A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients (MACH)
|ClinicalTrials.gov Identifier: NCT01805895|
Recruitment Status : Unknown
Verified February 2016 by Jeffrey Switzer, Georgia Regents University.
Recruitment status was: Recruiting
First Posted : March 6, 2013
Last Update Posted : February 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage||Drug: Minocycline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Minocycline in Acute Cerebral Hemorrhage (MACH) Trial|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||March 2017|
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 after 90 days to determine functional outcome. This will serve as our efficacy endpoint.
- 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
|Contact: Jeffrey A Switzer, DOemail@example.com|
|Contact: Mary Anne Park, RNfirstname.lastname@example.org|
|United States, Georgia|
|Georgia Health Sciences University||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Jeffrey Switzer, DO 706-721-1691 email@example.com|
|Principal Investigator: Jeffrey Switzer, DO|
|Sub-Investigator: David Hess, MD|
|Sub-Investigator: Askiel Bruno, MD|
|Sub-Investigator: Fenwick Nichols, MD|
|Sub-Investigator: Hartmut Gross, MD|
|Sub-Investigator: Susan Fagan, PharmD|
|Principal Investigator:||Jeffrey A Switzer, DO||Augusta University|