Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke
Information source: Medical College of Georgia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke, Acute
Intervention: Minocycline (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Medical College of Georgia Official(s) and/or principal investigator(s):
David C Hess, MD, Principal Investigator, Affiliation: Medical College of Georgia
Overall contact:
David C Hess, MD, Phone: 706-721-1691, Email: dhess@mcg.edu
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.
Clinical Details
Official title: Minocycline to Improve Neurologic Outcome (MINO Clinical Trial)
Study design: Treatment, Open Label, Single Group Assignment, Safety Study
Primary outcome: The objective of this project is to determine the maximally tolerated intravenous dose of minocycline in ischemic stroke patients.
Secondary outcome: Determine the pharmacokinetics of Minocycline in patients with ischemic strokeDetermine the effect of the different doses of MC on plasma MMP-9 activity. Gather preliminary data of the effect of different doses of MC on functional outcome
Detailed description:
Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration
for treatment of infections and acne. However, doctors don't yet know whether minocycline
will work in stroke patients. Its use in stroke patients is experimental. There is a lot of
information from experimental stroke studies in animals that minocycline lessens the damage
from a stroke and the animals recover better. Since minocycline is generally a very safe
drug in humans and doesn't have a lot of side effects, investigators at the Medical College
of Georgia believe that it might be a safe and effective drug to improve the outcome in
patients with stroke.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 (NIH >22)
- undergoing an interventional neuro-radiological intervention in first 12 hour
Locations and Contacts
David C Hess, MD, Phone: 706-721-1691, Email: dhess@mcg.edu
University of Kentucky, Lexington, Kentucky 40506-0057, United States; Recruiting
L. Creed Pettigrew, MD, Phone: 859-323-6702, Email: cpetti@uky.edu
L. Creed Pettigrew, MD, Principal Investigator
Oregon Health Sciences University, Portland, Oregon 97239, United States; Recruiting
Wayne Clark, MD, Phone: 503-494-7225, Email: clarkw@ohsu.edu
Rebecca Stone, Phone: 503-418-1862, Email: stoner@ohsu.edu
Wayne Clark, MD, Principal Investigator
Additional Information
Starting date: May 2008
Ending date: October 2009
Last updated: February 5, 2009
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