Status:
COMPLETED
Safety Study of Interferon Beta 1a to for Acute Stroke
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Cerebrovascular Accident
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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 determi...
Detailed Description
Objectives: Recombinant human interferon beta-1a (IFN-Beta1a) is an FDA approved treatment for patients with relapsing remitting multiple sclerosis, in whom the safety profile is well characterized. T...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adult male or female patients with confirmed acute ischemic stroke, presenting within 24 hours of symptom onset and meeting inclusion criteria at each of the study sites will be assessed for possible enrollment into the study.
- 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.
- EXCLUSION CRITERIA:
- 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.
- Severe depressive disorder and/or suicidal ideation.
- Significant leukopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days prior to symptom onset.
Exclusion
Key Trial Info
Start Date :
November 17 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 8 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00097318
Start Date
November 17 2004
End Date
April 8 2011
Last Update
July 2 2017
Active Locations (3)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Suburban Hospital
Bethesda, Maryland, United States, 20814
3
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892