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| Sponsor: | David Hess, MD |
|---|---|
| Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) University of Kentucky Oregon Health and Science University |
| Information provided by (Responsible Party): | David Hess, MD, Georgia Health Sciences University |
| ClinicalTrials.gov Identifier: | NCT00630396 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke, Acute |
Drug: Minocycline |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Minocycline to Improve Neurologic Outcome in Stroke (MINOS) |
| Enrollment: | 60 |
| Study Start Date: | May 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
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
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40506-0057 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | David C Hess, MD | Georgia Health Sciences University |
More Information
| Responsible Party: | David Hess, MD, Professor and Chairman, Georgia Health Sciences University |
| ClinicalTrials.gov Identifier: | NCT00630396 History of Changes |
| Other Study ID Numbers: | RO1 NS055728-01A1, 07-02-202 |
| Study First Received: | February 28, 2008 |
| Results First Received: | August 1, 2011 |
| Last Updated: | December 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
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) |
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Minocycline Tissue Plasminogen Activator Neuroprotective Agents |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents |