An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

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.