Safety Study of Interferon Beta 1a to for Acute Stroke

NCT00097318 | Completed Phase 1

• 2 other identifiers: 05003605-N-0036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cerebrovascular Accident

Keywords

Ischemic; Brain; Inflammation; Clinical Trial; Stroke

Interventions

Interferon beta-1a DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New focal neurologic deficit consistent with acute cerebral ischemia.
• Age greater than or equal to 18 and less than or equal to 85.
• Premorbid modified Rankin score 0-2 (functionally independent).
• Signed informed consent obtained from the patient or patient's legally authorized representative.
• Initiation of study drug within 24 hours of symptom onset.

You may not qualify if:

• Acute intracerebral hemorrhage.
• Major surgery planned within 30 days of symptom onset.
• Treatment with IV tPA or other recanalization therapy for current event.
• Pre-existing medical, neurological or psychiatric disease that would confound the outcome evaluations.
• Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
• Coma or altered level of consciousness (score of 1 or more on LOC items of NIHSS score).
• Hemodynamic instability.
• Current participation in another experimental treatment protocol.
• Inadequate liver function, defined by a total bilirubin, AST or ALT or alkaline phosphatase greater than 2 times the upper limit of normal values.
• Renal impairment with serum creatinine greater than 2.0 mg/dl.
• NIHSS greater than 18.
• Prior use of interferon.
• Active major infection.
• Allergy to human serum albumin, mannitol.
• Seizure disorder or seizure at onset of stroke.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (3)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Hallenbeck JM, Dutka AJ. Background review and current concepts of reperfusion injury. Arch Neurol. 1990 Nov;47(11):1245-54. doi: 10.1001/archneur.1990.00530110107027.

  PMID: 2241624 BACKGROUND

• Kochanek PM, Hallenbeck JM. Polymorphonuclear leukocytes and monocytes/macrophages in the pathogenesis of cerebral ischemia and stroke. Stroke. 1992 Sep;23(9):1367-79. doi: 10.1161/01.str.23.9.1367.

  PMID: 1519296 BACKGROUND

• Feuerstein GZ, Wang X, Barone FC. The role of cytokines in the neuropathology of stroke and neurotrauma. Neuroimmunomodulation. 1998 May-Aug;5(3-4):143-59. doi: 10.1159/000026331.

  PMID: 9730680 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemia; Inflammation

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 20, 2004
• First Posted: November 22, 2004
• Study Start: November 17, 2004
• Study Completion: April 8, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-04-08

Locations

US (3)