Study of ONO-2506 in Patients With Acute Ischemic Stroke
Phase 2
Completed
- Conditions
- Stroke
- Interventions
- Drug: ONO-2506
- Registration Number
- NCT00229177
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 757
Inclusion Criteria
- Subjects who have a clinical diagnosis of acute ischemic stroke
- Subjects within 72 hours after onset of the stroke
- Other inclusion criteria may apply.
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Exclusion Criteria
- Subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction)
- Subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant.
- Other exclusion criteria may apply.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P ONO-2506 - E2 ONO-2506 - E1 ONO-2506 -
- Primary Outcome Measures
Name Time Method Modified Rankin Scale at 90 days 90 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (9)
Kinki Region Facility
🇯🇵Kinki, Japan
Chubu Region Facility
🇯🇵Chubu, Japan
Chugoku Region Facility
🇯🇵Chugoku, Japan
Hokuriku Region Facility
🇯🇵Hokuriku, Japan
Hokkaido Region Facility
🇯🇵Hokkaido, Japan
Kyushu Region Facility
🇯🇵Kyushu, Japan
Kanto Region Facility
🇯🇵Kanto, Japan
Shikoku Region Facility
🇯🇵Shikoku, Japan
Tohoku Region Facility
🇯🇵Tohuku, Japan