NCT04952064已完成4 期
Ganglioside GM1 in Acute Ischemic Stroke: a Prospective, Randomized, Blinded Assessment of Endpoints, and Multicenter Exploratory Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年7月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 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
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.
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
- Single (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；
- •5 ≤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
400 mg group
Experimental
Monosialoganglioside GM1, 400 mg/day, for 12-14 days
干预措施: Monosialoganglioside GM1 (Drug)
200 mg group
Experimental
Monosialoganglioside GM1, 200 mg/day, for 12-14 days
干预措施: Monosialoganglioside GM1 (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)
- changes in Barthel index (BI) scale(30 days and 90 days)
- changes in National Institute of Health stroke scale(7 days and 14 days)
研究者
Hui-Sheng Chen
Professor
General Hospital of Shenyang Military Region
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC PatientsNon-small Cell Lung CancerNCT01882621Sun Yat-sen University300
招募中
不适用
Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes MellitusIschemic StrokeType 2 Diabetes MellitusTransient Ischemic AttackNCT03948347First Affiliated Hospital of Jinan University1,708
已完成
3 期
Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal CancerChemotherapy-induced NeutropeniaColorectal CancerNCT02251977Yuhong Li196
招募中
3 期
GD-11 for Injection in the Treatment of Acute Ischemic StrokeAcute Ischemic StrokeNCT06299579Beijing Tiantan Hospital980
已完成
2 期
Ginsenoside-Rd for Acute Ischemic StrokeIschemic StrokeNCT00591084Xijing Hospital199