Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke
MINOS
Minocycline to Improve Neurologic Outcome in Stroke (MINOS)
2 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
January 13, 2012
CompletedJanuary 13, 2012
December 1, 2011
1.7 years
February 28, 2008
August 1, 2011
December 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximally Tolerated Dose of IV Minocycline
Investigators closely monitored each subject for evidence of minocycline intolerance. All adverse events were immediately reported for a decision whether to discontinue the study medication and/or reduce the dose. A computer program was used to determine the maximum tolerated dose. After entering information regarding doses and expected toxicities, results for each subject as they were collected were entered. The computer program informed as to (de)escalation, or maintenance of the same dose in the subsequent cohort of enrolled patients.
3 days
Secondary Outcomes (2)
Half-life of IV Minocycline
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.
90 Day Modified Rankin Scale Score
3 months
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Hess, MDlead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- University of Kentuckycollaborator
- Oregon Health and Science Universitycollaborator
Study Sites (2)
University of Kentucky
Lexington, Kentucky, 40506-0057, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Publications (1)
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.
PMID: 20705929RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Some statistical tests could not be performed due to small sample size in the 4.5 and 6mg/kg dose tiers. The modified continual reassessment method (CRM) failed to identify the maximum tolerated dose of intravenous minocycline.
Results Point of Contact
- Title
- David Hess, MD
- Organization
- Georgia Health Sciences University
Study Officials
- PRINCIPAL INVESTIGATOR
David C Hess, MD
Augusta University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor and Chairman
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
January 13, 2012
Results First Posted
January 13, 2012
Record last verified: 2011-12