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Use of Minocycline in Intracerebral Hemorrhage

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: NCT03040128
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Jason Chang, University of Tennessee Health Science Center

Brief Summary:
To date, no neuroprotective drugs have demonstrated clinical efficacy in intracerebral hemorrhage (ICH). This study will use intravenous (IV) minocycline in ICH to evaluate for (1) safety/ tolerability and (2) evaluate for clinical efficacy

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Minocycline Other: normal saline infusion Phase 1 Phase 2

Detailed Description:
Intracerebral hemorrhage (ICH) remains a devastating neurological disorder with high mortality and poor prognosis with unchanged mortality rates (53-59%). Acute treatment options for ICH remain supportive with no available effective drug or surgical therapy. All trials so far have failed to improve clinical outcome in randomized, double-blinded trials. However, one area of interest has been maintaining the integrity of the blood-brain-barrier (BBB) and preventing the growth of vasogenic edema. Matrix metalloproteinases (MMP) are a family of ubiquitous zinc-dependent endopeptidase enzymes whose primary function is the digestion of collagen type IV, laminin, and fibronectin for the purpose of remodeling extracellular basal lamina. Elevated MMP-9 as a pathological process associated with larger hematoma volume, larger perihematomal edema, and poorer clinical outcome in intracerebral hemorrhage is well documented in animal models and patients. One particular MMP-9 inhibitor gaining usage in cerebrovascular disease is minocycline. Normally FDA-approved for bacterial infection and acne vulgaris, minocycline has also been found to be both a safe and effective treatment in ischemic stroke; its potential role as a neuroprotectant in ischemic stroke is currently being tested in a large, randomized, double-blinded trial. Minocycline's beneficial role as a neuroprotectant may also extend to ICH. By inhibiting MMP-9, minocycline may decrease BBB permeability, resulting in less perihematomal edema and decreased mass effect. Although numerous animal ICH models support minocycline's role as an inhibitor of MMP-9 and neuroprotectant, its use has never been studied in humans with ICH.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: random number generator (placebo vs. study drug)
Primary Purpose: Treatment
Official Title: Minocycline and Matrix Metalloproteinase Inhibition in Acute Intracerebral Hemorrhage: A Pilot Trial
Actual Study Start Date : June 27, 2013
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Placebo Comparator: placebo
normal saline infusion
Other: normal saline infusion
Experimental: minocycline
intravenous minocycline
Drug: Minocycline
high-dose, intravenous minocycline




Primary Outcome Measures :
  1. Number of patients with Treatment-related Adverse Effects [ Time Frame: day 90 ]
    Treatment-related adverse effects as noted by package insert: fever, nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury)


Secondary Outcome Measures :
  1. Volume (ml) of Perihematomal Edema [ Time Frame: Change from baseline perihematomal edema volume to chronic (day 5-11) perihematomal edema volume ]
    Volumetric analysis (ml) computed from computed tomography head

  2. modified Rankin score [ Time Frame: day 90 ]
    modified Rankin score (points ranging from 0 to 6)

  3. Barthel Index [ Time Frame: day 90 ]
    Barthel Index score (points ranging from 0 to 100)

  4. National Institutes of Health Stroke Scale Score [ Time Frame: day 90 ]
    National Institutes of Health Stroke Scale Score (points ranging from 0 to 42)

  5. Glasgow Coma Score [ Time Frame: day 90 ]
    Glasgow Coma Score (points ranging from 3 to 15)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Age 18-80 yo
  2. Acute neurological deficit with corresponding ICH noted on head CT
  3. Glasgow Coma Scale (GCS) > 8
  4. Onset of symptoms within 12 hrs
  5. < 30 ml of blood noted on initial CTH (30 ml hematoma volume is a noted independent marker between good and poor clinical outcome)
  6. ICH score < 3
  7. English/ Spanish speaking

Exclusion Criteria:

  1. Allergy to tetracycline and tetracycline analogues
  2. Pregnancy or suspected pregnancy
  3. Hepatic and/or renal insufficiency (LFTs 3x greater than upper limit of normal; creatinine > 2 mg/dL)
  4. Thrombocytopenia (plt count < 75,000)
  5. History of intolerance to minocycline
  6. Baseline modified Rankin score > 1
  7. Stuporous or comatose (GCS < 8)
  8. Presence of concomitant serious illness that would confound study, including serious psychiatric disease or prior suicide attempts.
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Responsible Party: Jason Chang, Principal Investigator, University of Tennessee Health Science Center
ClinicalTrials.gov Identifier: NCT03040128    
Other Study ID Numbers: MITCH
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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