A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Phase 1

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Minocycline	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.

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale	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