A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy of ONO-2506 versus placebo in neurological stroke outcome in patients with acute ischemic stroke.

Official Title
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A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Drug: ONO-2506


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have a clinical diagnosis of acute cortical ischemic stroke. Patient must be randomized into the study within six hours after the initial onset of stroke symptoms. Patient must have a measurable focal neurological deficit for a minimum duration of 60 minutes. Patient must have a CT or MRI examination compatible with the clinical diagnosis of acute ischemic stroke. Patient must have had a pre-stroke mRS scale score of 0 or 1. Other inclusion criteria as specified in the study protocol. Exclusion Criteria: Patient must not have a body weight of more than 125 kg. Patient must not have a CT and/or MRI with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, or primary intracerebral and/or intraventricular hemorrhage. Patient must not have all three of the following findings: reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a) forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and dense hemiplegia (no movement) of upper and lower extremities (i.e., has score of 4 on NIHSS Question 5 regarding motor arm and has score of 4 on NIHSS Question 6 regarding motor leg). Patient must not have neurological signs and symptoms that are rapidly improving. Patient must not have a severe coexisting or terminal systemic disease. Patient must not be pregnant or lactating. Patient must not have impaired hepatic function; bilirubin greater than 2 mg/dL and or ascites. Patient must not have impaired renal function; serum creatinine greater than 2 mg/dL. Patient must not have congestive heart failure. Patient must not have a baseline ECG showing a PR interval greater than 200 milliseconds, or a corrected QT interval of greater than 480 milliseconds, or a history of ventricular arrhythmias, or a Mobitz Type 1 or greater AV block. Patient must not have other exclusion criteria as specified in the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ONO-2506|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke