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

Ono Pharmaceuticals

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Cerebrovascular Accident

Treatments

Drug: ONO-2506

Study type

Interventional

Funder types

Industry

Identifiers

NCT00046761

2506/INT0104

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.