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

Tracking Information

First Received Date ^ICMJE

October 2, 2002

Last Updated Date

May 5, 2006

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Modified Rankin Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00046761 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cerebrovascular Accident

Intervention ^ICMJE

Drug: ONO-2506

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

1320

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00046761

Responsible Party

Study ID Numbers ^ICMJE

2506/INT0104

Study Sponsor ^ICMJE

Ono Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bryan Due, Ph.D.

Ono Pharma

Information Provided By

Ono Pharma

Verification Date

May 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP