2. Academic Validation
  3. 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

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

  • Trials. 2020 Jan 14;21(1):80. doi: 10.1186/s13063-019-3965-4.
Frank Tegtmeier 1,  Reinhard Schinzel 2,  Ronny Beer 3,  Diederik Bulters 4,  Jean-Yves LeFrant 5,  Joan Sahuquillo 6,  Andreas Unterberg 7,  Peter Andrews 8,  Antonio Belli 9,  Javier Ibanez 10,  Alfonso Lagares 11,  Michael Mokry 12,  Harald Willschke 13,  Charlotte Flüh 14,  Erich Schmutzhard 3,  NOSTRA Investigators
Affiliations

Affiliations

  • 1 vasopharm GmbH, Würzburg, Germany.
  • 2 vasopharm GmbH, Würzburg, Germany. schinzel@vasopharm.de.
  • 3 Medizinische Universität Innsbruck, Innsbruck, Austria.
  • 4 Wessex Neurological Centre University Hospital, Southampton, UK.
  • 5 Hopital Universitaire Caremeau , Nimes, France.
  • 6 Vall d'Hebron University Hospital , Barcelona, Spain.
  • 7 Universitätsklinikum Heidelberg, Heidelberg, Germany.
  • 8 Western General Hospital Lothian University , Edinburgh, UK.
  • 9 Queen Elizabeth Hospital, Birmingham, UK.
  • 10 Espases University Hospital , Palma de Mallorca, Spain.
  • 11 Hospital Universitario 12 de Octubre , Madrid, Spain.
  • 12 LKH - Universitätsklinikum Graz, Graz, Austria.
  • 13 Medizinische Universität Wien, Wien, Austria.
  • 14 Universitätsklinikum Schleswig-Holstein, Kiel, Germany.
PMID: 31937347 DOI: 10.1186/s13063-019-3965-4
Abstract

Background: 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.

Methods/design: 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 of an intracranial pressure probe. Trial patients will receive a 48-h intravenous infusion of either Ronopterin or placebo starting at the earliest 6 h and at the latest 18 h after injury. The primary outcome will be the extended Glasgow Outcome Score (eGOS) at 6 months. Secondary outcomes will include the Quality of Life Index (QOLIBRI) at 6 months after the injury and the eGOS at 3 months after the injury. Additionally, effects on mortality, intracranial pressure and cerebral perfusion pressure are evaluated.

Discussion: The trial aims to provide evidence on the efficacy and safety of Ronopterin in patients with traumatic brain injury.

Trial registration: EudraCT, 2013-003368-29. Registered on 9 March 2016. ClinicalTrials.gov, NCT02794168. Registered on 8 June 2016. Protocol version 14.0 from 05 November 2018.

Keywords

Nitric oxide synthase inhibition; Outcome; Randomised controlled trials; Traumatic brain injury.

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