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

Augusta University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Intracerebral Hemorrhage

Treatments: Drug: Minocycline

Study type: Interventional

Funder types: Other

Identifiers

NCT01805895

Pro00000718

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Minocycline

Experimental group

Description:

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.

Treatment:

Drug: Minocycline

Control

No Intervention group

Description:

This arm will not receive any minocycline. This arm will receive standard of care treatment.