Safety and Feasibility of Minocycline in the Treatment of TBI
Investigators: Jay Meythaler, MD; Denise Roney, PharmD; Scott Millis, PhD
This study is a drug trial designed to establish optimal dosage of minocycline given acutely following TBI. Reduced lesion volume and improved neurological outcome have been demonstrated following minocycline treatment of TBI. The purpose of this preliminary study is to test the hypothesis that administration of minocycline to humans with moderate and sever TBI is both safe and feasible in the acute post-injury setting, and to characterize its disposition and effects on biomarkers of traumatic Central Nervous System (CNS) injury in a Phase IIa trial. Participants will receive IV minocycline over 7 days during their acute care treatment. Follow-up data collection will occur at the end of the trial, during inpatient rehabilitation and three months post-injury. The study will gather preliminary functional outcome data in an attempt to conduct a clinical feasibility assessment with this drug.