An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: General Hospital of Shenyang Military Region
• Collaborator: The Third Xiangya Hospital of Central South University

Criteria

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.