Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

Ischemic Stroke Clinical Trial

— EMISO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535611
• Other study ID #: MAZUMS
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2020
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Excitotoxicity
• Ischemia
• Ischemic Stroke
• Memantine
• Stroke

Intervention

Drug:
• Placebo
Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.
• Memantine
Beside the usual treatment for ischemic stroke this group will be treated by memantine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	7 days
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.; - 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	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
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.; - 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