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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01805895
Recruitment Status : Completed
First Posted : March 6, 2013
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jeffrey Switzer, Augusta University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Minocycline Phase 1 Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minocycline in Acute Cerebral Hemorrhage (MACH) Trial
Actual Study Start Date : February 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
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.
 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
No Intervention: Control
This arm will not receive any minocycline. This arm will receive standard of care treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 90 days ]
    A blinded assessor will perform the modified Rankin Scale (this is the full scale name) after 90 days. This will serve as our efficacy endpoint. The scale measures function. It ranges from 0 to 6 with zero reflecting no disability, 1 to 5 increasing degrees of disability and 6 death. Lower numbers reflect preferred outcome. There are no sub scales.


Secondary Outcome Measures :
  1. Safety Assessment [ Time Frame: 90 days ]
    Adverse events will be asses for 90 days. This will serve as our safety endpoint.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01805895


Locations
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United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
American Heart Association
Investigators
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Principal Investigator: Jeffrey A Switzer, DO Augusta University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeffrey Switzer, Associate Professor, Augusta University
ClinicalTrials.gov Identifier: NCT01805895    
Other Study ID Numbers: Pro00000718
First Posted: March 6, 2013    Key Record Dates
Results First Posted: April 26, 2018
Last Update Posted: April 26, 2018
Last Verified: March 2018
Keywords provided by Jeffrey Switzer, Augusta University:
Stroke
Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage
 Hemorrhagic stroke
Hemorrhage
Minocycline
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents