An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

Phase 4

Completed

• Conditions: Stroke, Ischemic
• Interventions: Drug: Monosialoganglioside GM1

• Registration Number: NCT04952064
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-07
• Study Start: 2021-07-28
• Primary Completion: 2022-07-18
• Study Completion: 2022-07-18
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 mg group	Monosialoganglioside GM1	Monosialoganglioside GM1, 400 mg/day, for 12-14 days
200 mg group	Monosialoganglioside GM1	Monosialoganglioside GM1, 200 mg/day, for 12-14 days

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital of ShenYang Military Region; 🇨🇳 Shenyang, Liaoning, China