Clinical trial NCT04952064: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke, Ischemic
Keywords: monosialoganglioside GM1
Ischemic Stroke
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
Collaborators: name: The Third Xiangya Hospital of Central South University
First posted: 2021-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of modified Rankin Scale (mRS) 0-2
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of modified Rankin Scale (mRS) 0-1
timeFrame: 90 days
measure: changes in National Institute of Health stroke scale
timeFrame: 7 days and 14 days
measure: changes in Barthel index (BI) scale
timeFrame: 30 days and 90 days
Other outcomes:
measure: changes in some serum biomarkers
timeFrame: 7 days and 14 days
measure: The change of infarct volume
timeFrame: 3 days
Locations:
city: Shenyang
country: China
facility: General Hospital of ShenYang Military Region
state: Liaoning
Study officials:
affiliation: General Hospital of Shenyang Military Region
name: Chen Huisheng, Doctor
role: STUDY_CHAIR
References: