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NOT YET RECRUITING
NCT07721545
PHASE2/PHASE3

Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction

Sponsor: Neurodawn Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial of Y-6 Sublingual Tablets for the Treatment of Acute Perforator Artery Territory Infarction

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

944

Start Date

2026-08-31

Completion Date

2028-07-31

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DRUG

Y-6 tablet

Y-6 sublingual tablets (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days.

DRUG

Placebo

Placebo (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days.

Locations (1)

Beijing TianTan Hospital

Beijing, Beijing Municipality, China