Safety Study of Interferon Beta 1a to for Acute Stroke
Status:
Completed
Trial end date:
2011-04-08
Target enrollment:
Participant gender:
Summary
This study will examine the safety of the drug interferon beta 1a in patients with acute
ischemic stroke to determine the highest dose patients can tolerate without serious side
effects and to determine the best way to give the medication. Ischemic stroke is caused by a
blood clot blocking the flow of blood to brain tissue, causing loss or impairment of bodily
functions governed by the affected part of the brain. Interferon beta 1a is approved for use
in patients with multiple sclerosis to prevent further brain injury caused by inflammation;
the drug may also help prevent further brain injury in patients with acute stroke.
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)