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New stroke drug aims to cut disability in first 3 hours

NCT ID NCT07520565

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether a single injection of BXOS110, given within 3 hours of an acute ischemic stroke, can reduce overall disability compared to a placebo. About 1112 adults aged 18-85 with moderate to severe stroke are being enrolled. The main goal is to see if more people achieve functional independence (mRS score 0-2) at 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BXOS110 injection
What this could lead to
If successful, this could provide a new treatment option to reduce long-term disability after a stroke.
What could go wrong
This is a single-dose study in a narrow 3-hour window, so many patients may not benefit. The trial is still recruiting, and results are not yet known.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,112 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 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: 1. Age18\~85 (including 18 and 85 years),no gender limitation; 2. Subjects diagnosed with acute ischaemic stroke according to the Chinese Guidelines for Clinical Management of Cerebrovascular Disease (2nd edition); 3. 8 ≤ NIHSS score ≤ 25 before randomisation,and the sum of the score of the 5th upper limb and the 6th lower limb was ≥ 2 ; 4. Within 3h of stroke onset and expected to be able to start receiving the investigational product within 3 h of stroke onset (note: stroke onset time was calculated from the onset time of stroke symptoms; if stroke onset occurs during sleep, the stroke onset time should be taken as the latest normal appearance time); 5. First stroke onset, or have a history of stroke but good prognosis (mRS score ≤1); 6. Subjects who are able to understand and comply with the study procedures, and who agree to sign the study informed consent form in writing to indicate that they are willing to participate in the trial (the informed consent form can be signed by subjects or their legal representatives). Exclusion Criteria: 1. Imaging confirmed intracranial hemorrhagic disease (hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.); 2. Severe disturbance of consciousness: NIHSS 1a score ≥2 points; 3. After aggressive antihypertensive therapy, hypertension still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥110 mmHg; 4. Severe hyperglycemia/hypoglycemia: blood glucose≥400 mg/dL (22.2 mmol/L), or ≤50 mg/dL (2.8 mmol/L); 5. Heart rate \< 50 beats /min or heart rate \> 120 beats /min; Heart failure, unstable angina pectoris, acute myocardial infarction, and severe arrhythmias within the previous 6 months; 6. Previously diagnosed severe hepatic and renal dysfunction and determined by the investigators as affect the subjects; 7. Patients who have suffered from malignant tumors or are undergoing anti-tumor treatment within the past 5 years; 8. Patients who have been treated with neuroprotective agents after current stoke onset; 9. Have a epilepsy history or have epilepsy symptoms after current stoke onset; 10. Combined with other mental illnesses, resulting in inability or unwillingness to cooperate; 11. Combined with claudication, osteoarthropathy, etc., resulting in limb movement dysfunction, which is determined by investigators to affect neurological function test; 12. History of severe head trauma or stroke within 3 months before screening; 13. History of severe food or drug allergy, or known allergy to the investigational drug and its excipients; 14. Expected survival period is less than 3 months; 15. Pregnant, planning pregnancy or breastfeeding patients; 16. Suspected or confirmed history of alcohol or drug abuse; 17. Participated in other drug or device clinical trial within the 1 months prior to screening or are participating in a other clinical trial; 18. Other conditions, and the investigator assessed that participation in the study might increase the patient's risk or that participation in the study was deemed inappropriate by the investigator.

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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

    9 sites. 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

  • Beijing Tiantan Hospital , Capital Medical University

    NOT_YET_RECRUITING

    Beijing, China

  • Daqing Oilfield General Hospital

    RECRUITING

    Daqing, Heilongjiang, China

  • Harrison International Peace Hospital

    RECRUITING

    Hengshui, Hebei, China

  • Linfen Central Hospital

    NOT_YET_RECRUITING

    Linfen, Shanxi, China

  • Linyi People's Hospital

    RECRUITING

    Linyi, Shandong, China

  • MeiHekou Central Hospital

    RECRUITING

    Meihekou, Jilin, China

  • The Affiliated Hospital of Shenyang Medical College

    RECRUITING

    Shenyang, Liaoning, China

  • The First Affiliated Hospital of Nanyang Medicinal College

    RECRUITING

    Nanyang, Henan, China

  • Xianyang Hospital of Yan'an University

    RECRUITING

    Xianyang, Shaanxi, China

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