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

This study is currently recruiting participants.
Verified March 2013 by Georgia Regents University
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01805895
First received: March 5, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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 Intervention Phase
Intracerebral Hemorrhage
 Drug: Minocyline
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minocycline in Acute Cerebral Hemorrhage (MACH) Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Adverse events will be assessed for 90 days. This will serve as our safety endpoint.


Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline
This arm will receive a total of 5 doses of minocycline. There will be 1 dose of intravenous minocycline followed by 4 doses of oral (pill) minocycline. Each dose is 24 hours apart.
 Drug: Minocyline
No Intervention: Control
This arm will not receive any minocycline

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 6 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805895

Contacts
Contact: Jeffrey Switzer, DO 706-721-1691 jswitzer@gru.edu
Contact: Mary Anne Park, RN 706-721-0193 mpark@gru.edu

Locations
United States, Georgia
Georgia Health Sciences University Recruiting
Augusta, Georgia, United States, 30912
Contact: Jeffrey Switzer, DO     706-721-1691     jswitzer@gru.edu    
Principal Investigator: Jeffrey Switzer, DO            
Sub-Investigator: David Hess, MD            
Sub-Investigator: Askiel Bruno, MD            
Sub-Investigator: Fenwick Nichols, MD            
Sub-Investigator: Hartmut Gross, MD            
Sub-Investigator: Susan Fagan, PharmD            
Sponsors and Collaborators
Georgia Regents University
American Heart Association
Investigators
Principal Investigator: Jeffrey Switzer, DO Georgia Regents University
  More Information

No publications provided

Responsible Party: Georgia Regents University
ClinicalTrials.gov Identifier: NCT01805895     History of Changes
Other Study ID Numbers: Pro00000718
Study First Received: March 5, 2013
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgia Regents University:
Stroke
Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage
 Hemorrhagic stroke
Hemorrhage
Minocycline

Additional relevant MeSH terms:
Hemorrhage
Cerebral 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013