A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients (MACH)
|ClinicalTrials.gov Identifier: NCT01805895|
Recruitment Status : Completed
First Posted : March 6, 2013
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage||Drug: Minocycline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Minocycline in Acute Cerebral Hemorrhage (MACH) Trial|
|Actual Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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 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.
Other Name: Dynacin, Minocin
No Intervention: Control
This arm will not receive any minocycline. This arm will receive standard of care treatment.
- Modified Rankin Scale [ Time Frame: 90 days ]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.
- Safety Assessment [ Time Frame: 90 days ]Adverse events will be asses for 90 days. This will serve as our safety endpoint.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805895
|United States, Georgia|
|Georgia Health Sciences University|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Jeffrey A Switzer, DO||Augusta University|