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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Safety Assessment
研究概览
简要总结
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.
详细描述
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)
盲法说明
Sponsor, Clinical Monitors
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Safety Assessment
时间窗: 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
次要结局
- Fugl-Meyer- Upper Extremity Motor Score (FMA-UE)(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)(Assessed as a continuous variable from baseline to Day 90)
- Modified Rankin Score (mRS)(Assessed as an ordinal variable from Baseline to Day 90)
- EuroQual-5D-5L Assessment (EQ-5D-5L)(Assessed as a continual variable from Baseline to Day 90)