A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Intracerebral Hemorrhage Clinical Trial

— MACH  

Official title:

Minocycline in Acute Cerebral Hemorrhage (MACH) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805895
• Other study ID #: Pro00000718
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 5, 2013
• Last updated: March 28, 2018
• Start date: February 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Georgia Health Sciences University	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	Safety Assessment	Adverse events will be asses for 90 days. This will serve as our safety endpoint.	90 days