Stroke
Conditions
Keywords
ONO-2506, stroke, Acute ischemic stroke
Brief summary
The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.
Interventions
DRUGONO-2506
Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who have a clinical diagnosis of acute ischemic stroke 2. Subjects within 72 hours after onset of the stroke 3. Other inclusion criteria may apply.
Exclusion criteria
1. Subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction) 2. Subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant. 3. Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale at 90 days | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale at 30 days | 30 days |
| National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days | 90 days |
Countries
Japan
Outcome results
None listed