An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase

Completed

Phase 4

Conditions

Stroke, Ischemic

Treatments

Drug: Monosialoganglioside GM1

Study type

Interventional

Funder types

Other

Identifiers

NCT04952064

Y（2021）052

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.