An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

NCT ID: NCT04952064

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2022-07-18

Brief 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.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

200 mg group

Monosialoganglioside GM1, 200 mg/day, for 12-14 days

Group Type: EXPERIMENTAL

Monosialoganglioside GM1

Intervention Type: DRUG

Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days

400 mg group

Monosialoganglioside GM1, 400 mg/day, for 12-14 days

Group Type: EXPERIMENTAL

Monosialoganglioside GM1

Intervention Type: DRUG

Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days

Interventions

Monosialoganglioside GM1

Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days

Intervention Type: DRUG

Other Intervention Names

GM1

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Huisheng, Doctor

Role: STUDY_CHAIR

General Hospital of Shenyang Military Region

Locations

General Hospital of ShenYang Military Region

Shenyang, Liaoning, China

Countries

China

Other Identifiers

Y（2021）052

Identifier Type: -

Identifier Source: org_study_id