biostudies-literatureTegtmeier FNational Institute for Health Research (NIHR)vasopharm GmbH80https://www.ebi.ac.uk/biostudies/studies/S-EPMC6961322biostudies-literatureUnknown21(1)<h4>Background</h4>Traumatic brain injury is a leading cause of death and disability worldwide. The nitric oxide synthase inhibitor Ronopterin was shown to improve clinical outcome by enhancing neuroprotection in a phase IIa trial.<h4>Methods/design</h4>The NOSTRA phase III trial (Ronopterin in traumatic brain injury) is a multi-centre, prospective, randomised, double-blinded, placebo-controlled, phase III trial in Europe. It aims at determining whether the administration of Ronopterin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at 6 months after injury. The trial is designed to recruit patients between 18 and 60 years of age with moderate or severe traumatic brain injury (Glasgow Coma Scale score ≥ 3) and requiring insertionTrialsEfficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study.PMC6961322NIHR200248n.a.LeFrant JYSahuquillo JFluh CBulters DTegtmeier FSchmutzhard ELagares ANOSTRA InvestigatorsWillschke HAndrews PIbanez JSchinzel RBeer RUnterberg ABelli AMokry MfalseEfficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study.<h4>Background</h4>Traumatic brain injury is a leading cause of death and disability worldwide. The nitric oxide synthase inhibitor Ronopterin was shown to improve clinical outcome by enhancing neuroprotection in a phase IIa trial.<h4>Methods/design</h4>The NOSTRA phase III trial (Ronopterin in traumatic brain injury) is a multi-centre, prospective, randomised, double-blinded, placebo-controlled, phase III trial in Europe. It aims at determining whether the administration of Ronopterin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at 6 months after injury. The trial is designed to recruit patients between 18 and 60 years of age with moderate or severe traumatic brain injury (Glasgow Coma Scale score ≥ 3) and requiring insertion2020-01-01T00:00:00Z2020 Jan2026-04-29T16:03:48.174Z2020-05-22T08:42:14ZS-EPMC69613223193734710.1186/s13063-019-3965-4