Acute Ischemic StrokePhase 2NCT00044057
A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)
A Phase 2 study testing YM872 (zonampanel), t-PA (alteplase) in people with Acute Ischemic Stroke, run by Astellas Pharma Inc at 118 sites in 5 countries.
Trial summary
The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- YM872 (zonampanel), t-PA (alteplase)
- How many people
- Not given
- Where
- 118 sitesin 5 countries
- Study dates
- Dec 2000to Jan 2003
- Phase
- Phase 2
- 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
- Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
- Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
- Patients who are at least 18 years of age.
- Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
- Other criteria as specified in the study protocol
Who cannot join
- Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.
- Patients who have stroke of the brainstem or cerebellum.
- Patients who have renal (kidney) disease or insufficiency.
- Patients who have active epilepsy or convulsions during the current stroke episode.
- Patients who are IV drug users or are inebriated.
- Patients who have a history of drug-related anaphylaxis.
Show all 10Show fewer
- Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
- Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
- Patients who have a known vitamin hypersensitivity.
- Other exclusion criteria as specified by the study protocol
Trial locations and contacts
118 sites in 5 countries.
118 sites in 5 countries
United States94 sites
Akron General Medical Center
Akron, Ohio
Albany Medical Center
Albany, New York
University of New Mexico Hospital
Albuquerque, New Mexico
VA Medical Center
Albuquerque, New Mexico
Lehigh Valley Hospital
Allentown, Pennsylvania
Columbia JFK Hospital
Atlantis, Florida
University of Maryland Medical System
Baltimore, Maryland
Neurological Research Center, Inc
Bennington, Vermont
East Bay Region Associates in Neurology
Berkeley, California
Beth Israel Deaconess Medical Center
Boston, Massachusetts
New England Medical Center
Boston, Massachusetts
Bethesda Memorial Hospital
Boynton Beach, Florida
Bridgeport Hospital
Bridgeport, Connecticut
Buffalo General Hospital
Buffalo, New York
Providence St. Joseph's Medical Center
Burbank, California
Mercy San Juan Hospital
Carmichael, California
Roper Hospital
Charleston, South Carolina
Chattanooga Neurology Associates (Erlanger Hospital)
Chattanooga, Tennessee
Chattanooga Neurology Associates (Memorial Hospital)
Chattanooga, Tennessee
Metrohealth Medical Center
Cleveland, Ohio
St Francis Hospital
Columbus, Georgia
Riverside Methodist Hospital
Columbus, Ohio
Geisinger Medical Center
Danville, Pennsylvania
University of California Davis Medical Center
Davis, California
DNA Research (Dekalb Medical Center)
Decatur, Georgia
St John's Hospital
Detroit, Michigan
Michigan State University
East Lansing, Michigan
JFK Medical Center
Edison, New Jersey
Stevens Memorial Hospital
Edmonds, Washington
Scripps Memorial Hospital
Encinitas, California
Colorado Neurological Institute
Englewood, Colorado
Parkview Hospital
Fort Wayne, Indiana
Advanced Neurology Specialists (Benefis Healthcare Hospital)
Great Falls, Montana
Westmoreland Regional Hospital
Greensburg, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania
Queen's Medical Center
Honolulu, Hawaii
University of Texas (Houston Medical Center)
Houston, Texas
Methodist Hospital
Indianapolis, Indiana
Research Medical Center
Kansas City, Missouri
Grossmont Hospital
La Mesa, California
Lakeland Regional Medical Center
Lakeland, Florida
UCLA Medical Center
Los Angeles, California
Louisville Neuroscience Research Center
Louisville, Kentucky
North Shore University Hospital
Manhasset, New York
Culicchia Neurology Clinic, LLP
Marrero, Louisiana
Holmes Regional Medical Center
Melbourne, Florida
St. Luke's Medical Center
Milwaukee, Wisconsin
University of South Alabama Stroke Center
Mobile, Alabama
St. Thomas Hospital
Nashville, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee
Theda Clark Medical Center
Neenah, Wisconsin
Long Island Jewish Medical Center
New Hyde Park, New York
Columbia Presbyterian Medical Center
New York, New York
Roosevelt Hospital
New York, New York
St. Luke's Hospital
New York, New York
Tri-City Medical Center
Oceanside, California
Providence St. Peter Hospital
Olympia, Washington
Stanford University Medical Center
Palo Alto, California
Bay Medical Center
Panama City, Florida
OSF St. Francis Medical Center
Peoria, Illinois
Albert Einstein Medical Center
Philadelphia, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania
Good Samaritan Hospital
Phoenix, Arizona
University of Pittsburgh Medical Center Stroke Institute
Pittsburgh, Pennsylvania
Muhlenberg Regional Medical Center
Plainfield, New Jersey
Miriam Hospital
Providence, Rhode Island
Washoe Comprehensive Stroke Center
Reno, Nevada
Neurology Associates, Inc. (St. Mary's Hospital)
Richmond, Virginia
Neurology Group of Bergen County (Valley Hospital)
Ridgewood, New Jersey
Rochester General Hospital
Rochester, New York
William Beaumont Hospital
Royal Oak, Michigan
Mercy General Hospital
Sacramento, California
Scripps Mercy Hospital
San Diego, California
University of California at San Diego
San Diego, California
Good Samaritan Hospital
San Jose, California
UCLA Medical Center - Santa Monica
Santa Monica, California
Candler Hospital
Savannah, Georgia
St Joseph Hospital
Savannah, Georgia
Ellis Hospital
Schenectady, New York
Stony Brook Hospital
Stony Brook, New York
St Joseph's Hospital
Tampa, Florida
Tampa General Hospital
Tampa, Florida
Medical College of Ohio
Toledo, Ohio
Northern Michigan Neurology
Traverse City, Michigan
University of Arizona
Tucson, Arizona
Crozer Chester Medical Center
Upland, Pennsylvania
Virginia Beach General Hospital
Virginia Beach, Virginia
John Muir Medical Center
Walnut Creek, California
Mt Diablo Medical Center
Walnut Creek, California
Bi-County Hospital
Warren, Michigan
Forsyth Medical Center
Winston-Salem, North Carolina
Rowan Regional Medical Center
Winston-Salem, North Carolina
St. Elizabeth Health Center
Youngstown, Ohio
Germany12 sites
Universitätsklinikum Aachen, Neurologische Klinik
Aachen
Universität zu Köln klinik und poliklinik fur neurology
Cologne
University Essen
Essen
Neurologische Universitätsklinik
Freiburg im Breisgau
Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
Hamburg-Eppendorf
Neurology Klinik Klinikum Hanover
Hanover
Friedrich-Schiller-University
Jena
Universitätsklinikum Leipzig
Leipzig
Universitätsklinik Mainz
Mainz
Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
München
Neurologische Klinik Knappschafts - krankenhause
Recklinghausen
Neurologisch Psychiayrische Klinik
Weisbaden
Canada10 sites
Foothills Medical Centre
Calgary, Alberta
University of Alberta Hospital
Edmonton, Alberta
Charles LeMoyne Hospital
Greenfield Park, Quebec
Notre-Dame Hospital
Montreal, Quebec
Penticton Regional Hospital
Penticton, British Columbia
Royal University Hospital
Saskatoon, Saskatchewan
Pavillion St Joseph
Trois Rivers, Quebec
Vancouver General Hospital
Vancouver, British Columbia
Royal Jubilee Hospital
Victoria, British Columbia
Victoria General Hospital
Victoria, British Columbia
Austria1 site
Universitätsklinik allgemeines Krankenhaus der Stadt Wien
Vienna
About this study
Official title: A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo
The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.
- Conditions
- Acute Ischemic Stroke
- Being tested
- YM872 (zonampanel), t-PA (alteplase)
- Keywords
- ARTIST
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM872 (zonampanel), t-PA (alteplase)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2002 (estimated)
- Study startDec 2000
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044057
- Sponsor's protocol ID
- 872-CL-004
- Status last verified
- Mar 2006
- First submitted
- 16 Aug 2002
- Last updated
- 3 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo
- ClinicalTrials.gov ID
- NCT00044057
- Acronym / sponsor ID
- 872-CL-004
- Conditions
- Acute Ischemic Stroke
- Keywords
- ARTIST
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Dec 2000
- Study completion
- Jan 2003
- First posted
- 20 Aug 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 purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- 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 (5 listed)
- Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
- Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
- Patients who are at least 18 years of age.
- Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
- Other criteria as specified in the study protocol
Key exclusion criteria (10 listed)
- Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.
- Patients who have stroke of the brainstem or cerebellum.
- Patients who have renal (kidney) disease or insufficiency.
- Patients who have active epilepsy or convulsions during the current stroke episode.
- Patients who are IV drug users or are inebriated.
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 |
|---|---|---|
| YM872 (zonampanel), t-PA (alteplase) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
118 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM872 (zonampanel), t-PA (alteplase) in people with Acute Ischemic Stroke, run by Astellas Pharma Inc at 118 sites in 5 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 3 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 118 sites in United States, Germany, Canada, Austria, Belgium. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 3 Apr 2006.