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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ono Pharma USA Inc

Criteria

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:

1. reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a)

2. forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and

3. 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.