Translational Science & Intelligence, Grünenthal GmbH, Aachen, Germany.ģ.
Institute of Neuroscience (IoNS), UCLouvain, Brussels, Belgium.Ģ. Troconiz 13, Hans Van Niel 14, Jose Miguel Vela 15, Katy Vincent 16, Jan Vollert 17, Vishvarani Wanigasekera 12, Matthias Wittayer 4, Keith G Phillips 5*, Rolf-Detlef Treede 4*ġ. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA.Īndré Mouraux 1, Petra Bloms-Funke 2, Irmgard Boesl 3, Ombretta Caspani 4, Sonya C Chapman 5, Giulia Di Stefano 6, Nanna Brix Finnerup 7, Luis Garcia-Larrea 8, Marcus Goetz 9, Anna Kostenko 4, Bernhard Pelz 9, Esther Pogatzki-Zahn 10, Karin Schubart 11, Alexandre Stouffs 1, Andrea Truini 6, Irene Tracey 12, Iñaki F. This project has received funding from the Innovative Medicines Initiative 2 Joint undertaking under grant agreement No 777500.
#Rct3 ctr top spin trial#
IMI2-PainCare-BioPain-RCT3: A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by electro-encephalography (EEG) Complex statistical analyses and PK-PD modeling are exploratory. Remaining treatment arm effects on LEP or PEP or effects on EEG are key secondary confirmatory analyses. A sequentially rejective multiple testing approach will be used with overall alpha error of the primary analysis split between LEP and PEP under tapentadol.
Patient-reported outcomes will also be collected. Medication effects will be assessed concurrently in a non-sensitized normal condition and a clinically relevant hyperalgesic condition (high-frequency electrical stimulation of the skin). Biomarkers derived from scalp EEG measurements (laser-evoked brain potentials, pinprick-evoked brain potentials, resting EEG) will be obtained before and three times after administration of three medications known to act on the nociceptive system (lacosamide, pregabalin, tapentadol) and placebo, given as a single oral dose in separate study periods. This is a multisite single-dose, double-blind, randomized, placebo-controlled, 4-period, 4-way crossover, pharmacodynamic (PD) and pharmacokinetic (PK) study in healthy subjects. The Creative Commons Public Domain Dedication waiver ( ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
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