Excitotoxicity, Ischemic Stroke, Memantine
Conditions
Brief summary
The researchers aim to investigate the effect of memantine on stroke outcome in a randomized double-blind placebo-controlled clinical trial.
Interventions
DRUGPlacebo
Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.
DRUGMemantine
Beside the usual treatment for ischemic stroke this group will be treated by memantine.
Sponsors
Mazandaran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS) | 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. |
| Investigation of Disability by Modified Rankin Scale (mRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS) | 28 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. |
| Investigation of Disability by Modified Rankin Scale (mRS) | 28 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Memantine: Beside the usual treatment for ischemic stroke this group will be treated by memantine. | 27 |
| 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.
Placebo: Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks. | 20 |
| Total | 47 |
Baseline characteristics
| Characteristic | Placebo | Memantine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 17 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 18 Participants |
| Age, Continuous | 69.75 years STANDARD_DEVIATION 14.61 | 71.56 years STANDARD_DEVIATION 13.03 | 70.79 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment Iran | 20 participants | 27 participants | 47 participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 21 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 20 |
| other Total, other adverse events | 0 / 27 | 0 / 20 |
| serious Total, serious adverse events | 0 / 27 | 0 / 20 |
Outcome results
Primary
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. 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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine | Investigation of Disability by Modified Rankin Scale (mRS) | 2.89 score on a scale | Standard Deviation 0.75 |
| Placebo | Investigation of Disability by Modified Rankin Scale (mRS) | 2.55 score on a scale | Standard Deviation 1.19 |
Primary
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine | Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS) | 4.52 score on a scale | Standard Deviation 4.51 |
| Placebo | Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS) | 5.75 score on a scale | Standard Deviation 4.94 |
Secondary
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. 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.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine | Investigation of Disability by Modified Rankin Scale (mRS) | 2.3 score on a scale | Standard Deviation 0.95 |
| Placebo | Investigation of Disability by Modified Rankin Scale (mRS) | 2.3 score on a scale | Standard Deviation 1.3 |
Secondary
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.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine | Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS) | 3.42 score on a scale | Standard Deviation 2.96 |
| Placebo | Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS) | 4.4 score on a scale | Standard Deviation 3.98 |