Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNeurodawn Pharmaceutical Co., Ltd.
About this trial
The goal of this clinical trial is to learn if Y-6 sublingual tablets work to improve functional outcomes in patients with acute perforating artery infarction. It will also learn about the safety of Y-6 sublingual tablets.
The main questions it aims to answer are:
Does Y-6 sublingual tablets increase the proportion of participants who achieve a modified Rankin Scale (mRS) score of 0-1 at Day 90 after treatment? What medical problems do participants have when taking Y-6 sublingual tablets?
Researchers will compare different doses of Y-6 sublingual tablets and placebo to evaluate the effectiveness and safety of Y-6 sublingual tablets in patients with acute perforating artery infarction.
Participants will:
Take Y-6 sublingual tablets or placebo according to the assigned treatment regimen.
Visit the clinic for assessments of neurological function, functional outcomes, and safety during the study period.
Complete clinical assessments, including neurological examinations, laboratory tests, and other safety evaluations.
Be followed for functional outcomes and safety events after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged ≥18 and ≤80 years;
Onset of stroke within 72 hours before the first administration of study treatment;
Clinical symptoms and signs suggestive of an acute isolated perforating artery territory infarction (no cortical involvement, no multifocal involvement, NIHSS score between 4 and 15, and level of consciousness item 1a ≤1);
Pre-stroke modified Rankin Scale (mRS) score ≤1 before the current stroke onset;
Disqualifiers
Known allergy to any component of the investigational product or its excipients;
Ischemic stroke caused by large artery atherosclerosis, cardioembolism, arterial dissection, or vasculitis identified at screening;
History of intracranial hemorrhagic diseases within 3 months prior to screening, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
History of other active or major neurological diseases, including recurrent seizures, intracranial tumors, vascular malformations (including arteriovenous malformations, arterial malformations, cavernous malformations), untreated aneurysms >3 mm in diameter, etc.;
Trial design
Design model
Parallel
Treatments tested in this trial
Y-6 tablet
DrugY-6 sublingual tablets (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days.
Placebo
DrugPlacebo (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days.
Treatment groups
944 Participants
are divided into 2 treatment groupsGroup A: Y-6 tabletExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants achieving a modified Rankin Scale (mRS) score ≤1 after treatment
The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability.
Time frame
Day 90(+7 days)Secondary outcomes
1
Distribution of mRS scores after treatment
The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability.
Time frame
Day 90(+7 days)2
Proportion of participants with stroke-related disability after treatment
Stroke disability is defined as disability (modified Rankin Scale \[mRS\] score of 3-5), major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and vascular death, and all-cause mortality.
Time frame
Day90 (+7 days)3
Change from baseline in NIHSS (National Institutes of Health Stroke Scale) scores at each assessment time point
The NIHSS total score ranges from 0 to 42, with higher scores indicating worse neurological outcomes.
Time frame
Day90 (+7 days)4
Proportion of participants achieving a Barthel Index score ≥95 after treatment
The Barthel Index (BI) is a measure of activities of daily living, with scores ranging from 0 to 100. Higher scores indicate greater independence, while lower scores indicate greater dependence on assistance for daily activities.
Time frame
Day 90 (+7 days)Other outcomes
1
Distribution of mRS scores after treatment
The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability.
Time frame
Day 180 (±10 days)、Day 360 (±15 days)2
Proportion of participants with stroke-related disability after treatment
Stroke disability is defined as disability (modified Rankin Scale \[mRS\] score of 3-5), major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and vascular death, and all-cause mortality.
Time frame
Day 180 (±10 days)、Day 360 (±15 days)3
Proportion of participants achieving a Barthel Index score ≥95 after treatment
The Barthel Index (BI) is a measure of activities of daily living, with scores ranging from 0 to 100. Higher scores indicate greater independence, while lower scores indicate greater dependence on assistance for daily activities.
Time frame
Day 180 (±10 days)、Day 360 (±15 days)4
Proportion of participants with ischemic stroke after treatment
Time frame
Day 180 (±10 days)、Day 360 (±15 days)Sponsors and contacts
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Source ClinicalTrials.gov
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