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

Completed · Phase 2

Conditions studied: Cerebrovascular Accident

In brief

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.

Key facts

Study ID

NCT00044070

Run by

Astellas Pharma Inc

Starts

2000-12-01

Expected to finish

2003-01-01

Last updated by the study team

2006-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Phoenix Neurology Associates (Good Samaritan Hospital) — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Providence St. Joseph's Medical Center — Burbank, California, United States
• Grossmont Hospital — La Mesa, California, United States
• UCLA Emergency Medical Center — Los Angeles, California, United States
• Good Samaritan Hospital — San Jose, California, United States
• Santa Monica UCLA Medical Center — Santa Monica, California, United States
• John Muir Medical Center — Walnut Creek, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Bethesda Memorial Hospital — Boynton Beach, Florida, United States
• Holmes Regional Medical Center — Melbourne, Florida, United States
• University of Miami (Jackson Memorial Hospital) — Miami, Florida, United States
• Florida Neurovascular Institute — Tampa, Florida, United States
• DNA Research (Dekalb Medical Center) — Decatur, Georgia, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Parkview Hospital — Fort Wayne, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Louisville Neuroscience Research Center — Louisville, Kentucky, United States
• Cullicchia Neurology Clinic, LLP — Marrero, Louisiana, 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
• Wayne State University — Detroit, Michigan, United States
• Michigan State University — East Lansing, Michigan, United States
• University of South Alabama Stroke Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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