Journal of neurotrauma
-
Journal of neurotrauma · Oct 2014
Randomized Controlled Trial Multicenter StudyNO-Synthase Inhibition with the Antipterin VAS203 improves Outcome in moderate and severe Traumatic Brain Injury: a Placebo-Controlled Randomised Phase II Trial (NOSTRA).
Traumatic brain injury (TBI) is an important cause of death and disability. Safety and pharmacodynamics of 4-amino-tetrahydrobiopterin (VAS203), a nitric oxide (NO)-synthase inhibitor, were assessed in TBI in an exploratory Phase IIa study (NOSynthase Inhibition in TRAumatic brain injury=NOSTRA). The study included 32 patients with TBI in six European centers. ⋯ At the highest dose administered, four of eight patients receiving VAS203 showed transitory acute kidney injury (stage 2-3). In conclusion, the significant improvement in clinical outcome indicates VAS203-mediated neuroprotection after TBI. At the highest dose, VAS203 is associated with a risk of acute kidney injury.