drugset / Trial / NCT01058395
Safety and Feasibility of Minocycline in the Treatment of Traumatic Brain Injury (TBI)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Minocycline | Small molecule | 200 mg | Intravenous |
| Subject | Minocycline | Small molecule | 400 mg | Intravenous |