Trial Outcomes & Findings for Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome (NCT NCT02535611)
NCT ID: NCT02535611
Last Updated: 2020-10-06
Results Overview
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.
COMPLETED
PHASE3
47 participants
7 days
2020-10-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
20
|
|
Overall Study
COMPLETED
|
27
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome
Baseline characteristics by cohort
| Measure |
Memantine
n=27 Participants
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.
|
Placebo
n=20 Participants
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.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Continuous
|
71.56 years
STANDARD_DEVIATION 13.03 • n=5 Participants
|
69.75 years
STANDARD_DEVIATION 14.61 • n=7 Participants
|
70.79 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Iran
|
27 participants
n=5 Participants
|
20 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe 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.
Outcome measures
| Measure |
Memantine
n=27 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|
|
Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)
|
4.52 score on a scale
Standard Deviation 4.51
|
5.75 score on a scale
Standard Deviation 4.94
|
PRIMARY outcome
Timeframe: 7 daysThe 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.
Outcome measures
| Measure |
Memantine
n=27 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|
|
Investigation of Disability by Modified Rankin Scale (mRS)
|
2.89 score on a scale
Standard Deviation 0.75
|
2.55 score on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: 28 daysThe 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.
Outcome measures
| Measure |
Memantine
n=27 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|
|
Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)
|
3.42 score on a scale
Standard Deviation 2.96
|
4.4 score on a scale
Standard Deviation 3.98
|
SECONDARY outcome
Timeframe: 28 daysThe 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.
Outcome measures
| Measure |
Memantine
n=27 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|
|
Investigation of Disability by Modified Rankin Scale (mRS)
|
2.3 score on a scale
Standard Deviation 0.95
|
2.3 score on a scale
Standard Deviation 1.3
|
Adverse Events
Memantine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nasim Tabrizi
Mazandaran University of medical sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place