A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke
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.
⁃ Informed Consent:
• The participant or legally authorized representative has provided informed consent before the initiation of any trial procedures.
• Age:
• 18 to 80 years of age, inclusive, at the time of signing the informed consent form.
• Clinical Characteristics:
• Clinical diagnosis of AIS.
• Onset of stroke symptoms within 24 hours of enrollment. Wake-up strokes may be included if Last Known Well is within 24 hours of enrollment; time of onset will be considered the time of Last Known Well.
• National Institutes of Health Stroke Scale score of 6 to 25, indicating moderate to severe stroke.
• Estimated Modified Rankin Scale score less than (\<) 2 prior to AIS presentation, signifying no significant disability.
• Signs and symptoms consistent with anterior circulation stroke.
• Imaging:
• Evidence of causative AIS occlusion on imaging (intracranial internal carotid artery \[ICA\], M1, M2, M3, M4, A1, A2, A3).
• Evidence of salvageable brain tissue on CT or MR imaging.