A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Monosialoganglioside in the Treatment of Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,232
- 试验地点
- 1
- 主要终点
- Proportion of modified Rankin Scale (mRS) 0-2
研究概览
简要总结
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design is used to evaluate the efficacy and safety of GM1 injection in the treatment of patients with acute ischemic stroke.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old；
- •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.
排除标准
- •Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration);
- •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.
研究组 & 干预措施
Monosialoganglioside
Monosialoganglioside GM1, 200 mg/day, for 12-14 days
干预措施: Monosialoganglioside (Drug)
Placebo
Placebo, for 12-14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of modified Rankin Scale (mRS) 0-2
时间窗: 90 days
the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome
次要结局
- Proportion of modified Rankin Scale (mRS) 0-1(90 days)