Efficacy and Safety of Edaravone Dexborneol Sublingual Tablet for Post-stroke Cognitive Impairment in Patients With Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Exploratory Phase II Clinical Trial.
This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial. The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke. Participants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo.
• Age ≥ 40 years and ≤ 80 years, male or female.
• Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).
• The National Institutes of Stroke Scale score ≤ 20 points.
• Time from onset to obtained informed consent form is within 7 days (including 7 days).
• Presence of cognitive dysfunction at screening, i.e., MoCA scale score \< 22.
• Patients with good cognitive function prior to stroke, without significant cognitive dysfunction and dementia.
• Education level: primary school or above, and can complete the cognitive function test required per investigator's judgement.
• female subjects of childbearing potential and male subjects whose female partners are of childbearing potential must be willing to and use contraception during the study treatment and within 30 days after the last dose of study drug and have no plans to donate sperm or eggs; female subjects of childbearing potential will have a negative pregnancy test;
• obtain voluntary signed informed consent from the patient or his/her legal representative approved by the Ethics Committee.