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

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

Outcome

Met primary endpoint

registry analysis (superiority test); 800 mg Loading Then 200 mg Q12 vs 800 mg Loading Then 400 mg Q12; p = 0.021; ANCOVA; note: P-value NCT01058395 ↗

Publications

Meythaler J, Fath J, Fuerst D, Zokary H, Freese K, Martin HB, Reineke J, Peduzzi-Nelson J, Roskos PT. Safety and feasibility of minocycline in treatment of acute traumatic brain injury. Brain Inj. 2019;33(5):679-689. doi: 10.1080/02699052.2019.1566968. Epub 2019 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Minocycline	Small molecule	200 mg	Intravenous
Subject	Minocycline	Small molecule	400 mg	Intravenous