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

Stopped early · Phase 2/Phase 3

Conditions studied: Cerebrovascular Accident

In brief

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.

Key facts

Study ID

NCT00046761

Run by

Ono Pharma USA Inc

People needed

1320

Starts

2002-11-01

Last updated by the study team

2012-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Alta Bates Hospital/ Summit Medical Center — Berkeley, California, United States
• Grossmont Hospital — La Mesa, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Stanford Stroke Center — Palo Alto, California, United States
• Mercy Medical Center — Redding, California, United States
• Redding Medical Center — Redding, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Good Samaritan Hospital — San Jose, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• The Stroke Center at Hartford Hospital — Hartford, Connecticut, United States
• Yale - New Haven Hospital — New Haven, Connecticut, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• North Broward Medical Center — Fort Lauderdale, Florida, United States
• Alachua General Hospital — Gainsville, Florida, United States
• Aventura Hospital and Medical Center — Hollywood, Florida, United States
• Neurology Associates, PA — Maitland, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Ocala Regional Medical Center — Ocala, Florida, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• BonSecours - St. Joseph's Hospital — Port Charlotte, Florida, United States
• Charlotte Regional Medical Center — Port Charlotte, Florida, United States
• Fawcett Memorial Hospital — Port Charlotte, Florida, United States
• Brookwood Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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