Phase 2 Trial to Test Safety and Effectiveness of TAK-755 in Adults with Acute Ischemic Stroke Randomized, Double-Blind, Placebo-Controlled Study

What this Trial Is About

Acute ischemic stroke AIS is a sudden medical emergency caused by a blockage of blood flow to the brain, either from a clot forming in the vessel or a clot traveling from elsewhere. This trial studies TAK-755, a biological treatment, to evaluate its safety and tolerability in adults with AIS. The study also aims to see if TAK-755 helps reduce the severity of stroke symptoms and supports daily activities compared to a placebo, while participants continue to receive usual hospital care. Participants will receive a single intravenous infusion of TAK-755 or a matching placebo on Day 1 in two parts of the study. After the infusion, all participants will be followed for about 90 days to monitor their health and recovery. The study uses a randomized, double-blind design where neither participants nor researchers know who receives TAK-755 or placebo. During the study, participants will be assessed for safety outcomes such as symptomatic intracranial hemorrhage within 120 hours of treatment. Researchers will also evaluate stroke scales like the Modified Rankin Scale and NIH Stroke Scale at various times, including 24 hours and 90 days post-infusion. Other monitoring includes imaging to check brain blood flow and infarct volume, laboratory tests, and tracking adverse events throughout the 90-day follow-up period.

A Study of TAK-755 in Adults With Acute Ischemic Stroke