Conditions: Acute Ischemic Stroke
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: High-dose MCI-186 will be administered as a bolus, and then as a continuous infusion. In addition, a placebo will be administered as an intravenous infusion twice a day over 30 minutes. arm 2: Low-dose MCI-186 will be administered as a bolus, and then as a continuous infusion. In addition, a placebo will be administered as an intravenous infusion twice a day over 30 minutes. arm 3: A placebo will be administered as a bolus, and then as a continuous infusion. In addition, MCI-186 30 mg will be administered as an intravenous infusion twice a day over 30 minutes.

Interventions: intervention 1: Continuous infusion high-dose MCI-186 intervention 2: Continuous infusion low-dose MCI-186 intervention 3: Continuous infusion placebo intervention 4: Approved dosing regimen MCI-186 intervention 5: Approved dosing regimen placebo
Intervention descriptions: intervention 1: intravenous injection intervention 2: intravenous injection intervention 3: intravenous injection intervention 4: intravenous injection intervention 5: intravenous injection

Protocol document:
Prot_000.pdf: 

















































































































































SAP_001.pdf: