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Protocol Number: 05-N-0036 
Patients between 18 and 85 years of age who have had a stroke and who can begin taking the study drug within 24 hours of onset of stroke symptoms may be eligible for this study. Candidates are screened with a medical history, physical examination and neurological examinations, blood tests, electrocardiogram, and brain imaging with magnetic resonance imaging (MRI) or computed tomography (CT) scans. Participants are randomly assigned to receive either interferon beta 1a or placebo (an inactive substance). For every five patients enrolled, four receive the study drug and one receives placebo. The dose of interferon beta 1a is increased in successive groups of patients, so that the first group to enter the study receives 11 micrograms (mcg) of the drug, the next receives 22 mcg, then 44 mcg, 66 mcg, and 88 mcg. All patients receive their first dose intravenously (through a vein); additional doses are given subcutaneously (under the skin). During their hospital stay all participants receive standard medical care for stroke, have neurological checks every 6 hours, and have continuous heart monitoring. To prevent fever, they receive medication, such as Tylenol, before each dose of interferon beta 1a or placebo and every 6 hours as needed while taking the study drug. Routine blood tests are done at 3 and 7 days after the first dose of study drug (or at discharge if the patient leaves the hospital before 7 days) and again at 14, 21, and 28 days. Neurological examinations are done 24 hours after starting the study medication, then every day for 14 days, and again on day 28. After discharge from the hospital, patients are seen by a nurse every day foan 14 days after the first medication dose. They are contacted by phone on days 17 and 21. On day 28 they return to the hospital as an outpatient for a neurological assessment and blood tests.
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National Institutes of Health Clinical Center