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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT00046761
First received: October 2, 2002
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Drug: ONO-2506
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Modified Rankin Scale

Estimated Enrollment: 1320
Study Start Date: November 2002
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046761

  Show 148 Study Locations
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Bryan Due, Ph.D. Ono Pharma USA Inc
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT00046761     History of Changes
Other Study ID Numbers: 2506/INT0104
Study First Received: October 2, 2002
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharmaceutical Co. Ltd:
Acute Ischemic Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014