Official Title: “Minocycline to Improve Neurologic Outcome (MINO Clinical Trial)”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Safety Study

Study Primary Completion Date: October 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Minocycline
  • Dose level 1 = 3mg/kg IV(intravenous)initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses. Dose level 2 = 4.5mg/kg IV(intravenous) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses. Dose level 3 = 6 mg/kg IV(intravenous) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses. Dose level 4 = 10 mg/kg IV (intravenous) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses

Primary Measures

• The objective of this project is to determine the maximally tolerated intravenous dose of minocycline in ischemic stroke patients.
  • Time Frame: 18 months
    Safety Issue?: Yes

Secondary Measures

• Determine the pharmacokinetics of Minocycline in patients with ischemic stroke
  • Time Frame: 18 months
    Safety Issue?: No
• Determine the effect of the different doses of MC on plasma MMP-9 activity.
  • Time Frame: 2 years
    Safety Issue?: No
• Gather preliminary data of the effect of different doses of MC on functional outcome
  • Time Frame: 2 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Medical College of Georgia

Overall Clinical Trial Officials and Contacts

David C Hess, MD Principal Investigator Medical College of Georgia  

Overall Contact: David C Hess, MD 706-721-1691 dhess@mcg.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00630396

Study ID Number: RO1 NS055728-01A1

ClinicalTrials.gov Identifier: NCT00630396

Health Authority: United States: Food and Drug Administration