Clinical trial NCT01805895: A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients
Official title: Minocycline in Acute Cerebral Hemorrhage (MACH) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: Stroke
Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage
Hemorrhagic stroke
Hemorrhage
Minocycline
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2013-03-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 90 days
Secondary outcomes:
measure: Safety Assessment
timeFrame: 90 days
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
Study officials:
affiliation: Augusta University
name: Jeffrey A Switzer, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.