Cerebrovascular AccidentPhase 2/3NCT00046761
A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
A Phase 2/3 study testing ONO-2506 in people with Cerebrovascular Accident, run by Ono Pharma USA Inc at 148 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- ONO-2506
- How many people
- 1,320 participants
- Where
- 148 sitesin 2 countries
- Study dates
- Nov 2002to May 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a)
- forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
148 sites in 2 countries.
148 sites in 2 countries
United States130 sites
Akron General Medical Center
Akron, Ohio, 44307
St. Peter's Hospital
Albany, New York, 12208
The Innovative Clincal Research Center
Alexandria, Virginia, 22304
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Alta Bates Hospital/ Summit Medical Center
Berkeley, California, 94705
MacNeal Hospital
Berwyn, Illinois, 60402
Brookwood Medical Center
Birmingham, Alabama, 35209
University of Alabama
Birmingham, Alabama, 35294
BroMenn Regional Medical Center
Bloomington, Illinois, 61704
OSF St. Joseph Medical Center
Bloomington, Illinois, 61704
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Buffalo General Hospital
Buffalo, New York, 14203
Millard Fillmore Hospital
Buffalo, New York, 14209
Cooper Hospital /University Medical Center
Camden, New Jersey, 08103
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Charleston Area Medical Center
Charleston, West Virginia, 25301
Erlanger Hospital
Chattanooga, Tennessee, 37403
Morton Plant Hospital
Clearwater, Florida, 33756
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Metrohealth Medical Center
Cleveland, Ohio, 44109
St. Francis Hospital
Columbus, Georgia, 31901
Baylor University Medical Center
Dallas, Texas, 75214
University of Texas; Southwestern Medical Center at Dallas
Dallas, Texas, 75390
DeKalb Medical Center
Decatur, Georgia, 30033
Gwinnett Medical Center
Decatur, Georgia, 30033
Joan Glancy Memorial Hospital
Decatur, Georgia, 30034
Mercy Hospital Medical Center
Des Moines, Iowa, 50314
Detroit Receiving Hospital/ Wayne State Univ
Detroit, Michigan, 48201
JFK Medical Center
Edison, New Jersey, 08818
Alexian Brothers Hospital
Elk Grove Village, Illinois, 60007
Elkhart General Hospital
Elkhart, Indiana, 46540
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
North Broward Medical Center
Fort Lauderdale, Florida, 33308
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804
Parkview Hospital
Fort Wayne, Indiana, 46805
Alachua General Hospital
Gainsville, Florida, 32605
Benefits Healthcare/ Advanced Neurology Specialists
Great Falls, Montana, 59405
Westmoreland Regional Hospital
Greensburg, Pennsylvania, 15601
Greenville Hospital
Greenville, South Carolina, 29615
The Stroke Center at Hartford Hospital
Hartford, Connecticut, 06106
Aventura Hospital and Medical Center
Hollywood, Florida, 33021
Queen's Medical Center
Honolulu, Hawaii, 96813
Methodist Hospital /Baylor College of Medicine
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
Wilson Memorial Regional Medical Center
Johnson City, New York, 13790
Borgess Research Institute
Kalamazoo, Michigan, 49048
University of Kansas Medical Center
Kansas City, Kansas, 66160
Kettering Medical Center -Wallace Kettering Neuroscience Inst.
Kettering, Ohio, 45429
Grossmont Hospital
La Mesa, California, 91942
Lexington Clinic
Lexington, Kentucky, 40504
Chandler Medical Center /Univ of Kentucky
Lexington, Kentucky, 40536
Loma Linda University Medical Center
Loma Linda, California, 92354
UCLA Medical Center
Los Angeles, California, 90024
University of Louisville Hospital
Louisville, Kentucky, 40202
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
Neurology Associates, PA
Maitland, Florida, 32751
North Shore University Hospital
Manhasset, New York, 11030
St. Joseph's Hospital/ Marshfield Clinic
Marshfield, Wisconsin, 54449
Virtua Memorial Hospital
Medford, New Jersey, 08055
Rogue Valley Medical Center
Medford, Oregon, 97504
Regional Medical Center at Memphis
Memphis, Tennessee, 38103
Baptist Hospital of Miami
Miami, Florida, 33156
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Winthrop University Hospital
Mineola, New York, 11501
Mount Vernon Hospital
Mount Vernon, New York, 10550
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Theda Clark Medical Center
Neenah, Wisconsin, 54956
Robert Wood Johnson Hospital
New Brunswick, New Jersey, 08901
Yale - New Haven Hospital
New Haven, Connecticut, 06520
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Mt. Sinai Hospital
New York, New York, 10029
Advocate Christ Hospital & Medical Center
Oak Lawn, Illinois, 60453
Ocala Regional Medical Center
Ocala, Florida, 34471
Munroe Regional Medical Center
Ocala, Florida, 34478
Creighton University Medical Center
Omaha, Nebraska, 68131
Stanford Stroke Center
Palo Alto, California, 94304
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
Muhlenberg Hospital
Plainfield, New Jersey, 07061
BonSecours - St. Joseph's Hospital
Port Charlotte, Florida, 33952
Charlotte Regional Medical Center
Port Charlotte, Florida, 33952
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952
Oregon Health and Science University - Oregon Stroke Center
Portland, Oregon, 97201
Providence Portland Medical Center
Portland, Oregon, 97213
Providence St. Vincent's Hospital
Portland, Oregon, 97225
Miriam Hospital
Providence, Rhode Island, 02906
Mercy Medical Center
Redding, California, 96001
Redding Medical Center
Redding, California, 96001
Washoe Medical Center
Reno, Nevada, 89502
Virginia Commonwealth University /Medical College of VA
Richmond, Virginia, 23219
Henrico Doctors Hospital
Richmond, Virginia, 23226
Memorial Regional Medical Center
Richmond, Virginia, 23226
St. Mary's Hospital
Richmond, Virginia, 23226
Valley Hospital
Ridgewood, New Jersey, 08629
Rochester General Hospital
Rochester, New York, 14621
Strong Memorial Hospital
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
UC Davis Medical Center
Sacramento, California, 95817
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
Rowan Regional Medical Center
Salisbury, North Carolina, 28144
University of Utah Medical Center
Salt Lake City, Utah, 84132
University Hospital /Univ of Texas Health Science Center
San Antonio, Texas, 78229
Good Samaritan Hospital
San Jose, California, 95124
Ellis Hospital Stroke Center B421
Schenectady, New York, 12308
Harborview Medical Center
Seattle, Washington, 98104
LSU Health Sciences Center
Shreveport, Louisiana, 71130
St. John's Hospital
Springfield, Illinois, 62702
Memorial Medical Center
Springfield, Illinois, 62781
St. John's Clinic - Smith-Glynn-Callaway
Springfield, Missouri, 65804
Bayfront Medical Center
St. Petersburg, Florida, 33701
Palms of Pasadina Hospital
St. Petersburg, Florida, 33707
SUNY Stony Brook University Hospital
Stony Brook, New York, 11794
Overlook Hospital
Summit, New Jersey, 07091
St. Joseph Hospital
Tampa, Florida, 33606
Tampa General Hospital
Tampa, Florida, 33606
Memorial Hospital of Tampa
Tampa, Florida, 33608
Medical College of Ohio Hospital
Toledo, Ohio, 43614
Community Medical Center
Toms River, New Jersey, 08755
St. Francis Medical Center
Trenton, New Jersey, 08629
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Crozer Chester Medical Center
Upland, Pennsylvania, 19013
Central DuPage Hospital
Warrenville, Illinois, 60555
Cleveland Clinic Florida
Weston, Florida, 33331
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
York Hospital
York, Pennsylvania, 17402
St. Elizabeth's Health Center
Youngstown, Ohio, 44501
Canada18 sites
Foothills Medical Center /University of Calgary
Calgary, Alberta, T2N 2T9
Complexe Hospitalier de La Sagamie
Chicoutimi, Quebec, G7H 5H6
University of Alberta Hospital /Mackenzie Center
Edmonton, Alberta, T6G 2B7
Centre Hospitalier des Vallees de l'Outaouais
Gatineau, Quebec, J8Y 1W7
Royal Inland Hospital
Kamloops, British Columbia, V2C 2T1
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Lethbridge Regional Hospital
Lethbridge, Alberta, T1O 1W5
Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1
London Health Sciences Centre
London, Ontario, N6A 5A5
Trillium Health Centre
Mississauga, Ontario, L5B 4A2
Hospital Notre Dame du Chum
Montreal, Quebec, H2L 4M1
York Central Hospital
Richmond Hill, Ontario, L4C 9M7
Hotel-Dieu de St-Jerome
Saint-Jérôme, Quebec, J7Z5T3
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
St Paul's Hospital
Vancouver, British Columbia, U6Z 2A5
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Royal Jubilee Hospital
Victoria, British Columbia, V8R 4R2
About this study
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.
- Conditions
- Cerebrovascular Accident
- Being tested
- ONO-2506
- Keywords
- Acute Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-2506Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2002 (estimated)
- Study startNov 2002
- Primary completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,320 participants
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Due, Ph.D., Study director, Ono Pharma USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046761
- Sponsor's protocol ID
- 2506/INT0104
- Status last verified
- Oct 2012
- First submitted
- 2 Oct 2002
- Last updated
- 11 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00046761
- Acronym / sponsor ID
- 2506/INT0104
- Conditions
- Cerebrovascular Accident
- Keywords
- Acute Ischemic Stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,320 participants
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- May 2005 (actual)
- First posted
- 4 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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:
- Patient must not have neurological signs and symptoms that are rapidly improving.
- Patient must not have a severe coexisting or terminal systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-2506 | Drug | – |
Primary outcome
Modified Rankin Scale
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
Related trials for Cerebrovascular Accident
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Due, Ph.D. study director
Ono Pharma USA Inc
148 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ONO-2506 in people with Cerebrovascular Accident, run by Ono Pharma USA Inc at 148 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 148 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.