Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients (NCT06315231) | Clinical Trial Compass
RecruitingPhase 2
Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients
China226 participantsStarted 2024-04-08
Plain-language summary
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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events
Timeframe: Until follow up 26 weeks or early termination
2
Number of discontinuation/withdrawal patients
Timeframe: Until follow up 26 weeks or early termination
3
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
. 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;
Exclusion criteria
. Presence of intracranial hemorrhagic disease confirmed by brain imaging.
. Severe disturbance of consciousness: NIHSS 1a level of consciousness item score \> 1 point.
. Transient ischemic attack (TIA).
. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.
. For subjects who are scheduled to undergo EEG examination, Patients with contraindications for EEG examination.
. Presence of cognitive dysfunction prior to stroke assessed by informants, that is, the average score of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, 16-item version) during the screening period was ≥ 3.19 and the total score was ≥ 51.