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 or deferred consent eligibility confirmed before the initiation of any trial procedures.
• Age:
• greater than and equal to (\>=) 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF) or confirmation of deferred consent eligibility.
• Clinical Characteristics:
• Clinical diagnosis of AIS.
• Onset of stroke symptoms within 24 hours of randomization. Wake-up strokes may be included if Last Known Well is within 24 hours of randomization; time of onset will be considered the time of Last Known Well.
• National Institutes of Health Stroke Scale score of 5 to 25, indicating moderate to severe stroke. Participants with an NIHSS score of 5 are eligible only if at least 1 predefined disabling neurological deficit is present, as defined by one or more of the following
• NIHSS criteria:
⁃ Complete hemianopia (NIHSS visual score \>=2).
⁃ Aphasia impairing meaningful communication (NIHSS language score \>=2).
⁃ Motor deficit with inability to sustain effort against gravity (NIHSS left or right motor arm or leg score \>=2).
• Estimated Modified Rankin Scale score less than (\<) 2 prior to AIS presentation, signifying no significant disability.
• Persistent neurological signs and symptoms consistent with unilateral supratentorial circulation stroke.
• Imaging:
• Evidence of causative AIS occlusions affecting supratentorial circulation on imaging (intracranial internal carotid artery \[ICA\], middle cerebral artery \[MCA; M1 - M4\], anterior cerebral artery \[ACA; A1 - A3\], posterior cerebral artery \[PCA; P1 - P3\]).
• Evidence of salvageable brain tissue on CT or MR imaging.