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Completed

NCT Number: NCT02535611

Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Excitotoxicity Memantine Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.

Memantine

Drug

Beside the usual treatment for ischemic stroke this group will be treated by memantine.

Primary outcomes

  1. Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mazandaran University of Medical Sciences

Other

Registry information

Acronym: EMISO

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 28, 2015
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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