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)”

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.

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.

Intervention(s) in this Clinical Trial

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

Primary Measures

• Maximally Tolerated Dose of IV Minocycline
  • Time Frame: 3 days
    Safety Issue?: Yes

Secondary Measures

• Half-life of IV Minocycline
  • Time Frame: 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.
    Safety Issue?: No
• 90 Day Modified Rankin Scale Score
  • Time Frame: 3 months
    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 (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

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 Investigator: David Hess, MD Other

Overall Clinical Trial Officials and Contacts

David C Hess, MD Principal Investigator Georgia Health Sciences University  

Information obtained from ClinicalTrials.gov on February 12, 2012

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