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NCT07392450
A Study of TAK-755 in Adults With Acute Ischemic Stroke
Conditions: Acute Ischemic Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 222
Sponsor: Takeda
Location: HonorHealth Neurology Scottsdale Arizona
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07392450). StuddyBuddy aggregates publicly available trial information.