Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Investigation of Disability by Modified Rankin Scale (mRS)
研究概览
简要总结
The researchers aim to investigate the effect of memantine on stroke outcome in a randomized double-blind placebo-controlled clinical trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presentation at first 24hrs of disease onset
- •Confirmation of ischemic stroke in MCA territory by imaging.
- •Accepted consent form
排除标准
- •Allergy history to memantine
- •Stage 4 -5 renal failure base on Acute Kidney Injury Network criteria
- •Moderate to severe hepatic failure (Child-Pugh criteria, grade B and C)
- •History of epilepsy
- •History of dementia
- •History of memantine use in recent 6 months
- •Pregnancy or breastfeeding
- •Severe drug adverse effects
研究组 & 干预措施
Memantine
Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive 20 mg/d(2 tab 5mg BID) memantine for 7 days and then 10mg/d(1 tab 5mg BID) memantine for 21 days.
干预措施: Memantine (Drug)
Placebo
Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive placebo(2 tab BID) for 7 days and continue placebo(1 tab BID) for 21 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Investigation of Disability by Modified Rankin Scale (mRS)
时间窗: 7 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.
Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)
时间窗: 7 days
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. Higher score is indicative of some level of impairment in neurological function.
次要结局
- Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)(28 days)
- Investigation of Disability by Modified Rankin Scale (mRS)(28 days)
研究者
Nasim Tabrizi
Assistant professor of neurology
Mazandaran University of Medical Sciences