Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke "MINOS"

Completed

Phase 1/2 Results

Trial Description

The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.

Detailed Description

Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration (FDA) for treatment of infections and acne. However, doctors do not know whether minocycline will work in stroke patients. Its use in stroke patients is experimental. There is a lot of information from experimental stroke studies in animals that minocycline lessens the damage from a stroke and the animals recover better. Since minocycline is generally a very safe drug in humans and does not have a lot of side effects, investigators at Georgia Health Sciences University (formerly the Medical College of Georgia) believe that it might be a safe and effective drug to improve the outcome in patients with stroke.

Conditions

Interventions

  • Minocycline (Minocycline hydrochloride)Drug
    Other Names: MinocinĀ®
    Intervention Desc: Dose level 1 = 3mg/kg intravenous (IV) initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses. Dose level 2 = 4.5mg/kg intravenous (IV) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses. Dose level 3 = 6 mg/kg intravenous (IV) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses. Dose level 4 = 10 mg/kg intravenous (IV) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Patient Involvement

Dose assignments will be increased as each tier is completed and determined to be safe. Dose level 1 = 3mg/kg IV(intravenous)initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses; Dose level 2 = 4.5mg/kg IV(intravenous) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses; Dose level 3 = 6 mg/kg IV(intravenous) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses;Dose level 4 = 10 mg/kg IV (intravenous) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses.

Outcomes

Type Measure Time Frame Safety Issue
Primary Adverse events such as intracranial hemorrhage, allergic reactions, and other reported events will be assessed at regular intervals throughout the study period
Secondary Determine the pharmacokinetics of Minocycline in patients with ischemic stroke; determine the effect of the different doses of MC on plasma MMP-9 activity; gather preliminary data of the effect of different doses of MC on functional outcome.
Primary The objective of this project is to determine the maximally tolerated intravenous dose of minocycline in ischemic stroke patients. 18 months Yes
Secondary Determine the pharmacokinetics of Minocycline in patients with ischemic stroke 18 months No
Secondary Determine the effect of the different doses of MC on plasma MMP-9 activity. 2 years No
Secondary Gather preliminary data of the effect of different doses of MC on functional outcome 2 years No
Primary Maximally Tolerated Dose of IV Minocycline 3 days Yes
Secondary Half-life of IV Minocycline For each subject blood samples were drawn before dose #1 and one hour after starting dose #1. Additional blood was drawn 1, 6, 12, 24, 48, and 72 hours after starting dose #6, which lasted approximately 6 days. No
Secondary 90 Day Modified Rankin Scale Score 3 months No

Sponsors