Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke (MINOS)

This study has been completed.
Sponsor:
Collaborators:
University of Kentucky
Oregon Health and Science University
Information provided by (Responsible Party):
David Hess, MD, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT00630396
First received: February 28, 2008
Last updated: December 9, 2011
Last verified: December 2011
Results First Received: August 1, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stroke, Acute
Intervention: Drug: Minocycline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred from June 3, 2008 to October 10, 2009. The study was completed ahead of schedule. Study subjects were enrolled in each recruiting centers' Emergency Department or stroke intensive care unit. Many subjects came as transfers from rural or outside hospitals to one of the enrolling centers for further care and study participation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Potential patients that met all of the inclusion criteria, did not meet any of the exclusion criteria, and were willing to participate were enrolled in the study. All study subjects were given one of the four doses of minocycline. The dose of minocycline given was assigned by a computer program.

Reporting Groups
  Description
Minocycline All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.

Participant Flow:   Overall Study
    Minocycline  
STARTED     60  
COMPLETED     53  
NOT COMPLETED     7  
Death                 4  
Lost to Follow-up                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Minocycline All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.

Baseline Measures
    Minocycline  
Number of Participants  
[units: participants]
  60  
Age  
[units: Participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     30  
Age  
[units: years]
Mean ± Standard Deviation
 
Overall age     65  ± 13.7  
Gender  
[units: participants]
 
Female     28  
Male     32  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     9  
White     50  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     60  
Weight  
[units: Kg]
Mean ± Standard Deviation
  81.6  ± 21.6  
Subjects receiving t-PA then minocycline [1]
[units: Participants]
 
Total amount of subjects that received t-PA     36  
Total amount of subjects that did not receive t-PA     24  
NIH Stroke Scale at baseline [2]
[units: Units on a scale]
Mean ± Standard Deviation
  8.7  ± 5.8  
Symptom onset to study drug infusion time [3]
[units: minutes]
Mean ± Standard Deviation
  307.4  ± 50.0  
[1] Patients that received tissue plasminogen activator (tPA) were also eligible for the MINOS trial. Once tPA had finished infusing, the research team would commence with the study drug infusion.
[2] The National Institutes of Health (NIH) Stroke Scale was designed to assess, score, and reliably communicate the level of impairment in a stroke patient. The maximum score is a 42, and the minimum score is a 0. A 42 represents the most severe stroke as scored by the NIH Stroke Scale.
[3] This is the average time from when the patient was "last known to be normal" to the moment the study drug began infusing intravenously.



  Outcome Measures
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1.  Primary:   Maximally Tolerated Dose of IV Minocycline   [ Time Frame: 3 days ]

2.  Secondary:   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. ]

3.  Secondary:   90 Day Modified Rankin Scale Score   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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:  
Name/Title: David Hess, MD
Organization: Georgia Health Sciences University
phone: 706-721-1691
e-mail: dhess@georgiahealth.edu


Publications of Results:

Responsible Party: David Hess, MD, 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