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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
History of Changes
  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
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 May 19, 2013