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

Phase 2

Terminated

• Conditions: Cerebrovascular Accident

• Registration Number: NCT00046761
• Lead Sponsor: Ono Pharma USA Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-10-02
• Study First Submitted QC: 2002-10-03
• Study First Posted: 2002-10-04
• Study Start: 2002-11
• Primary Completion: 2005-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale

Trial Locations

Locations (148)

Brookwood Medical Center; 🇺🇸 Birmingham, Alabama, United States

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

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