A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke
Overview
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.
Information coming soon.
Sex: ALL
Minimum Age: 18 Years
Healthy Volunteers: No
Age Groups: ADULT, OLDER_ADULT
Inclusion Criteria:
Informed Consent:
1. The participant or legally authorized representative has provided informed consent or deferred consent eligibility confirmed before the initiation of any trial procedures.
Age:
2. 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:
3. Clinical diagnosis of AIS.
4. 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.
5. 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).
6. Estimated Modified Rankin Scale score less than (130 kilograms (kg) or =185 millimeters of mercury [mmHg] or diastolic >=110 mm Hg) prior to randomization.
22. Blood glucose 400 mg/dL.
Current Medical Conditions:
23. Active, uncontrolled bleeding.
24. Bleeding diathesis or any other conditions that would pose significant bleeding risk.
25. Inability to undergo MRI or CT.
26. Chronic causative intracranial occlusion.
27. Causative total occlusion of the extracranial ICA.
28. Evidence of septic emboli or bacterial endocarditis.
29. Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator.
30. Pregnancy, lactation, or unable to comply with birth control methods or abstinence as specified in the protocol in the opinion of the investigator.
Imaging:
31. Poor quality imaging that precludes interpretation according to trial protocol.
32. Evidence of significant intracranial mass effect or midline shift.
33. Evidence of acute occlusion in >1 vascular territory (right/left MCA, right/left ACA, right/left PCA); multiple occlusions within the same vascular territory are allowed.
34. Evidence of acute or chronic intracranial hemorrhage (presence of chronic cerebral microbleeds on magnetic resonance imaging [MRI]) T2*-weighted type sequence (such as gradient recalled echo [GRE] or susceptibility weighted imaging [SWI]) is not exclusionary if total <10 and not consistent with diagnosis of cerebral amyloid angiopathy).
35. Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory or evidence of well-demarcated hypoattenuation on computed tomography (CT), if performed, consistent with established infarction and judged by the investigator to correspond to the clinical symptoms of the index AIS.
36. Evidence of intracranial tumor (except incidental, small meningioma), cerebral aneurysm, or arteriovenous malformation.
Laboratory:
37. Platelet count <50,000/ cubic millimeters (mm^3).
Other:
38. Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.