Traumatic Brain Injury Clinical Trial
Official title:
Phase I Study of Minocycline in a Dose Escalation Study as a Safe, Efficacious Therapeutic Intervention for Moderate and Severe TBI in Humans
The purpose of this study is:
1. To assess the safety and feasibility of minocycline administration after TBI in a dose
escalation study at two different doses over 7 days.
2. To assess the pharmacokinetic characteristics of two different dosing regimens of
minocycline in TBI patients, the effect on biochemical markers of neuroprotective
mechanisms, and effect on neurobehavioral and functional outcome.
3. To begin initial assessment of the efficacy of minocycline as a therapeutic agent for
severe human TBI.
The purpose of this preliminary study is to test the hypothesis that administration of
minocycline to humans with moderate and severe TBI is both safe and feasible in the acute
post-injury setting, and to characterize its disposition and effects on biomarkers of
traumatic CNS injury in a Phase IIa trial. The data collected will serve as the basis for a
larger Phase IIb clinical trial in a randomized placebo-controlled parallel group design, to
investigate further its potential safety and efficacy as a therapeutic agent for severe human
TBI.
Tetracycline derivatives, including doxycycline and minocycline, have been shown to be
neuroprotective when given after traumatic brain injury (TBI) and ischemia in rodents. In
particular, reduced lesion volume and improved neurological outcome have been demonstrated
following minocycline treatment of TBI. The proposed mechanism for these observations is
multifactorial, and includes inhibition of microglial activation, caspase-mediated apoptosis,
and the excitotoxic N-methyl-D-aspartic acid (NMDA) pathway. Because comparable inflammatory,
excitotoxic and apoptotic pathways have also been implicated in human TBI, we hypothesize
that administration of minocycline will confer neuroprotection after moderate to severe TBI
in that milieu as well, with the potential for significant clinical benefit. Minocycline is
highly lipophilic, and thus penetrates the human central nervous system (CNS). In addition,
it has been shown to be safe when used in non-traumatic human neurological disorders.
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