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

September 15, 2020 updated by: Nasim Tabrizi, Mazandaran University of Medical Sciences
The researchers aim to investigate the effect of memantine on stroke outcome in a randomized double-blind placebo-controlled clinical trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
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.

  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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days
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.

  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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mazandaran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

August 22, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAZUMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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