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

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.

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)