Stroke drug given during ambulance ride could boost recovery

NCT ID NCT07682922

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Our safety recommendation!

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.