An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952064
• Other study ID #: Y(2021)052
• Status: Completed
• Phase: Phase 4
• Start date: July 28, 2021
• Est. completion date: July 18, 2022

Study information

• Verified date: September 2022
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• Monosialoganglioside GM1
Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days

Locations

Country	Name	City	State
China	General Hospital of ShenYang Military Region	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region	The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in some serum biomarkers	serum biomarkers included SOD,BDNF,NGF,CRP,TNF-a,IL-6,IL-1ß,VEGF,NO,MMP	7 days and 14 days
Other	The change of infarct volume	The change of infarct volume showed by MRI compared with baseline	3 days
Primary	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	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
Secondary	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
Secondary	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