A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients "MACH"

Recruiting

Phase 1/2 Results N/A

Trial Description

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 Description

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.

Conditions

Interventions

  • Minocycline (Minocycline hydrochloride)Drug
    Other Names: Minocin; Minomycin; Akamin
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Minocycline
    Description: 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.
  • Minocyline Drug
    ARM 1: Kind: Experimental
    Label: Minocycline
    Description: This arm will receive a total of 5 doses of minocycline. There will be 1 dose of intravenous minocycline followed by 4 doses of oral (pill) minocycline. Each dose is 24 hours apart.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin Scale 90 days No
Primary Safety assessment 90 days Yes

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