To investigate the efficacy and safety of MCI-186 (bolus followed by continuous infusion) in acute ischemic stroke patients through a double-blind, parallel-group comparison with the existing MCI-186 dosing regimen (administration twice daily for 14 days) as the control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
intravenous injection
intravenous injection
intravenous injection
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved.
NIHSS is a scale to objectively quantify the neurologic impairment caused by a stroke. Possible scores range from 0 (no stroke symptoms) to 40(severe stroke).
Time frame: Baseline up to Day 7
Comparison of National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a scale used to objectively quantify the neurologic impairment caused by a stroke. Possible scores range from 0 (no stroke symptoms) to 40 (severe stroke).
Time frame: Day 14, at discharge(from Day15 to after 3 months) and after 3 months
Number of Participants With Modified Rankin Scale (mRS) 0-1 at Each Evaluations
mRS is a scale for measuring the degree of disability caused by a stroke. Possible scores range from Grade 0 (no symptoms) to Grade 6 (death). Number of Participants with Modified Rankin Scale (mRS) 0-1 are evaluated.
Time frame: at discharge(from Day15 to after 3 months) and after 3 months
Comparison of Barthel Index (BI)
BI is a scale for measuring performance in Activities of Daily Living (ADL). Possible scores range from 0 (worst) to 100 (best).
Time frame: at discharge(from Day15 to after 3 months) and after 3 months
Comparison of Functional Independence Measure (FIM)
FIM is a scale used to evaluate the functional status. Possible scores range from 18 (worst) to 126 (best).
Time frame: at discharge(from Day15 to after 3 months) and after 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
intravenous injection
intravenous injection
Investigational site 13
Aichi, Japan
Investigational site 39
Aomori, Japan
Investigational site 19
Chiba, Japan
Investigational site 28
Chiba, Japan
Investigational site 33
Ehime, Japan
Investigational site 10
Fukui, Japan
Investigational site 05
Fukuoka, Japan
Investigational site 09
Fukuoka, Japan
Investigational site 11
Fukuoka, Japan
Investigational site 12
Fukuoka, Japan
...and 35 more locations