Stroke, Ischemic
Conditions
Keywords
monosialoganglioside GM1, Ischemic Stroke
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.
Interventions
DRUGMonosialoganglioside GM1
Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Sponsors
The Third Xiangya Hospital of Central South University
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| changes in some serum biomarkers | 7 days and 14 days | serum biomarkers included SOD，BDNF，NGF，CRP，TNF-α，IL-6，IL-1β，VEGF，NO，MMP |
| The change of infarct volume | 3 days | The change of infarct volume showed by MRI compared with baseline |
Countries
China
Outcome results
None listed