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. |
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| 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 |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1745-6215 |
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| DOI: | 10.1186/s13063-022-06431-5 |
