Monosialoganglioside in Acute Ischemic Stroke: a Randomized, Blinded and Multicenter Confirmatory Study

Inclusion criteria

• Age: 18-80 years old；
• Patients with anterior circulation cerebral infarction; first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)；
• Within 24 hours of onset；
• 7 ≤NIHSS score ≤ 20；
• Signed informed consent.

Exclusion criteria

• Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration);
• Hemorrhagic stroke;
• Disturbance of consciousness (NIHSS1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases;
• Planed endovascular treatment;
• Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg;
• Bleeding tendency (except for thrombolysis) or severe bleeding within 3 months;
• Patients with malignant tumor or serious diseases;
• Along with epilepsy, arthritis and other disease, which have effect on neurological assessment;
• History of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain Barre syndrome);
• Unable or unwilling to cooperate due to mental diseases;
• 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；
• Hypersensitivity to monosialoganglioside and excipients of test drug;
• History of drug abuse；
• Pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period;
• Participating in other clinical trials within 3 months;
• Other conditions which are unsuitable for this trial assessed by researcher.