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A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients (MACH)

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ClinicalTrials.gov Identifier: NCT01805895
Recruitment Status : Unknown
Verified February 2016 by Jeffrey Switzer, Georgia Regents University.
Recruitment status was:  Recruiting
First Posted : March 6, 2013
Last Update Posted : February 10, 2016
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jeffrey Switzer, Georgia Regents University

March 5, 2013
March 6, 2013
February 10, 2016
February 2013
December 2016   (Final data collection date for primary outcome measure)
modified Rankin Scale [ Time Frame: 90 days ]
A blinded assessor will perform the modified Rankin Scale after 90 days to determine functional outcome. This will serve as our efficacy endpoint.
  • modified Rankin Scale [ Time Frame: 90 days ]
    A blinded assessor will perform the modified Rankin Scale after 90 days to determine functional outcome. This will serve as our efficacy endpoint.
  • Safety assessment [ Time Frame: 90 days ]
    Adverse events will be assessed for 90 days. This will serve as our safety endpoint.
Complete list of historical versions of study NCT01805895 on ClinicalTrials.gov Archive Site
Safety Assessment [ Time Frame: 90 days ]
Adverse events will be asses for 90 days. This will serve as our safety endpoint.
Not Provided
Not Provided
Not Provided
 
A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients
Minocycline in Acute Cerebral Hemorrhage (MACH) Trial
The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorrhage patients.
MACH is a randomized trial of minocycline in intracerebral hemorrhage. 24 total subjects will be randomly assigned to minocycline or control (1:1). The first dose will be given intravenously. Subsequent doses will be given orally every 24 hours for a total of five doses. The study will test to see if the medication is safe in intracerebral hemorrhage. The pharmacokinetics of minocycline in intracerebral hemorrhage will be determined and the impact of minocycline on blood biomarkers.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Intracerebral Hemorrhage
Drug: Minocycline
This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.
Other Name: Dynacin, Minocin
  • Experimental: Minocycline
    This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.
    Intervention: Drug: Minocycline
  • No Intervention: Control
    This arm will not receive any minocycline. This arm will receive standard of care treatment.
Fouda AY, Newsome AS, Spellicy S, Waller JL, Zhi W, Hess DC, Ergul A, Edwards DJ, Fagan SC, Switzer JA. Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial. Stroke. 2017 Oct;48(10):2885-2887. doi: 10.1161/STROKEAHA.117.018658. Epub 2017 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
24
March 2017
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older.
  • Intracerebral hemorrhage documented by CT scan
  • The first dose of the drug can be administered within 12 hours of time last known to be at baseline

Exclusion Criteria:

  • Allergy to tetracycline antibiotics
  • Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
  • Hepatic and/or renal insufficiency (LFT's >3x upper limit of normal; Creatinine >2mg/dL)
  • History of intolerance to minocycline
  • National Institutes of Health Stroke Scale score of 4 or less
  • Glasgow Coma Scale score of 5 or less
  • Surgical evacuation of hematoma planned within 24 hours
  • Secondary intracerebral hemorrhage resulting from trauma, arteriovenous malformation, aneurysm, tumor or other causes
  • Thrombocytopenia (platelet count <75,000/mm3) or coagulopathy (INR >1.4)
  • Previously not independent (prestroke modified Rankin scale score >2)
  • Suspected of not being able to comply with the study protocol
  • Unlikely to be available for 90 day follow-up
  • Pre-existing Do Not Resuscitate (DNR) order or indication that a new DNR order will be implemented within the first 48 hours of hospitalization
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01805895
Pro00000718
Yes
Not Provided
Not Provided
Jeffrey Switzer, Georgia Regents University
Augusta University
American Heart Association
Principal Investigator: Jeffrey A Switzer, DO Augusta University
Augusta University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP