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

Primary Purpose

Intracerebral Hemorrhage

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Minocycline

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Stroke, Acute Intracerebral Hemorrhage, Intracerebral Hemorrhage, Hemorrhagic stroke, Hemorrhage, Minocycline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Georgia Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Minocycline

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

Modified Rankin Scale

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

Safety Assessment

Adverse events will be asses for 90 days. This will serve as our safety endpoint.

Full Information

NCT ID

NCT01805895

First Posted

March 5, 2013

Last Updated

March 28, 2018

Sponsor

Augusta University

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT01805895

Brief Title

A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Acronym

MACH

Official Title

Minocycline in Acute Cerebral Hemorrhage (MACH) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

February 2013 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Augusta University

Collaborators

American Heart Association

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracerebral Hemorrhage

Keywords

Stroke, Acute Intracerebral Hemorrhage, Intracerebral Hemorrhage, Hemorrhagic stroke, Hemorrhage, Minocycline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minocycline

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Minocycline

Other Intervention Name(s)

Dynacin, Minocin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Modified Rankin Scale

Description

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Safety Assessment

Description

Adverse events will be asses for 90 days. This will serve as our safety endpoint.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey A Switzer, DO

Organizational Affiliation

Augusta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgia Health Sciences University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28887388

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.

Results Reference

derived

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A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

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