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

Mazandaran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Ischemic Stroke; Excitotoxicity; Memantine

Treatments: Drug: Memantine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02535611

MAZUMS

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups, including a placebo group

Memantine

Active Comparator group

Description:

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.

Treatment:

Drug: Memantine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo