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
Qualifiers
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
Treatments tested in this trial
- Y-6 tablet
- Placebo
Treatment groups
944 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov