An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

Ganglioside GM1 in Acute Ischemic Stroke: a Prospective, Randomized, Blinded Assessment of Endpoints, and Multicenter Exploratory Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Drug: Monosialoganglioside GM1

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • General Hospital of Shenyang Military Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200 mg group; Monosialoganglioside GM1, 200 mg/day, for 12-14 days	Drug: Monosialoganglioside GM1; Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days; Other Names: GM1
Experimental: 400 mg group; Monosialoganglioside GM1, 400 mg/day, for 12-14 days	Drug: Monosialoganglioside GM1; Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days; Other Names: GM1

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in some serum biomarkers	serum biomarkers included SOD，BDNF，NGF，CRP，TNF-α，IL-6，IL-1β，VEGF，NO，MMP	7 days and 14 days
The change of infarct volume	The change of infarct volume showed by MRI compared with baseline	3 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Collaborators: The Third Xiangya Hospital of Central South University
• Investigators: Study Chair: Chen Huisheng, Doctor, General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Ischemic Stroke; monosialoganglioside GM1
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: Y（2021）052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No