Back to resultsAn Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke
Primary Purpose
Stroke, Ischemic
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Monosialoganglioside GM1
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic focused on measuring monosialoganglioside GM1, Ischemic Stroke
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.
Sites / Locations
- General Hospital of ShenYang Military Region
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
200 mg group
400 mg group
Arm Description
Monosialoganglioside GM1, 200 mg/day, for 12-14 days
Monosialoganglioside GM1, 400 mg/day, for 12-14 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
changes in Barthel index (BI) scale
the minimum and maximum values of BI are 0 and 100, respectively; higher BI mean a good outcome
Full Information
NCT ID
NCT04952064
First Posted
June 30, 2021
Last Updated
September 22, 2022
Sponsor
General Hospital of Shenyang Military Region
Collaborators
The Third Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04952064
Brief Title
An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke
Official Title
Ganglioside GM1 in Acute Ischemic Stroke: a Prospective, Randomized, Blinded Assessment of Endpoints, and Multicenter Exploratory Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region
Collaborators
The Third Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
monosialoganglioside GM1, Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
200 mg group
Arm Type
Experimental
Arm Description
Monosialoganglioside GM1, 200 mg/day, for 12-14 days
Arm Title
400 mg group
Arm Type
Experimental
Arm Description
Monosialoganglioside GM1, 400 mg/day, for 12-14 days
Intervention Type
Drug
Intervention Name(s)
Monosialoganglioside GM1
Other Intervention Name(s)
GM1
Intervention Description
Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Primary Outcome Measure Information:
Title
Proportion of modified Rankin Scale (mRS) 0-2
Description
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Proportion of modified Rankin Scale (mRS) 0-1
Description
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
Time Frame
90 days
Title
changes in National Institute of Health stroke scale
Description
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Time Frame
7 days and 14 days
Title
changes in Barthel index (BI) scale
Description
the minimum and maximum values of BI are 0 and 100, respectively; higher BI mean a good outcome
Time Frame
30 days and 90 days
Other Pre-specified Outcome Measures:
Title
changes in some serum biomarkers
Description
serum biomarkers included SOD，BDNF，NGF，CRP，TNF-α，IL-6，IL-1β，VEGF，NO，MMP
Time Frame
7 days and 14 days
Title
The change of infarct volume
Description
The change of infarct volume showed by MRI compared with baseline
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Huisheng, Doctor
Organizational Affiliation
General Hospital of Shenyang Military Region
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of ShenYang Military Region
City
Shenyang
State/Province
Liaoning
Country
China
12. IPD Sharing Statement
Learn more about this trial
An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke
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