Cerebrovascular AccidentPhase 2NCT00044070
A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
A Phase 2 study testing YM872 (zonampanel) in people with Cerebrovascular Accident, run by Astellas Pharma Inc at 89 sites in 6 countries.
Trial summary
This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. 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?
- YM872 (zonampanel)
- How many people
- Not given
- Where
- 89 sitesin 6 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 who have suffered an acute ischemic stroke and can be evaluated and treatment initiated within 6 hours after the onset of symptoms (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 have a three dimensionally measurable lesion compatible with an acute ischemic stroke measured using MRI.
- 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.
- 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.
- Other criteria as specified in the study protocol
Who cannot join
- Patients who have received alteplase (t-PA) for the current stroke episode. It is assumed that all patients who are eligible will receive treatment with t-PA.
- Patients who have disability and functional limitations prior to the current stroke episode (e.g. deficit resulting from a prior stroke).
- Patients who have brain hemorrhage.
- Patients who have stroke of the brainstem or cerebellum.
- Patients who cannot be evaluated using MRI due to the presence of a pacemaker, claustrophobia, need for sedation, etc.
- Patients who have renal (kidney) disease or insufficiency.
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- 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.
- 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
89 sites in 6 countries.
89 sites in 6 countries
United States60 sites
Albany Medical Center
Albany, New York
University of New Mexico Hospital
Albuquerque, New Mexico
VA Medical Center
Albuquerque, New Mexico
Johns Hopkins Medical Institute
Baltimore, Maryland
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
Chattanooga Neurology Associates (Erlanger Hospital)
Chattanooga, Tennessee
Chattanooga Neurology Associates (Memorial Hospital)
Chattanooga, Tennessee
Metrohealth Medical Center
Cleveland, Ohio
Riverside Methodist Hospital
Columbus, Ohio
DNA Research (Dekalb Medical Center)
Decatur, Georgia
Wayne State University
Detroit, Michigan
Michigan State University
East Lansing, Michigan
JFK Medical Center
Edison, New Jersey
Stevens Memorial Hospital
Edmonds, Washington
Parkview Hospital
Fort Wayne, Indiana
Advanced Neurology Specialists (Benefis Healthcare Hospital)
Great Falls, Montana
Hershey Medical Center
Hershey, Pennsylvania
University of Texas (Houston Medical Center)
Houston, Texas
Grossmont Hospital
La Mesa, California
University of Kentucky
Lexington, Kentucky
UCLA Emergency Medical Center
Los Angeles, California
Louisville Neuroscience Research Center
Louisville, Kentucky
North Shore University Hospital
Manhasset, New York
Cullicchia Neurology Clinic, LLP
Marrero, Louisiana
Holmes Regional Medical Center
Melbourne, Florida
University of Miami (Jackson Memorial Hospital)
Miami, Florida
St. Luke's Medical Center
Milwaukee, Wisconsin
St. Patrick's Hospital & Health Sciences Center
Missoula, Montana
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
St. Luke's Hospital
New York, New York
Providence St. Peter Hospital
Olympia, Washington
OSF St. Francis Medical Center
Peoria, Illinois
Phoenix Neurology Associates (Good Samaritan Hospital)
Phoenix, Arizona
University of Pittsburgh Medical Center Stroke Institute
Pittsburgh, Pennsylvania
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
William Beaumont Hospital
Royal Oak, Michigan
Field Neurosciences Institute (St. Mary's Hospital)
Saginaw, Michigan
Good Samaritan Hospital
San Jose, California
Santa Monica UCLA Medical Center
Santa Monica, California
Ellis Hospital
Schenectady, New York
Sacred Heart Medical Center
Spokane, Washington
Stony Brook Hospital
Stony Brook, New York
Florida Neurovascular Institute
Tampa, Florida
Medical College of Ohio
Toledo, Ohio
University of Arizona
Tucson, Arizona
Virginia Beach General Hospital
Virginia Beach, Virginia
John Muir Medical Center
Walnut Creek, California
All-Trials Clinical Research, LLC (Rowan Regional Medical Center)
Winston-Salem, North Carolina
St. Elizabeth Health Center
Youngstown, Ohio
Germany13 sites
Universitätsklinikum Aachen, Neurologische Klinik
Aachen
Universität zu Köln klinik und poliklinik fur neurology
Cologne
University of Essen
Essen
Neurologische Universitätsklinik, Albert-Ludwigs-University
Freiburg im Breisgau
Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
Hamburg-Eppendorf
Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
Homburg Saar
Friedrich-Schiller-University
Jena
Universitatklinikum Leipzig
Leipzig
Universitätsklinik Mainz
Mainz
Department of Neurology Klinikum
Minden
Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
München
Neurologische Klinik Knappschafts - krankenhause
Recklinghausen
Dr.-H.-Schmidt-Kliniken Ludwig-Erhar
Wiesbaden
South Africa9 sites
Muelmed Hospital
Arcadia
Bloemfontein Medi-Clinic
Bloemfontein
Groote Schuur Hospital
Cape Town
St. Augustine's Hospital
Durban
Sandton Medi-Clinic
Johannesburg
Pietermaritzburg Medi-Clinic
Pietermaritzburg
Little Company of Mary Medical Centre
Pretoria
Vergelegen Medi-Clinic
Somerset West
Sunninghill Hospital
Sunninghill
Belgium3 sites
Hopital Erasme
Brussels
Service de Neurologie, Cliniques Universitaires St.-Luc
Brussels
Dienst Neurologie UZ Gasthuisberg
Leuven
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta
Toronto Western Hospital
Toronto, Ontario
Royal Jubilee Hospital
Victoria, British Columbia
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Effects of YM872 on Lesion Volume as Measured by Diffusion, Perfusion, and FLAIR Magnetic Resonance Imaging in Patients With Acute Ischemic Stroke
This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be determined by neurological function and disability scores at follow up visits through Day 90 of the study.
- Conditions
- Cerebrovascular Accident
- Being tested
- YM872 (zonampanel)
- Keywords
- ARTIST, 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.
YM872 (zonampanel)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 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
- 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
- NCT00044070
- Sponsor's protocol ID
- 872-CL-003
- 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 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Effects of YM872 on Lesion Volume as Measured by Diffusion, Perfusion, and FLAIR Magnetic Resonance Imaging in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00044070
- Acronym / sponsor ID
- 872-CL-003
- Conditions
- Cerebrovascular Accident
- Keywords
- ARTIST, Acute ischemic stroke
- 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.
This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be determined by 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 (6 listed)
- Patients who have suffered an acute ischemic stroke and can be evaluated and treatment initiated within 6 hours after the onset of symptoms (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 have a three dimensionally measurable lesion compatible with an acute ischemic stroke measured using MRI.
- 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.
- 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.
Key exclusion criteria (13 listed)
- Patients who have received alteplase (t-PA) for the current stroke episode. It is assumed that all patients who are eligible will receive treatment with t-PA.
- Patients who have disability and functional limitations prior to the current stroke episode (e.g. deficit resulting from a prior stroke).
- Patients who have brain hemorrhage.
- Patients who have stroke of the brainstem or cerebellum.
- Patients who cannot be evaluated using MRI due to the presence of a pacemaker, claustrophobia, need for sedation, etc.
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) | 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.
89 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM872 (zonampanel) in people with Cerebrovascular Accident, run by Astellas Pharma Inc at 89 sites in 6 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 13 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 89 sites in United States, Germany, South Africa, Belgium, Canada and 1 more country. 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.