EMISO: Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

• Sponsor: Mazandaran University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02535611
• Collaborator: (none)
• Enrollment: 47
• Arms: 2
• Actual Duration (Months): 23

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke; Excitotoxicity; Memantine	Drug: Placebo; Drug: Memantine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Memantine; Beside the usual treatment for ischemic stroke this group will be treated by memantine.
Placebo Comparator: 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.	Drug: Placebo; Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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. - 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.

Secondary Outcome Measures

1. 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.

2. 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. - 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mazandaran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nasim Tabrizi, Assistant professor of neurology, Mazandaran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT02535611
• Other Study ID Numbers: MAZUMS
• First Posted: Aug 28, 2015
• Last Update Posted: Oct 6, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Ischemia; Memantine

Study Results

Participant Flow

Arm/Group Title	Memantine	Placebo
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	27	20
COMPLETED	27	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Memantine	Placebo	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	27	20	47
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 37%	8 40%	18 38.3%
>=65 years	17 63%	12 60%	29 61.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.56 (13.03)	69.75 (14.61)	70.79 (13.6)
Sex: Female, Male (Count of Participants)
Female	14 51.9%	7 35%	21 44.7%
Male	13 48.1%	13 65%	26 55.3%
Region of Enrollment (participants) [Number]
Iran	27 100%	20 100%	47 100%

Outcome Measures

1. Primary Outcome

Title	Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memantine	Placebo
Arm/Group Description	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.	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.
Measure Participants	27	20
Mean (Standard Deviation) [score on a scale]	4.52 (4.51)	5.75 (4.94)

2. Primary Outcome

Title	Investigation of Disability by Modified Rankin Scale (mRS)
Description	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.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memantine	Placebo
Arm/Group Description	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.	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.
Measure Participants	27	20
Mean (Standard Deviation) [score on a scale]	2.89 (0.75)	2.55 (1.19)

3. Secondary Outcome

Title	Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memantine	Placebo
Arm/Group Description	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.	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.
Measure Participants	27	20
Mean (Standard Deviation) [score on a scale]	3.42 (2.96)	4.4 (3.98)

4. Secondary Outcome

Title	Investigation of Disability by Modified Rankin Scale (mRS)
Description	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.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memantine	Placebo
Arm/Group Description	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.	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.
Measure Participants	27	20
Mean (Standard Deviation) [score on a scale]	2.3 (0.95)	2.3 (1.3)

Adverse Events

Time Frame	3 months
Arm/Group Title	Memantine		Placebo
Arm/Group Description	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.		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.
All Cause Mortality
	Memantine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/20 (0%)
Serious Adverse Events
	Memantine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Memantine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.