Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

Phase 3

Completed

• Conditions: Ischemic Stroke; Memantine; Excitotoxicity
• Interventions: Drug: Placebo; Drug: Memantine

• Registration Number: NCT02535611
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-22
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-28
• Study Start: 2015-10
• Primary Completion: 2016-10
• Study Completion: 2017-09
• Results First Submitted: 2020-08-11
• Results First Submitted QC: 2020-08-27
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Results First Posted: 2020-09-16
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Memantine	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.

Primary Outcome Measures

Name	Time	Method
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.; 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.; 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.