Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

NCT ID: NCT02535611

Last Updated: 2020-10-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-09-30

Brief Summary

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

Detailed Description

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Conditions

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Ischemic Stroke Excitotoxicity Memantine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Memantine

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Memantine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mazandaran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Nasim Tabrizi

Assistant professor of neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MAZUMS

Identifier Type: -

Identifier Source: org_study_id

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