Clinical Trial: A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Minocycline in Acute Cerebral Hemorrhage (MACH) Trial

Brief 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.

Detailed Summary: 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.
Sponsor: Augusta University

Current Primary Outcome: 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.


Original Primary Outcome:

  • 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 assessed for 90 days. This will serve as our safety endpoint.


Current Secondary Outcome: Safety Assessment [ Time Frame: 90 days ]

Adverse events will be asses for 90 days. This will serve as our safety endpoint.


Original Secondary Outcome:

Information By: Augusta University

Dates:
Date Received: March 5, 2013
Date Started: February 2013
Date Completion: March 2017
Last Updated: February 9, 2016
Last Verified: February 2016