A Phase 2a Study to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Pharmacokinetics of Intravenous NTS-521 Infusions in the Early Recovery Treatment From Acute Ischemic Stroke (ACT-IVATE)
2026年7月31日 更新者：NeuroTrauma Sciences, LLC
A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Domain Within the ACT-GLOBAL Trial Platform, to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Pharmacokinetics of Intravenous NTS-521 Infusions in the Early Recovery Treatment From Acute Ischemic Stroke
This is a trial to evaluate the safety and effect of three intravenous (IV) doses of NTS-521 for the early recovery treatment of acute ischemic stroke (AIS).
Participants will be followed for 90 days.
研究概览
详细说明
Stroke represents a major global public health crisis, characterized by a paradox: declining age-standardized rates yet a rapidly expanding absolute global burden. According to recent epidemiological analyses from the Global Burden of Disease (GBD) study there were 11.9 million incident strokes worldwide in 2021, corresponding to a global age-standardized incidence rate of 141.5 per 100,000 person-years. Stroke claimed 7.3 million lives (an age-standardized mortality rate of 87.4 per 100,000), making it the third leading cause of mortality worldwide, accounting for 10.7% of all deaths.
The trial's target population for NTS-521 intervention consists of participants undergoing endovascular thrombectomy (EVT), and/or intravenous thrombolysis (IVT), or medical care without reperfusion treatment.
研究类型
介入性
注册 (估计的)
140
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Scott C Oshana, BS
- 电话号码：18603022074
- 邮箱：s.oshana@neurotraumasciences.com
研究联系人备份
- 姓名：Allison Ward, MSA, MSEd
- 电话号码：910-616-8586
- 邮箱：a.ward@neurotraumasciences.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Acute ischemic stroke with moderate to severe hemiparesis
- Functional independence in activities of daily living without requiring nursing care before the index stroke.
- Consent process by participant or proxy, with reconsent provision.
- Age ≥ 45 to ≤ 80 years of age (inclusive) on the date of randomization
- Sufficient attention, comprehension, and cooperation to carry out instructions
Exclusion Criteria:
- Pre-existing motor deficit prior to index stroke
- Posterior circulation ischemic stroke
- Lacunar stroke
- Qualifying brain imaging demonstrating intracranial hemorrhage, malignant middle cerebral artery (MCA) infarct with edema, or bilateral/multifocal infarcts, clinically significant vascular malformation, brain tumor, or other central nervous system (CNS) pathology
- Recent major surgery or trauma (<30 days)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo 0.9% saline solution
0.9% saline solution
|
0.9% saline solution delivered intravenously
|
|
实验性的：Low Dose NTS-521
Low Dose NTS-521 in 0.9% saline delivered IV
|
Intravenous NTS-521
|
|
实验性的：Medium Dose NTS-521
Medium Dose NTS-521 in 0.9% saline delivered IV
|
Intravenous NTS-521
|
|
实验性的：High Dose NTS-521
High Dose NTS-521 in 0.9% saline delivered IV
|
Intravenous NTS-521
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety Assessment
大体时间：Safety assessments between baseline and Day 30 and Day 90
|
Count of incident adverse events by treatment arm, including Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reaction (SUSARs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI - CTCAE v6.0), Vital signs and electrocardiograph (ECG) assessed by descriptive statistics, shift tables, and normal range criteria, and standard biochemical and hematology laboratory panel, assessed by descriptive statistics, shift tables, and normal range criteria
|
Safety assessments between baseline and Day 30 and Day 90
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fugl-Meyer- Upper Extremity Motor Score (FMA-UE)
大体时间：Change from Baseline Total Fugl-Meyer-Upper Extremity Motor Score, assessed as a continuous variable to Day 90
|
Change from baseline to Day 90 in the FMA-UE motor score (0-66; higher is better)
|
Change from Baseline Total Fugl-Meyer-Upper Extremity Motor Score, assessed as a continuous variable to Day 90
|
|
National Institutes of Health Stroke Scale Assessment (NIHSS)
大体时间：Assessed as a continuous variable from baseline to Day 90
|
National Institutes of Health Stroke Scale (0-42; higher is worse)
|
Assessed as a continuous variable from baseline to Day 90
|
|
Modified Rankin Score (mRS)
大体时间：Assessed as an ordinal variable from Baseline to Day 90
|
Modified Rankin Score (mRS) (0-6; higher is worse), assessed as an ordinal variable
|
Assessed as an ordinal variable from Baseline to Day 90
|
|
EuroQual-5D-5L Assessment (EQ-5D-5L)
大体时间：Assessed as a continual variable from Baseline to Day 90
|
Change from baseline to Day 90 for EQ-5D-5L Quality of Life Assessment Score (5 to 25, lower indicating better quality of life)
|
Assessed as a continual variable from Baseline to Day 90
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bijoy A Menon, MD、The University of Calgary Stroke Program & Stroke Clinical Trial Group
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月31日
初级完成 (估计的)
2028年12月15日
研究完成 (估计的)
2028年12月15日
研究注册日期
首次提交
2026年7月27日
首先提交符合 QC 标准的
2026年7月31日
首次发布 (实际的)
2026年8月3日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月31日
最后验证
2026年7月1日
更多信息
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