drugset / Trial / NCT01058395

Safety and Feasibility of Minocycline in the Treatment of Traumatic Brain Injury (TBI)

NCT01058395

Phase 1/2 Completed 15 enrolled Wayne State University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-02
Primary completion
2015-09
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Minocycline Small molecule 200 mg Intravenous
Subject Minocycline Small molecule 400 mg Intravenous