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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Intravenous NTS-521
0.9% saline solution delivered intravenously
Safety Assessment
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
Time frame: Safety assessments between baseline and Day 30 and Day 90
Fugl-Meyer- Upper Extremity Motor Score (FMA-UE)
Change from baseline to Day 90 in the FMA-UE motor score (0-66; higher is better)
Time frame: 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)
National Institutes of Health Stroke Scale (0-42; higher is worse)
Time frame: Assessed as a continuous variable from baseline to Day 90
Modified Rankin Score (mRS)
Modified Rankin Score (mRS) (0-6; higher is worse), assessed as an ordinal variable
Time frame: Assessed as an ordinal variable from Baseline to Day 90
EuroQual-5D-5L Assessment (EQ-5D-5L)
Change from baseline to Day 90 for EQ-5D-5L Quality of Life Assessment Score (5 to 25, lower indicating better quality of life)
Time frame: Assessed as a continual variable from Baseline to Day 90
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