{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Tegtmeier F"],"funding":["National Institute for Health Research (NIHR)","vasopharm GmbH"],"pagination":["80"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6961322"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["21(1)"],"pubmed_abstract":["<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 insertion"],"journal":["Trials"],"pubmed_title":["Efficacy 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."],"pmcid":["PMC6961322"],"funding_grant_id":["NIHR200248","n.a."],"pubmed_authors":["LeFrant JY","Sahuquillo J","Fluh C","Bulters D","Tegtmeier F","Schmutzhard E","Lagares A","NOSTRA Investigators","Willschke H","Andrews P","Ibanez J","Schinzel R","Beer R","Unterberg A","Belli A","Mokry M"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy 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.","description":"<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 insertion","dates":{"release":"2020-01-01T00:00:00Z","publication":"2020 Jan","modification":"2026-04-29T16:03:48.174Z","creation":"2020-05-22T08:42:14Z"},"accession":"S-EPMC6961322","cross_references":{"pubmed":["31937347"],"doi":["10.1186/s13063-019-3965-4"]}}