Completed

MACHMinocycline in Acute Cerebral Hemorrhage (MACH) Trial

What is being tested

Minocycline

Drug

Who is being recruted

Brain Diseases+10

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 18 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: February 2013

See protocol details

Summary

Principal SponsorAugusta University

Last updated: April 26, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01805895

Principal SponsorAugusta University

Last updated: April 26, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesIntracranial HemorrhagesHemorrhagic StrokeCerebral HemorrhageHemorrhageStroke

Criteria

3 inclusion criteria required to participate

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

13 exclusion criteria prevent from participating

Allergy to tetracycline antibiotics

Glasgow Coma Scale score of 5 or less

Hepatic and/or renal insufficiency (LFT's > 3x upper limit of normal; Creatinine > 2mg/dL)

History of intolerance to minocycline

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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 II

No Intervention

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Georgia Health Sciences University

Augusta, United StatesOpen Georgia Health Sciences University in Google Maps

CompletedOne Study Center