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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00044057

Collaborator

Astellas Pharma US, Inc. (Industry)

118

Locations

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: YM872 (zonampanel), t-PA (alteplase)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2000

Study Completion Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	University of South Alabama Stroke Center	Mobile	Alabama	United States
2	Good Samaritan Hospital	Phoenix	Arizona	United States
3	University of Arizona	Tucson	Arizona	United States
4	East Bay Region Associates in Neurology	Berkeley	California	United States
5	Providence St. Joseph's Medical Center	Burbank	California	United States
6	Mercy San Juan Hospital	Carmichael	California	United States
7	University of California Davis Medical Center	Davis	California	United States
8	Scripps Memorial Hospital	Encinitas	California	United States
9	Grossmont Hospital	La Mesa	California	United States
10	UCLA Medical Center	Los Angeles	California	United States
11	Tri-City Medical Center	Oceanside	California	United States
12	Stanford University Medical Center	Palo Alto	California	United States
13	Mercy General Hospital	Sacramento	California	United States
14	Scripps Mercy Hospital	San Diego	California	United States
15	University of California at San Diego	San Diego	California	United States
16	Good Samaritan Hospital	San Jose	California	United States
17	UCLA Medical Center - Santa Monica	Santa Monica	California	United States
18	John Muir Medical Center	Walnut Creek	California	United States
19	Mt Diablo Medical Center	Walnut Creek	California	United States
20	Colorado Neurological Institute	Englewood	Colorado	United States
21	Bridgeport Hospital	Bridgeport	Connecticut	United States
22	Columbia JFK Hospital	Atlantis	Florida	United States
23	Bethesda Memorial Hospital	Boynton Beach	Florida	United States
24	Lakeland Regional Medical Center	Lakeland	Florida	United States
25	Holmes Regional Medical Center	Melbourne	Florida	United States
26	Bay Medical Center	Panama City	Florida	United States
27	St Joseph's Hospital	Tampa	Florida	United States
28	Tampa General Hospital	Tampa	Florida	United States
29	St Francis Hospital	Columbus	Georgia	United States
30	DNA Research (Dekalb Medical Center)	Decatur	Georgia	United States
31	Candler Hospital	Savannah	Georgia	United States
32	St Joseph Hospital	Savannah	Georgia	United States
33	Queen's Medical Center	Honolulu	Hawaii	United States
34	OSF St. Francis Medical Center	Peoria	Illinois	United States
35	Parkview Hospital	Fort Wayne	Indiana	United States
36	Methodist Hospital	Indianapolis	Indiana	United States
37	Louisville Neuroscience Research Center	Louisville	Kentucky	United States
38	Culicchia Neurology Clinic, LLP	Marrero	Louisiana	United States
39	University of Maryland Medical System	Baltimore	Maryland	United States
40	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States
41	New England Medical Center	Boston	Massachusetts	United States
42	St John's Hospital	Detroit	Michigan	United States
43	Michigan State University	East Lansing	Michigan	United States
44	William Beaumont Hospital	Royal Oak	Michigan	United States
45	Northern Michigan Neurology	Traverse City	Michigan	United States
46	Bi-County Hospital	Warren	Michigan	United States
47	Research Medical Center	Kansas City	Missouri	United States
48	Advanced Neurology Specialists (Benefis Healthcare Hospital)	Great Falls	Montana	United States
49	Washoe Comprehensive Stroke Center	Reno	Nevada	United States
50	JFK Medical Center	Edison	New Jersey	United States
51	Muhlenberg Regional Medical Center	Plainfield	New Jersey	United States
52	Neurology Group of Bergen County (Valley Hospital)	Ridgewood	New Jersey	United States
53	University of New Mexico Hospital	Albuquerque	New Mexico	United States
54	VA Medical Center	Albuquerque	New Mexico	United States
55	Albany Medical Center	Albany	New York	United States
56	Buffalo General Hospital	Buffalo	New York	United States
57	North Shore University Hospital	Manhasset	New York	United States
58	Long Island Jewish Medical Center	New Hyde Park	New York	United States
59	Columbia Presbyterian Medical Center	New York	New York	United States
60	Roosevelt Hospital	New York	New York	United States
61	St. Luke's Hospital	New York	New York	United States
62	Rochester General Hospital	Rochester	New York	United States
63	Ellis Hospital	Schenectady	New York	United States
64	Stony Brook Hospital	Stony Brook	New York	United States
65	Forsyth Medical Center	Winston-Salem	North Carolina	United States
66	Rowan Regional Medical Center	Winston-Salem	North Carolina	United States
67	Akron General Medical Center	Akron	Ohio	United States
68	Metrohealth Medical Center	Cleveland	Ohio	United States
69	Riverside Methodist Hospital	Columbus	Ohio	United States
70	Medical College of Ohio	Toledo	Ohio	United States
71	St. Elizabeth Health Center	Youngstown	Ohio	United States
72	Lehigh Valley Hospital	Allentown	Pennsylvania	United States
73	Geisinger Medical Center	Danville	Pennsylvania	United States
74	Westmoreland Regional Hospital	Greensburg	Pennsylvania	United States
75	Hershey Medical Center	Hershey	Pennsylvania	United States
76	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States
77	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States
78	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States
79	University of Pittsburgh Medical Center Stroke Institute	Pittsburgh	Pennsylvania	United States
80	Crozer Chester Medical Center	Upland	Pennsylvania	United States
81	Miriam Hospital	Providence	Rhode Island	United States
82	Roper Hospital	Charleston	South Carolina	United States
83	Chattanooga Neurology Associates (Erlanger Hospital)	Chattanooga	Tennessee	United States
84	Chattanooga Neurology Associates (Memorial Hospital)	Chattanooga	Tennessee	United States
85	St. Thomas Hospital	Nashville	Tennessee	United States
86	Vanderbilt University Medical Center	Nashville	Tennessee	United States
87	University of Texas (Houston Medical Center)	Houston	Texas	United States
88	Neurological Research Center, Inc	Bennington	Vermont	United States
89	Neurology Associates, Inc. (St. Mary's Hospital)	Richmond	Virginia	United States
90	Virginia Beach General Hospital	Virginia Beach	Virginia	United States
91	Stevens Memorial Hospital	Edmonds	Washington	United States
92	Providence St. Peter Hospital	Olympia	Washington	United States
93	St. Luke's Medical Center	Milwaukee	Wisconsin	United States
94	Theda Clark Medical Center	Neenah	Wisconsin	United States
95	Universitätsklinik allgemeines Krankenhaus der Stadt Wien	Wien		Austria
96	Dienst Neurologie UZ Gasthuisberg	Leuven		Belgium
97	Foothills Medical Centre	Calgary	Alberta	Canada
98	University of Alberta Hospital	Edmonton	Alberta	Canada
99	Penticton Regional Hospital	Penticton	British Columbia	Canada
100	Vancouver General Hospital	Vancouver	British Columbia	Canada
101	Royal Jubilee Hospital	Victoria	British Columbia	Canada
102	Victoria General Hospital	Victoria	British Columbia	Canada
103	Charles LeMoyne Hospital	Greenfield Park	Quebec	Canada
104	Notre-Dame Hospital	Montreal	Quebec	Canada
105	Pavillion St Joseph	Trois Rivers	Quebec	Canada
106	Royal University Hospital	Saskatoon	Saskatchewan	Canada
107	Universitätsklinikum Aachen, Neurologische Klinik	Aachen		Germany
108	University Essen	Essen		Germany
109	Neurologische Universitätsklinik	Freiburg		Germany
110	Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie	Hamburg-Eppendorf		Germany
111	Neurology Klinik Klinikum Hanover	Hanover		Germany
112	Friedrich-Schiller-University	Jena		Germany
113	Universität zu Köln klinik und poliklinik fur neurology	Köln		Germany
114	Universitätsklinikum Leipzig	Leipzig		Germany
115	Universitätsklinik Mainz	Mainz		Germany
116	Neurologische Klinik Klinikum Rechts der Isar der TU Munchen	Munchen		Germany
117	Neurologische Klinik Knappschafts - krankenhause	Recklinghausen		Germany
118	Neurologisch Psychiayrische Klinik	Weisbaden		Germany

Sponsors and Collaborators

Astellas Pharma Inc
Astellas Pharma US, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00044057

Other Study ID Numbers:

872-CL-004

First Posted:

Aug 20, 2002

Last Update Posted:

Apr 3, 2006

Last Verified:

Mar 1, 2006

Keywords provided by , ,

ARTIST

Additional relevant MeSH terms:

Ischemic Stroke

Tissue Plasminogen Activator

Study Results

No Results Posted as of Apr 3, 2006