Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

NCT02535611 | Completed Phase 3 Results DMC

• 1 other identifier: MAZUMS
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ischemic Stroke; Excitotoxicity; Memantine

Outcome Measures

Primary Outcomes (2)

• 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

• 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. 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 Outcomes (2)

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

  28 days

• Investigation of Disability by Modified Rankin Scale (mRS)

  28 days

Study Arms (2)

Memantine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Placebo DRUG

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

Placebo

Memantine DRUG

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

Memantine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presentation at first 24hrs of disease onset
• Confirmation of ischemic stroke in MCA territory by imaging.
• Accepted consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Memantine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Nasim Tabrizi
• Organization: Mazandaran University of medical sciences

nasimtabrizi@gmail.com

+981133343015

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of neurology

Study Record Dates

• First Submitted: August 22, 2015
• First Posted: August 28, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 6, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09