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Could a natural brain booster help stroke survivors walk again?

NCT ID NCT07519044

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding GM1, a natural brain substance, to standard clot-removal treatment helps people recover better after a severe stroke. About 868 adults in China who have a blocked artery in the front part of the brain will receive either GM1 or a placebo daily for up to 7 days. The goal is to see if more patients achieve independence in daily activities 90 days later.

What this could mean

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

Active substance
GM1 (a natural brain compound given as an IV infusion)
What this could lead to
If it works, this could mean better recovery and less disability for people who have a major stroke and undergo clot removal.
What could go wrong
This is a Phase 4 trial, but GM1's benefit specifically for clot-removal patients is unknown. The study is still recruiting, so results are not yet available.

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 868 people

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

Started

May 2026

Expected to finish

Aug 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: * 1.Age ≥18 years and ≤80 years * 2.Symptoms and signs consistent with anterior circulation ischemia; * 3.Computed tomography angiography (CTA) /magnetic resonance angiography (MRA) /digital subtraction angiography (DSA) confirmed occlusion of intracranial segment of internal carotid artery (ICA) or M1/M2 segments of the middle cerebral artery (MCA M1/M2); * 4.Acute ischemic stroke (AIS) selected for emergency endovascular treatment; * 5.Premorbid mRS ≤1; * 6.Time from symptom onset to randomization was within 24 hours, including patients with wake-up stroke or unwitnessed stroke; The time of symptom onset was defined as the Last Known Well (LKW); * 7.National Institutes of Health Stroke Score (NIHSS) ≥6 at admission; * 8.ASPECTS ≥3; * 9.Informed consent obtained from the patient or his/her legal representative. Exclusion Criteria: * 1.Simultaneous acute occlusion of large vessels in both the anterior and posterior circulation or bilateral cerebral hemispheres. * 2.Baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation; * 3.Seizures at stroke onset which would preclude obtaining a baseline NIHSS; * 4.Bilateral dilated pupils; * 5.Allergy to GM1 or excipients; * 6.Severe contrast allergy or absolute contraindication to iodinated contrast; * 7.Systolic pressure \>185 mmHg or diastolic pressure \>110 mmHg, and cannot be controlled by antihypertensive drugs; * 8.Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L); * 9.Platelet \<50\*10\^9/L; * 10.Known genetic or acquired bleeding diathesis, deficiency of anticoagulant factors, or oral anticoagulant drugs and INR \> 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours; * 11.Known Severe renal Failure as defined by a serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate (GFR) \<30, or patient requires hemodialysis or peritoneal dialysis; * 12.Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.); * 13.Presumed vasculitis or septic embolization; * 14.Suspicion of aortic dissection; * 15.Evidence indicates intracranial tumors (excluding small meningiomas), acute intracranial hemorrhage, tumors, or arteriovenous malformations (AVMs). * 16\. Significant mass effect causing midline shift. * 17\. The patient has neurological disease or mental disorder before onset, which affects the assessment of the condition; * 18.Females who are pregnant or in lactation; * 19.Hereditary glycolipid metabolic disorders (ganglioside storage diseases, such as familial amaurotic idiocy, retinal degenerative diseases); * 20.Autoimmune diseases, spine injuries, demyelinating diseases (e.g., Guillain-Barre syndrome) * 21.Participating in other clinical trials that could confound the evaluation of the study; * 22.Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients.

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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

    2 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

  • Heze Municipal Hospital

    RECRUITING

    Shandong, Heze, China

  • Xuanwu Hospital, Capital Medical University.

    RECRUITING

    Beijing, Beijing Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.