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Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome (EMISO)

Primary Purpose

Ischemic Stroke, Excitotoxicity, Memantine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Memantine
Sponsored by
Mazandaran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Memantine

    Placebo

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    August 22, 2015
    Last Updated
    September 15, 2020
    Sponsor
    Mazandaran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02535611
    Brief Title
    Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome
    Acronym
    EMISO
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mazandaran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke, Excitotoxicity, Memantine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Memantine
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Memantine
    Intervention Description
    Beside the usual treatment for ischemic stroke this group will be treated by memantine.
    Primary Outcome Measure Information:
    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
    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
    Secondary Outcome Measure Information:
    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
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

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