An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the efficacy and safety of higher doses of monosialoganglioside GM1 injection in the treatment of patients with acute ischemic stroke.

Official Title
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Ganglioside GM1 in Acute Ischemic Stroke: a Prospective, Randomized, Blinded Assessment of Endpoints, and Multicenter Exploratory Study

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Drug: Monosialoganglioside GM1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age: 18-80 years old； 2. Patients with anterior circulation cerebral infarction; 3. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)； 4. Within 24 hours of onset； 5. 5 ≤NIHSS score ≤ 20； 6. Signed informed consent. Exclusion Criteria: 1. Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration); 2. Hemorrhagic stroke; 3. Disturbance of consciousness (NIHSS1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases; 4. Planed endovascular treatment; 5. Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg; 6. Bleeding tendency (except for thrombolysis) or severe bleeding within 3 months; 7. Patients with malignant tumor or serious diseases; 8. Along with epilepsy, arthritis and other disease, which have effect on neurological assessment; 9. History of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain Barre syndrome); 10. Unable or unwilling to cooperate due to mental diseases; 11. Abnormal liver and renal function: ALT, AST > 2 times of the upper limit of normal value, or Cr > 1.5 times of the upper limit of normal value； 12. Hypersensitivity to monosialoganglioside and excipients of test drug; 13. History of drug abuse； 14. Pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period; 15. Participating in other clinical trials within 3 months; 16. Other conditions which are unsuitable for this trial assessed by researcher.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg group<br>Monosialoganglioside GM1, 200 mg/day, for 12-14 days | Drug: Monosialoganglioside GM1<br>* Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days<br>* Other names: GM1;|
| Experimental: 400 mg group<br>Monosialoganglioside GM1, 400 mg/day, for 12-14 days | Drug: Monosialoganglioside GM1<br>* Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days<br>* Other names: GM1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of modified Rankin Scale (mRS) 0-2 | the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of modified Rankin Scale (mRS) 0-1 | the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome | 90 days | 
| changes in National Institute of Health stroke scale | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome | 7 days and 14 days | 
| changes in Barthel index (BI) scale | the minimum and maximum values of BI are 0 and 100, respectively; higher BI mean a good outcome | 30 days and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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monosialoganglioside GM1, Ischemic Stroke