Monosialoganglioside in Acute Ischemic Stroke: a Randomized, Blinded and Multicenter Confirmatory Study
NCT ID: NCT06742216
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1232 participants
INTERVENTIONAL
2020-11-03
2023-08-30
Brief Summary
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It is estimated that 1706 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 1:1 ratio. Normally, the duration of this study is approximately 90 days.
Treatment was continued for 12\~14 days, and follow-up was conducted until the 90th day from the first dose.
The trial is divided into three phases: screening/baseline phase, treatment phase, and follow-up phase.
Screening/baseline period: After the subjects sign the informed consent form, they enter the screening/baseline period for screening examination.
Treatment period: Qualified subjects are randomly divided into groups in a 1:1 ratio and receive continuous treatment for 12\~14 days (12\~14 times) with GM1 injection and placebo respectively. During the treatment period, relevant examinations and evaluations required by the protocol will be carried out.
Follow-up period: Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Monosialoganglioside
Monosialoganglioside GM1, 200 mg/day, for 12-14 days
Monosialoganglioside
Monosialoganglioside diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Placebo
Placebo, for 12-14 days
Placebo
Placebo diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Interventions
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Monosialoganglioside
Monosialoganglioside diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Placebo
Placebo diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Eligibility Criteria
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Inclusion Criteria
* Patients with anterior circulation cerebral infarction; first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)；
* Within 24 hours of onset；
* 7 ≤NIHSS score ≤ 20；
* Signed informed consent.
Exclusion Criteria
* Hemorrhagic stroke;
* Disturbance of consciousness (NIHSS1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases;
* Planed endovascular treatment;
* Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg;
* Bleeding tendency (except for thrombolysis) or severe bleeding within 3 months;
* Patients with malignant tumor or serious diseases;
* Along with epilepsy, arthritis and other disease, which have effect on neurological assessment;
* History of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain Barre syndrome);
* Unable or unwilling to cooperate due to mental diseases;
* 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；
* Hypersensitivity to monosialoganglioside and excipients of test drug;
* History of drug abuse；
* Pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period;
* Participating in other clinical trials within 3 months;
* Other conditions which are unsuitable for this trial assessed by researcher.
18 Years
80 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Nanjing Gulou Medical College Affiliated Hospital
Nanjing, , China
Countries
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Other Identifiers
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QLGM1-AIS-301
Identifier Type: -
Identifier Source: org_study_id