A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

Summary

Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible. The main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking. The participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.

Eligibility

Age range

18–80 years

Sex

All

Healthy volunteers

No

Interventions

• Biological
  TAK-755

  TAK-755 IV infusion.

• Other
  Placebo

  TAK-755 matching placebo IV infusion.

Location