A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Minocycline

This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.

Intervention Type DRUG

Other Intervention Names

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Dynacin, Minocin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No