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An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

Sponsor
General Hospital of Shenyang Military Region (Other)
Overall Status
Recruiting
CT.gov ID
NCT04952064
Collaborator
The Third Xiangya Hospital of Central South University (Other)
300
Enrollment
1
Location
2
Arms
12.1
Anticipated Duration (Months)
24.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Monosialoganglioside GM1
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ganglioside GM1 in Acute Ischemic Stroke: a Prospective, Randomized, Blinded Assessment of Endpoints, and Multicenter Exploratory Study
Actual Study Start Date :
Jul 28, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. 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

    3. 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 Outcome Measures

    1. 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

    2. The change of infarct volume [3 days]

      The change of infarct volume showed by MRI compared with baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Age: 18-80 years old；
      1. Patients with anterior circulation cerebral infarction;
      1. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)；
      1. Within 24 hours of onset；
      1. 5 ≤NIHSS score ≤ 20；
      1. Signed informed consent.
    Exclusion Criteria:
      1. Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration);
      1. Hemorrhagic stroke;
      1. Disturbance of consciousness (NIHSS1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases;
      1. Planed endovascular treatment;
      1. Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg;
      1. Bleeding tendency (except for thrombolysis) or severe bleeding within 3 months;
      1. Patients with malignant tumor or serious diseases;
      1. Along with epilepsy, arthritis and other disease, which have effect on neurological assessment;
      1. History of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain Barre syndrome);
      1. Unable or unwilling to cooperate due to mental diseases;
      1. 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；
      1. Hypersensitivity to monosialoganglioside and excipients of test drug;
      1. History of drug abuse；
      1. Pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period;
      1. Participating in other clinical trials within 3 months;
      1. Other conditions which are unsuitable for this trial assessed by researcher.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital of ShenYang Military Region Shenyang Liaoning China

    Sponsors and Collaborators

    • General Hospital of Shenyang Military Region
    • The Third Xiangya Hospital of Central South University

    Investigators

    • Study Chair: Chen Huisheng, Doctor, General Hospital of Shenyang Military Region

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hui-Sheng Chen, Professor, General Hospital of Shenyang Military Region
    ClinicalTrials.gov Identifier:
    NCT04952064
    Other Study ID Numbers:
    • Y（2021）052
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Aug 12, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hui-Sheng Chen, Professor, General Hospital of Shenyang Military Region
    monosialoganglioside GM1
    Ischemic Stroke
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Ischemia

    Study Results

    No Results Posted as of Aug 12, 2021