Clinical trial NCT00630396: Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke
Official title: Minocycline to Improve Neurologic Outcome in Stroke (MINOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke, Acute
Keywords: stroke
ischemic
neuroprotection
minocycline
tissue plasminogen activator (tPA)
biomarkers
pharmacokinetics
antiapoptotic
anti-inflammatory
treatment
matrix metalloproteinase-9 (MMP-9)
thrombolysis
Minocycline to Improve Neurologic Outcome in Stroke (MINOS)
cerebrovascular stroke
cerebrovascular accident
cerebral stroke
cerebrovascular accident (CVA)
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Kentucky
name: Oregon Health and Science University
First posted: 2008-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 does not have a lot of side effects, investigators at Georgia Health Sciences University (formerly the Medical College of Georgia) believe that it might be a safe and effective drug to improve the outcome in patients with stroke.

Eligibility 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 (National Institutes of Health \[NIH\] Stroke Scale \>/= 1)

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 (National Institutes of Health \[NIH\] Stroke Scale \>22)
* undergoing an interventional neuro-radiological intervention in first 12 hour

Primary outcomes:
measure: Maximally Tolerated Dose of IV Minocycline
timeFrame: 3 days
Secondary outcomes:
measure: Half-life of IV Minocycline
timeFrame: For each subject blood samples were drawn before dose #1 and one hour after starting dose #1. Additional blood was drawn 1, 6, 12, 24, 48, and 72 hours after starting dose #6, which lasted approximately 6 days.
measure: 90 Day Modified Rankin Scale Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Augusta University
name: David C Hess, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fagan SC, Waller JL, Nichols FT, Edwards DJ, Pettigrew LC, Clark WM, Hall CE, Switzer JA, Ergul A, Hess DC. Minocycline to improve neurologic outcome in stroke (MINOS): a dose-finding study. Stroke. 2010 Oct;41(10):2283-7. doi: 10.1161/STROKEAHA.110.582601. Epub 2010 Aug 12.