Could a natural brain booster help stroke survivors walk again?
NCT ID NCT07519044
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 868 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: * 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Heze Municipal Hospital
RECRUITINGShandong, Heze, China
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Xuanwu Hospital, Capital Medical University.
RECRUITINGBeijing, Beijing Municipality, China
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