Status:
COMPLETED
Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke
Lead Sponsor:
David Hess, MD
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Kentucky
Conditions:
Stroke, Acute
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.
Detailed Description
Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration (FDA) for treatment of infections and acne. However, doctors do not know whether minocycline will work in st...
Eligibility Criteria
Inclusion
- over 18 years of age
- acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
- onset of symptoms less than 6 hours
- measurable neurologic deficit (National Institutes of Health \[NIH\] Stroke Scale \>/= 1)
Exclusion
- allergy to tetracycline antibiotics
- women of child-bearing potential
- known hepatic and/or renal insufficiency
- Thrombocytopenia
- history of intolerance to minocycline
- dizziness at the time of stroke or in the past month (by self-report)
- aphasia likely to interfere with patients ability to report adverse effects
- previous functional disability
- stuporous or comatose
- presence of another serious illness likely to confound the study
- unlikely to be available for 90 day follow-up
- severe stroke (National Institutes of Health \[NIH\] Stroke Scale \>22)
- undergoing an interventional neuro-radiological intervention in first 12 hour
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00630396
Start Date
May 1 2008
End Date
January 1 2010
Last Update
January 13 2012
Active Locations (2)
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1
University of Kentucky
Lexington, Kentucky, United States, 40506-0057
2
Oregon Health & Science University
Portland, Oregon, United States, 97239