Stroke drug given during ambulance ride could boost recovery
NCT ID NCT07682922
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial tests whether a sublingual (under-the-tongue) tablet of edaravone dexborneol, given within 6 hours of stroke onset during transfer between hospitals, can improve functional recovery in people with acute ischemic stroke. About 1,040 participants will receive either the drug or a placebo. The main goal is to see if the drug reduces disability at 90 days, measured by the modified Rankin Scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Edaravone dexborneol sublingual tablet
- What this could lead to
- If it works, this could provide a fast, easy-to-give treatment during ambulance or helicopter transfer that improves functional recovery after a stroke.
- What could go wrong
- This is a Phase 4 trial, but the drug is still being tested for this specific use. It may not improve outcomes, and side effects are possible. The results will need confirmation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 1,040 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 18 to 80 years (inclusive). * Time from last known normal to arrival at the first hospital is within 6 hours. * Clinical and imaging diagnosis of acute ischemic stroke, with a Los Angeles Motor Scale (LAMS) score ≥ 4, or occlusion of the internal carotid artery, M1/M2 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery confirmed by CTA/MRA at the first or target hospital. * ASPECTS score ≥ 6 on non-contrast head CT at the first hospital. * Clinically assessed as planned for immediate transfer to a target hospital for evaluation of endovascular therapy (final decision on whether to perform EVT is made by the neuro-interventionist at the target hospital based on imaging and clinical status). * Written informed consent signed by the patient or their legal representative. Exclusion Criteria: * Allergy to contrast agents, nickel, titanium, or their alloys. * Known allergy to dexborneol, edaravone, or excipients. * Pre-stroke modified Rankin Scale (mRS) score ≥ 2. * Patients receiving intravenous thrombolysis alone. * Severe impairment of consciousness (e.g., GCS score \< 8) or inability to cooperate with sublingual administration. * Severe hepatic or renal insufficiency (e.g., ALT/AST \> 3 times the upper limit of normal, Cr \> 2 times the upper limit of normal). * Estimated inter-hospital transfer time \> 3 hours. * Pregnant or lactating women. * Arterial tortuosity and/or other arterial diseases where the thrombectomy device is expected to be unable to reach the target vessel. * Brain tumors with mass effect on imaging (except small meningiomas). * Currently participating in other drug clinical trials. * History of neurological or psychiatric diseases that hinder the assessment of neurological function. * Any late-stage disease with an expected life expectancy \< 6 months.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute ischemic stroke are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Xinqiao Hospital and The Second Affiliated Hospital
Chongqing, Chongqing Municipality, 400000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Glenzocimab in anterior stroke with large ischemic core eligible for endovascular therapy
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better
- Can a stroke drug shrink brain damage after clot removal?
- Can a new drug boost recovery after stroke surgery?
- Can a swift Clot-Buster boost stroke recovery?
- AI could forecast stroke outcomes in real time