Phase 2 N=16 Randomized Single-blind Treatment

A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Intracerebral Hemorrhage

Bottom Line

View on ClinicalTrials.gov: NCT01805895 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Modified Rankin Scale — 3.5; 3.7 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Minocycline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Augusta University
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Modified Rankin Scale	3.5; 3.7	—
SECONDARY Safety Assessment	0; 0	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01805895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.