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IMI2-PainCare-BioPain-RCT1: study protocol for a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by peripheral nerve excitability testing (NET).

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Title: IMI2-PainCare-BioPain-RCT1: study protocol for a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by peripheral nerve excitability testing (NET).
Authors: Nochi Z; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Pia H; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Bloms-Funke P; Translational Science & Intelligence, Grünenthal GmbH, Aachen, Germany., Boesl I; Clinical Science Development, Grünenthal GmbH, Aachen, Germany., Caspani O; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany., Chapman SC; Eli Lilly and Company, Arlington Square, Bracknell, UK., Fardo F; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Genser B; Mannheim Institute of Public Health, Social & Preventive Medicine, University of Heidelberg, Heidelberg, Germany., Goetz M; MRC Systems GmbH, Heidelberg, Germany., Kostenko AV; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany., Leone C; Department of Human Neuroscience, Sapienza University, Rome, Italy., Li T; Teva Branded Pharmaceutical Products R&D, Inc, West Chester, PA, USA., Mouraux A; Institute of Neuroscience (IoNS), UCLouvain, Brussels, Belgium., Pelz B; MRC Systems GmbH, Heidelberg, Germany., Pogatzki-Zahn E; Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany., Schilder A; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany., Schnetter E; University Computing Centre, University of Heidelberg, Heidelberg, Germany., Schubart K; ConsulTech GmbH, Berlin, Germany., Stouffs A; Institute of Neuroscience (IoNS), UCLouvain, Brussels, Belgium., Tracey I; Wellcome Centre for Integrative Neuroimaging, FMRIB Centre, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, OX3 9DU, UK., Troconiz IF; Department of Pharmaceutical Technology and Chemistry, School of Pharmacy and Nutrition, University of Navarra, Pamplona, Spain., Truini A; Department of Human Neuroscience, Sapienza University, Rome, Italy., Van Niel J; Mature Products Development, Grünenthal GmbH, Aachen, Germany., Vela JM; Welab Barcelona, Barcelona, Spain., Vincent K; Nuffield Department of Women's and Reproductive Health (NDWRH), University of Oxford, Oxford, UK., Vollert J; Pain Research, Department of Surgery and Cancer, Imperial College London, London, UK., Wanigasekera V; Wellcome Centre for Integrative Neuroimaging, FMRIB Centre, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, OX3 9DU, UK., Wittayer M; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany., Tankisi H; Department of Clinical Medicine, Aarhus University and Department of Clinical Neurophysiology, Aarhus University Hospital, Aarhus, Denmark., Finnerup NB; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. finnerup@clin.au.dk., Phillips KG; Neuroscience Next Generation Therapeutics, Eli Lilly and Company, Lilly Innovation Center, Cambridge, MA, USA., Treede RD; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany.
Source: Trials [Trials] 2022 Feb 19; Vol. 23 (1), pp. 163. Date of Electronic Publication: 2022 Feb 19.
Publication Type: Clinical Trial Protocol; Journal Article
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
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  Data: IMI2-PainCare-BioPain-RCT1: study protocol for a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by peripheral nerve excitability testing (NET).
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  Data: <searchLink fieldCode="AU" term="%22Nochi+Z%22">Nochi Z</searchLink>; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.<br /><searchLink fieldCode="AU" term="%22Pia+H%22">Pia H</searchLink>; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.<br /><searchLink fieldCode="AU" term="%22Bloms-Funke+P%22">Bloms-Funke P</searchLink>; Translational Science & Intelligence, Grünenthal GmbH, Aachen, Germany.<br /><searchLink fieldCode="AU" term="%22Boesl+I%22">Boesl I</searchLink>; Clinical Science Development, Grünenthal GmbH, Aachen, Germany.<br /><searchLink fieldCode="AU" term="%22Caspani+O%22">Caspani O</searchLink>; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany.<br /><searchLink fieldCode="AU" term="%22Chapman+SC%22">Chapman SC</searchLink>; Eli Lilly and Company, Arlington Square, Bracknell, UK.<br /><searchLink fieldCode="AU" term="%22Fardo+F%22">Fardo F</searchLink>; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.<br /><searchLink fieldCode="AU" term="%22Genser+B%22">Genser B</searchLink>; Mannheim Institute of Public Health, Social & Preventive Medicine, University of Heidelberg, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Goetz+M%22">Goetz M</searchLink>; MRC Systems GmbH, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Kostenko+AV%22">Kostenko AV</searchLink>; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany.<br /><searchLink fieldCode="AU" term="%22Leone+C%22">Leone C</searchLink>; Department of Human Neuroscience, Sapienza University, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Li+T%22">Li T</searchLink>; Teva Branded Pharmaceutical Products R&D, Inc, West Chester, PA, USA.<br /><searchLink fieldCode="AU" term="%22Mouraux+A%22">Mouraux A</searchLink>; Institute of Neuroscience (IoNS), UCLouvain, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Pelz+B%22">Pelz B</searchLink>; MRC Systems GmbH, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Pogatzki-Zahn+E%22">Pogatzki-Zahn E</searchLink>; Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany.<br /><searchLink fieldCode="AU" term="%22Schilder+A%22">Schilder A</searchLink>; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany.<br /><searchLink fieldCode="AU" term="%22Schnetter+E%22">Schnetter E</searchLink>; University Computing Centre, University of Heidelberg, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Schubart+K%22">Schubart K</searchLink>; ConsulTech GmbH, Berlin, Germany.<br /><searchLink fieldCode="AU" term="%22Stouffs+A%22">Stouffs A</searchLink>; Institute of Neuroscience (IoNS), UCLouvain, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Tracey+I%22">Tracey I</searchLink>; Wellcome Centre for Integrative Neuroimaging, FMRIB Centre, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, OX3 9DU, UK.<br /><searchLink fieldCode="AU" term="%22Troconiz+IF%22">Troconiz IF</searchLink>; Department of Pharmaceutical Technology and Chemistry, School of Pharmacy and Nutrition, University of Navarra, Pamplona, Spain.<br /><searchLink fieldCode="AU" term="%22Truini+A%22">Truini A</searchLink>; Department of Human Neuroscience, Sapienza University, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Van+Niel+J%22">Van Niel J</searchLink>; Mature Products Development, Grünenthal GmbH, Aachen, Germany.<br /><searchLink fieldCode="AU" term="%22Vela+JM%22">Vela JM</searchLink>; Welab Barcelona, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Vincent+K%22">Vincent K</searchLink>; Nuffield Department of Women's and Reproductive Health (NDWRH), University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Vollert+J%22">Vollert J</searchLink>; Pain Research, Department of Surgery and Cancer, Imperial College London, London, UK.<br /><searchLink fieldCode="AU" term="%22Wanigasekera+V%22">Wanigasekera V</searchLink>; Wellcome Centre for Integrative Neuroimaging, FMRIB Centre, Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford, OX3 9DU, UK.<br /><searchLink fieldCode="AU" term="%22Wittayer+M%22">Wittayer M</searchLink>; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany.<br /><searchLink fieldCode="AU" term="%22Tankisi+H%22">Tankisi H</searchLink>; Department of Clinical Medicine, Aarhus University and Department of Clinical Neurophysiology, Aarhus University Hospital, Aarhus, Denmark.<br /><searchLink fieldCode="AU" term="%22Finnerup+NB%22">Finnerup NB</searchLink>; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. finnerup@clin.au.dk.<br /><searchLink fieldCode="AU" term="%22Phillips+KG%22">Phillips KG</searchLink>; Neuroscience Next Generation Therapeutics, Eli Lilly and Company, Lilly Innovation Center, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Treede+RD%22">Treede RD</searchLink>; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), University of Heidelberg, Mannheim, Germany.
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  Data: <searchLink fieldCode="JN" term="%22101263253%22">Trials</searchLink> [Trials] 2022 Feb 19; Vol. 23 (1), pp. 163. <i>Date of Electronic Publication: </i>2022 Feb 19.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BioMed+Central%22">BioMed Central </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101263253 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1745-6215 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2217456215%22">17456215 </searchLink><i>NLM ISO Abbreviation: </i>Trials <i>Subsets: </i>MEDLINE
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