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

Tracking Information
First Received Date ^ICMJE	August 16, 2002
Last Updated Date	March 31, 2006
Start Date ^ICMJE	December 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00044070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
Official Title ^ICMJE	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
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control
Condition ^ICMJE	Cerebrovascular Accident
Intervention ^ICMJE	Drug: YM872 (zonampanel)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	January 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Austria, Belgium, Canada, Germany, South Africa

Administrative Information
NCT ID ^ICMJE	NCT00044070
Responsible Party
Study ID Numbers ^ICMJE	872-CL-003
Study Sponsor ^ICMJE	Astellas Pharma Inc
Collaborators ^ICMJE	Astellas Pharma US, Inc.
Investigators ^ICMJE
Information Provided By	Astellas Pharma Inc
Verification Date	March 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP