Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke (MINOS)
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|ClinicalTrials.gov Identifier: NCT00630396|
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : January 13, 2012
Last Update Posted : January 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute||Drug: Minocycline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minocycline to Improve Neurologic Outcome in Stroke (MINOS)|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
- Minocycline hydrochloride
- Minocycline hydrochloride injection
- Minomycin Intravenous (for drip use)
- Minomycin Intravenous
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
- Maximally Tolerated Dose of IV Minocycline [ Time Frame: 3 days ]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.
- 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. ]In eligible patients enrolled at Georgia Health Sciences University, blood samples were drawn for quantification of minocycline serum concentrations. This enabled the study team to determine the half life of the study drug.
- 90 Day Modified Rankin Scale Score [ Time Frame: 3 months ]The modified Rankin Scale (mRS) was performed in person at the 90 day clinic follow-up appointment. The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6. 0 represents no symptoms. 1 represents no significant disability. 2 represents slight disability. 3 represents moderate disability. 4 represents moderately severe disability. 5 represents severe disability. 6 represents death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630396
|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||Augusta University|