A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044057
• Other study ID #: 872-CL-004
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2002
• Last updated: March 31, 2006
• Start date: December 2000
• Est. completion date: January 2003

Study information

• Verified date: March 2006
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke

Intervention

Drug:
• YM872 (zonampanel), t-PA (alteplase)

Locations

Country	Name	City	State
Austria	Universitätsklinik allgemeines Krankenhaus der Stadt Wien	Wien
Belgium	Dienst Neurologie UZ Gasthuisberg	Leuven
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Charles LeMoyne Hospital	Greenfield Park	Quebec
Canada	Notre-Dame Hospital	Montreal	Quebec
Canada	Penticton Regional Hospital	Penticton	British Columbia
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Pavillion St Joseph	Trois Rivers	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Royal Jubilee Hospital	Victoria	British Columbia
Canada	Victoria General Hospital	Victoria	British Columbia
Germany	Universitätsklinikum Aachen, Neurologische Klinik	Aachen
Germany	University Essen	Essen
Germany	Neurologische Universitätsklinik	Freiburg
Germany	Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie	Hamburg-Eppendorf
Germany	Neurology Klinik Klinikum Hanover	Hanover
Germany	Friedrich-Schiller-University	Jena
Germany	Universität zu Köln klinik und poliklinik fur neurology	Köln
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinik Mainz	Mainz
Germany	Neurologische Klinik Klinikum Rechts der Isar der TU Munchen	Munchen
Germany	Neurologische Klinik Knappschafts - krankenhause	Recklinghausen
Germany	Neurologisch Psychiayrische Klinik	Weisbaden
United States	Akron General Medical Center	Akron	Ohio
United States	Albany Medical Center	Albany	New York
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	VA Medical Center	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Columbia JFK Hospital	Atlantis	Florida
United States	University of Maryland Medical System	Baltimore	Maryland
United States	Neurological Research Center, Inc	Bennington	Vermont
United States	East Bay Region Associates in Neurology	Berkeley	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	New England Medical Center	Boston	Massachusetts
United States	Bethesda Memorial Hospital	Boynton Beach	Florida
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Buffalo General Hospital	Buffalo	New York
United States	Providence St. Joseph's Medical Center	Burbank	California
United States	Mercy San Juan Hospital	Carmichael	California
United States	Roper Hospital	Charleston	South Carolina
United States	Chattanooga Neurology Associates (Erlanger Hospital)	Chattanooga	Tennessee
United States	Chattanooga Neurology Associates (Memorial Hospital)	Chattanooga	Tennessee
United States	Metrohealth Medical Center	Cleveland	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	St Francis Hospital	Columbus	Georgia
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	University of California Davis Medical Center	Davis	California
United States	DNA Research (Dekalb Medical Center)	Decatur	Georgia
United States	St John's Hospital	Detroit	Michigan
United States	Michigan State University	East Lansing	Michigan
United States	JFK Medical Center	Edison	New Jersey
United States	Stevens Memorial Hospital	Edmonds	Washington
United States	Scripps Memorial Hospital	Encinitas	California
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Parkview Hospital	Fort Wayne	Indiana
United States	Advanced Neurology Specialists (Benefis Healthcare Hospital)	Great Falls	Montana
United States	Westmoreland Regional Hospital	Greensburg	Pennsylvania
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Queen's Medical Center	Honolulu	Hawaii
United States	University of Texas (Houston Medical Center)	Houston	Texas
United States	Methodist Hospital	Indianapolis	Indiana
United States	Research Medical Center	Kansas City	Missouri
United States	Grossmont Hospital	La Mesa	California
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	UCLA Medical Center	Los Angeles	California
United States	Louisville Neuroscience Research Center	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Culicchia Neurology Clinic, LLP	Marrero	Louisiana
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	University of South Alabama Stroke Center	Mobile	Alabama
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Theda Clark Medical Center	Neenah	Wisconsin
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Roosevelt Hospital	New York	New York
United States	St. Luke's Hospital	New York	New York
United States	Tri-City Medical Center	Oceanside	California
United States	Providence St. Peter Hospital	Olympia	Washington
United States	Stanford University Medical Center	Palo Alto	California
United States	Bay Medical Center	Panama City	Florida
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Good Samaritan Hospital	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Stroke Institute	Pittsburgh	Pennsylvania
United States	Muhlenberg Regional Medical Center	Plainfield	New Jersey
United States	Miriam Hospital	Providence	Rhode Island
United States	Washoe Comprehensive Stroke Center	Reno	Nevada
United States	Neurology Associates, Inc. (St. Mary's Hospital)	Richmond	Virginia
United States	Neurology Group of Bergen County (Valley Hospital)	Ridgewood	New Jersey
United States	Rochester General Hospital	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Scripps Mercy Hospital	San Diego	California
United States	University of California at San Diego	San Diego	California
United States	Good Samaritan Hospital	San Jose	California
United States	UCLA Medical Center - Santa Monica	Santa Monica	California
United States	Candler Hospital	Savannah	Georgia
United States	St Joseph Hospital	Savannah	Georgia
United States	Ellis Hospital	Schenectady	New York
United States	Stony Brook Hospital	Stony Brook	New York
United States	St Joseph's Hospital	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Medical College of Ohio	Toledo	Ohio
United States	Northern Michigan Neurology	Traverse City	Michigan
United States	University of Arizona	Tucson	Arizona
United States	Crozer Chester Medical Center	Upland	Pennsylvania
United States	Virginia Beach General Hospital	Virginia Beach	Virginia
United States	John Muir Medical Center	Walnut Creek	California
United States	Mt Diablo Medical Center	Walnut Creek	California
United States	Bi-County Hospital	Warren	Michigan
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Rowan Regional Medical Center	Winston-Salem	North Carolina
United States	St. Elizabeth Health Center	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma US, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany,