Multicenter, Randomized, Double-blind, Placebo-controlled Comparative Study of the Efficacy and Safety of the Drug Dimephosphon®, Concentrate for Solution for Intravenous Administration, 1 g, in Acute Ischemic Stroke Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 6
- 主要终点
- Percentage of subjects having Modified Rankin Scale (mRS) scores 0-2 at Visit 4 (Day 15)
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke
详细描述
This study is a multicenter, randomized, double-blind, placebo-controlled trial. The purpose of the study is to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke. The study includes a screening period (Visit 1, up to 48 hours) and a treatment period (Visits 2-4). Subjects will be randomized into 2 groups in a 1:1 ratio: Group A (investigational drug Dimephosphon®) and Group B (placebo). Key inclusion criteria: verified by CT/MRI current hemispheric ischemic stroke, NIHSS score ≥5 and ≤15 at screening. The study will assess clinical outcomes using standardized scales including NIHSS, mRS, MMSE, MoCA and EQ-5D.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.
- •Patients must exhibit neurological manifestations consistent with acute ischemic stroke, with a documented onset-to-intervention interval ranging from 24 to 72 hours at the time of scheduled initial administration of the investigational drug.
- •Verified by CT/MRI current hemispheric ischemic stroke.
- •NIHSS score ≥5 and ≤15 at screening.
- •Ability to comply with all protocol-specified procedures, prohibitions, and restrictions.
- •Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol.
排除标准
- •Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries
- •Vertebrobasilar stroke and/or development of acute insufficiency syndromes in the arteries of the vertebrobasilar system
- •A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.
- •The presence of anatomical abnormalities of the cerebral vessels (arteriovenous malformations, cavernous malformations, aneurysms, atresia of at least one of the extracranial arteries) according to the anamnesis or CT/MRI data.
- •Progression of neurological symptoms of stroke, defined as an increase in the NIHSS score by 4 points at the second assessment (immediately before randomization) from the value obtained at the first assessment (immediately after signing the informed consent form).
- •Surgery on the carotid arteries less than 1 year before screening.
- •History of stroke less than 1 year before screening.
- •Myocardial infarction less than 6 months before screening.
- •Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min).
- •Pregnancy or lactation.
- •Participation in another trial within 28 days prior to enrollment.
- •Use of prohibited medications.
研究组 & 干预措施
Dimephosphon®
Days 1-3: Dimephosphon® 2 g (2 vials) administered as intravenous infusion diluted in 200 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).
Days 4-14: Dimephosphon® 2 g (2 vials) administered as intravenous bolus diluted in 20 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).
干预措施: Dimephosphon® (Drug)
Placebo
Days 1-3: Placebo 2 g (2 vials) administered as intravenous infusion diluted in 200 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).
Days 4-14: Placebo 2 g (2 vials) administered as intravenous bolus diluted in 20 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects having Modified Rankin Scale (mRS) scores 0-2 at Visit 4 (Day 15)
时间窗: Day 15
次要结局
- Percentage of subjects having Modified Rankin Scale (mRS) scores 0-2 at Visit 3 (Day 8), Visit 5 (Day 30), Visit 6 (Day 90).(Day 8, Day 30, Day 90)
- Change from Baseline (Visit 1, no more than 48 hours) in the National Institutes of Health Stroke Scale (NIHSS) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).(Baseline, Day 8, Visit 4 Day 15, Day 30, Day 90)
- Percentage of subjects with changes from Baseline (Visit 1, no more than 48 hours) in NIHSS score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).(Baseline, Day 8, Day 15, Day 30, Day 90)
- Proportion of patients with a ≥4-point change in NIHSS score from Baseline (Visit 1, no more than 48 hours) at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), and Visit 6 (Day 90).(Baseline, Day 8, Day 15, Day 30, Day 90)
- Proportion of patients with a ≥2-point change in NIHSS score from Baseline (Visit 1, no more than 48 hours) to Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).(Baseline, Day 8, Day 15, Day 30, Day 90)
- Change from Baseline (Visit 1, no more than 48 hours) in the Montreal Cognitive Assessment (MoCA) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).(Baseline, Day 8, Day 15, Day 30, Day 90)
- Change from Baseline (Visit 1, no more than 48 hours) in the Mini-Mental State Examination (MMSE) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).(Baseline, Day 8, Day 15, Day 30, Day 90)
- Change from Baseline (Visit 1, no more than 48 hours) in the EuroQol 5-Dimensions (EQ-5D) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).(Baseline, Day 8, Day 15, Day 30, Day 90)
- All-cause mortality from Visit 2 to Visit 6 (Hazard Ratio)(up to Day 90)