Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

Study Overview
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Brief Summary
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The researchers aim to investigate the effect of memantine on stroke outcome in a randomized double-blind placebo-controlled clinical trial.

Conditions
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Ischemic Stroke, Excitotoxicity, Memantine

Intervention / Treatment
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* Drug: Placebo
* Drug: Memantine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presentation at first 24hrs of disease onset Confirmation of ischemic stroke in MCA territory by imaging. Accepted consent form Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Memantine<br>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. | Drug: Memantine<br>* Beside the usual treatment for ischemic stroke this group will be treated by memantine.<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS) | 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. | 7 days | 
| Investigation of Disability by Modified Rankin Scale (mRS) | 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. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS) | 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. | 28 days | 
| Investigation of Disability by Modified Rankin Scale (mRS) | 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. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | 28 days |