Clinical trial NCT00046761: A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
Official title: A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Cerebrovascular Accident
Keywords: Acute Ischemic Stroke
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2002-10-04
Enrollment: 1320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Modified Rankin Scale
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brookwood Medical Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Berkeley
country: United States
facility: Alta Bates Hospital/ Summit Medical Center
state: California
city: La Mesa
country: United States
facility: Grossmont Hospital
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Stroke Center
state: California
city: Redding
country: United States
facility: Mercy Medical Center
state: California
city: Redding
country: United States
facility: Redding Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Hartford
country: United States
facility: The Stroke Center at Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale - New Haven Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Ft. Lauderdale
country: United States
facility: North Broward Medical Center
state: Florida
city: Gainsville
country: United States
facility: Alachua General Hospital
state: Florida
city: Hollywood
country: United States
facility: Aventura Hospital and Medical Center
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, PA
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Ocala
country: United States
facility: Ocala Regional Medical Center
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Port Charlotte
country: United States
facility: BonSecours - St. Joseph's Hospital
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Regional Medical Center
state: Florida
city: Port Charlotte
country: United States
facility: Fawcett Memorial Hospital
state: Florida
city: St. Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: St. Petersburg
country: United States
facility: Palms of Pasadina Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Memorial Hospital of Tampa
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Columbus
country: United States
facility: St. Francis Hospital
state: Georgia
city: Decatur
country: United States
facility: DeKalb Medical Center
state: Georgia
city: Decatur
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Decatur
country: United States
facility: Joan Glancy Memorial Hospital
state: Georgia
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Berwyn
country: United States
facility: MacNeal Hospital
state: Illinois
city: Bloomington
country: United States
facility: BroMenn Regional Medical Center
state: Illinois
city: Bloomington
country: United States
facility: OSF St. Joseph Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Hospital & Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Warrenville
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Lutheran Hospital of Indiana
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Lexington Clinic
state: Kentucky
city: Lexington
country: United States
facility: Chandler Medical Center /Univ of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Receiving Hospital/ Wayne State Univ
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: St. Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Springfield
country: United States
facility: St. John's Clinic - Smith-Glynn-Callaway
state: Missouri
city: Great Falls
country: United States
facility: Benefits Healthcare/ Advanced Neurology Specialists
state: Montana
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Reno
country: United States
facility: Washoe Medical Center
state: Nevada
city: Camden
country: United States
facility: Cooper Hospital /University Medical Center
state: New Jersey
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Medford
country: United States
facility: Virtua Memorial Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson Hospital
state: New Jersey
city: Plainfield
country: United States
facility: Muhlenberg Hospital
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Albany
country: United States
facility: St. Peter's Hospital
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: Buffalo
country: United States
facility: Millard Fillmore Hospital
state: New York
city: Johnson City
country: United States
facility: Wilson Memorial Regional Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Mount Vernon
country: United States
facility: Mount Vernon Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Schenectady
country: United States
facility: Ellis Hospital Stroke Center B421
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook University Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Salisbury
country: United States
facility: Rowan Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center -Wallace Kettering Neuroscience Inst.
state: Ohio
city: Toledo
country: United States
facility: Medical College of Ohio Hospital
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth's Health Center
state: Ohio
city: Medford
country: United States
facility: Rogue Valley Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University - Oregon Stroke Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent's Hospital
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Greensburg
country: United States
facility: Westmoreland Regional Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburg
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
city: Upland
country: United States
facility: Crozer Chester Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Hospital
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Hospital
state: Tennessee
city: Memphis
country: United States
facility: Regional Medical Center at Memphis
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas; Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Methodist Hospital /Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: University Hospital /Univ of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
city: Alexandria
country: United States
facility: The Innovative Clincal Research Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University /Medical College of VA
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors Hospital
state: Virginia
city: Richmond
country: United States
facility: Memorial Regional Medical Center
state: Virginia
city: Richmond
country: United States
facility: St. Mary's Hospital
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospitals and Clinics
state: Wisconsin
city: Marshfield
country: United States
facility: St. Joseph's Hospital/ Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Neenah
country: United States
facility: Theda Clark Medical Center
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Medical Center /University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital /Mackenzie Center
state: Alberta
city: Lethbridge
country: Canada
facility: Lethbridge Regional Hospital
state: Alberta
city: Kamloops
country: Canada
facility: Royal Inland Hospital
state: British Columbia
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Richmond Hill
country: Canada
facility: York Central Hospital
state: Ontario
city: Chicoutimi
country: Canada
facility: Complexe Hospitalier de La Sagamie
state: Quebec
city: Gatineau
country: Canada
facility: Centre Hospitalier des Vallees de l'Outaouais
state: Quebec
city: Levis
country: Canada
facility: Hotel-Dieu de Levis
state: Quebec
city: Montreal
country: Canada
facility: Hospital Notre Dame du Chum
state: Quebec
city: Saint-Jerome
country: Canada
facility: Hotel-Dieu de St-Jerome
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: Ono Pharma USA Inc
name: Bryan Due, Ph.D.
role: STUDY_DIRECTOR
References: