoint as measured by all cause mortality data through 3 months for patients treated with GM602 compared with placebo(Day 90)
- Percent change in Barthel Index (BI) from baseline to 90 days in patients treated with GM602 compared to treated with placebo(Day 90)