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IMI2-PainCare-BioPain-RCT2 protocol: a randomized, double-blind, placebo-controlled, crossover, multicenter trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by non-invasive neurophysiological measurements of human spinal cord and brainstem activity.

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Title: IMI2-PainCare-BioPain-RCT2 protocol: a randomized, double-blind, placebo-controlled, crossover, multicenter trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by non-invasive neurophysiological measurements of human spinal cord and brainstem activity.
Authors: Leone C; Department of Human Neuroscience, Sapienza University, Rome, Italy. caterinamaria.leone@gmail.com., Di Stefano G; Department of Human Neuroscience, Sapienza University, Rome, Italy., Di Pietro G; Department of Human Neuroscience, Sapienza University, Rome, Italy., 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), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany., Chapman SC; Neuroscience Next Generation Therapeutics, Eli Lilly and Company, Lilly Innovation Center, Cambridge, MA, USA.; Eli Lilly and Company, Arlington Square, Bracknell, UK., Finnerup NB; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Garcia-Larrea L; Lyon Neurosciences Center Research Unit Inserm U 1028, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Lyon 1 University, Lyon, France., Li T; Teva Pharmaceutical Industries Ltd., Petah Tikva, Israel., Goetz M; MRC Systems GmbH, Heidelberg, Germany., 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), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany., Schnetter E; University Computing Centre, University of Heidelberg, Heidelberg, Germany., Schubart K; ConsulTech GmbH, Berlin, Germany., Tracey I; Wellcome Centre for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK., Troconiz IF; Department of Pharmaceutical Technology and Chemistry, School of Pharmacy and Nutrition, University of Navarra, Pamplona, Spain., Van Niel H; Mature Products Development, Grünenthal GmbH, Aachen, Germany., Hernandez JMV; Welab Barcelona, Barcelona, Spain.; Drug Discovery & Preclinical Development, ESTEVE Pharmaceuticals, Barcelona, Spain., Vincent K; Nuffield Department of Women's and Reproductive Health (NDWRH), University of Oxford, Oxford, UK., Vollert J; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.; Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany.; Pain Research, Department of Surgery and Cancer, Imperial College London, London, UK., Wanigasekera V; Wellcome Centre for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK., Wittayer M; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany., Phillips KG; Neuroscience Next Generation Therapeutics, Eli Lilly and Company, Lilly Innovation Center, Cambridge, MA, USA.; Eli Lilly and Company, Arlington Square, Bracknell, UK., Truini A; Department of Human Neuroscience, Sapienza University, Rome, Italy., Treede RD; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Source: Trials [Trials] 2022 Sep 05; Vol. 23 (1), pp. 739. Date of Electronic Publication: 2022 Sep 05.
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-RCT2 protocol: a randomized, double-blind, placebo-controlled, crossover, multicenter trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by non-invasive neurophysiological measurements of human spinal cord and brainstem activity.
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  Data: <searchLink fieldCode="AU" term="%22Leone+C%22">Leone C</searchLink>; Department of Human Neuroscience, Sapienza University, Rome, Italy. caterinamaria.leone@gmail.com.<br /><searchLink fieldCode="AU" term="%22Di+Stefano+G%22">Di Stefano G</searchLink>; Department of Human Neuroscience, Sapienza University, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Di+Pietro+G%22">Di Pietro G</searchLink>; Department of Human Neuroscience, Sapienza University, Rome, Italy.<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), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.<br /><searchLink fieldCode="AU" term="%22Chapman+SC%22">Chapman SC</searchLink>; Neuroscience Next Generation Therapeutics, Eli Lilly and Company, Lilly Innovation Center, Cambridge, MA, USA.; Eli Lilly and Company, Arlington Square, Bracknell, UK.<br /><searchLink fieldCode="AU" term="%22Finnerup+NB%22">Finnerup NB</searchLink>; Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.<br /><searchLink fieldCode="AU" term="%22Garcia-Larrea+L%22">Garcia-Larrea L</searchLink>; Lyon Neurosciences Center Research Unit Inserm U 1028, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Lyon 1 University, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Li+T%22">Li T</searchLink>; Teva Pharmaceutical Industries Ltd., Petah Tikva, Israel.<br /><searchLink fieldCode="AU" term="%22Goetz+M%22">Goetz M</searchLink>; MRC Systems GmbH, Heidelberg, Germany.<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), Medical Faculty Mannheim, 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="%22Tracey+I%22">Tracey I</searchLink>; Wellcome Centre for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, 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="%22Van+Niel+H%22">Van Niel H</searchLink>; Mature Products Development, Grünenthal GmbH, Aachen, Germany.<br /><searchLink fieldCode="AU" term="%22Hernandez+JMV%22">Hernandez JMV</searchLink>; Welab Barcelona, Barcelona, Spain.; Drug Discovery & Preclinical Development, ESTEVE Pharmaceuticals, 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>; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.; Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany.; 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, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.<br /><searchLink fieldCode="AU" term="%22Wittayer+M%22">Wittayer M</searchLink>; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.<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.; Eli Lilly and Company, Arlington Square, Bracknell, UK.<br /><searchLink fieldCode="AU" term="%22Truini+A%22">Truini A</searchLink>; Department of Human Neuroscience, Sapienza University, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Treede+RD%22">Treede RD</searchLink>; Department of Neurophysiology, Mannheim Center for Translational Neurosciences (MCTN), Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
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