A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients

Cerebrovascular Accident Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044070
• Other study ID #: 872-CL-003
• 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

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.

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 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

Exclusion Criteria:

• 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.

• 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

• Cerebrovascular Accident
• Stroke

Intervention

Drug:
• YM872 (zonampanel)

Locations

Country	Name	City	State
Austria	Universitätsklinik Allgemeines	Wien
Belgium	Hopital Erasme	Brussels
Belgium	Service de Neurologie, Cliniques Universitaires St.-Luc	Bruxelles
Belgium	Dienst Neurologie UZ Gasthuisberg	Leuven
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Royal Jubilee Hospital	Victoria	British Columbia
Germany	Universitätsklinikum Aachen, Neurologische Klinik	Aachen
Germany	University of Essen	Essen
Germany	Neurologische Universitätsklinik, Albert-Ludwigs-University	Freiburg
Germany	Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie	Hamburg-Eppendorf
Germany	Universitatklinikum Homburg, Neurologie Klinik und Poliklinik	Homburg Saar
Germany	Friedrich-Schiller-University	Jena
Germany	Universität zu Köln klinik und poliklinik fur neurology	Koln
Germany	Universitatklinikum Leipzig	Leipzig
Germany	Universitätsklinik Mainz	Mainz
Germany	Department of Neurology Klinikum	Minden
Germany	Neurologische Klinik Klinikum Rechts der Isar der TU Munchen	Munchen
Germany	Neurologische Klinik Knappschafts - krankenhause	Recklinghausen
Germany	Dr.-H.-Schmidt-Kliniken Ludwig-Erhar	Wiesbaden
South Africa	Muelmed Hospital	Arcadia
South Africa	Bloemfontein Medi-Clinic	Bloemfontein
South Africa	Groote Schuur Hospital	Cape Town
South Africa	St. Augustine's Hospital	Durban
South Africa	Sandton Medi-Clinic	Johannesburg
South Africa	Pietermaritzburg Medi-Clinic	Pietermaritzburg
South Africa	Little Company of Mary Medical Centre	Pretoria
South Africa	Vergelegen Medi-Clinic	Somerset West
South Africa	Sunninghill Hospital	Sunninghill
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	Johns Hopkins Medical Institute	Baltimore	Maryland
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	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	DNA Research (Dekalb Medical Center)	Decatur	Georgia
United States	Wayne State University	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	Parkview Hospital	Fort Wayne	Indiana
United States	Advanced Neurology Specialists (Benefis Healthcare Hospital)	Great Falls	Montana
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas (Houston Medical Center)	Houston	Texas
United States	Grossmont Hospital	La Mesa	California
United States	University of Kentucky	Lexington	Kentucky
United States	UCLA Emergency Medical Center	Los Angeles	California
United States	Louisville Neuroscience Research Center	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Cullicchia Neurology Clinic, LLP	Marrero	Louisiana
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	University of Miami (Jackson Memorial Hospital)	Miami	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	St. Patrick's Hospital & Health Sciences Center	Missoula	Montana
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	St. Luke's Hospital	New York	New York
United States	Providence St. Peter Hospital	Olympia	Washington
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Phoenix Neurology Associates (Good Samaritan Hospital)	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Stroke Institute	Pittsburgh	Pennsylvania
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	William Beaumont Hospital	Royal Oak	Michigan
United States	Field Neurosciences Institute (St. Mary's Hospital)	Saginaw	Michigan
United States	Good Samaritan Hospital	San Jose	California
United States	Santa Monica UCLA Medical Center	Santa Monica	California
United States	Ellis Hospital	Schenectady	New York
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Stony Brook Hospital	Stony Brook	New York
United States	Florida Neurovascular Institute	Tampa	Florida
United States	Medical College of Ohio	Toledo	Ohio
United States	University of Arizona	Tucson	Arizona
United States	Virginia Beach General Hospital	Virginia Beach	Virginia
United States	John Muir Medical Center	Walnut Creek	California
United States	All-Trials Clinical Research, LLC (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,  South Africa,