Caterina Leone, Giulia Di Stefano, Giuseppe Di Pietro, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C Chapman, Nanna Brix Finnerup, Luis Garcia-Larrea, Tom Li, Marcus Goetz, André Mouraux, Bernhard Pelz, Esther Pogatzki-Zahn, Andreas Schilder, Erik Schnetter, Karin Schubart, Irene Tracey, Inaki F Troconiz, Hans Van Niel, Jose Miguel Vela Hernandez, Katy Vincent, Jan Vollert, Vishvarani Wanigasekera, Matthias Wittayer, Keith G Phillips, Andrea Truini, Rolf-Detlef Treede
BACKGROUND: IMI2-PainCare-BioPain-RCT2 is one of four similarly designed clinical studies aiming at profiling a set of functional biomarkers of drug effects on specific compartments of the nociceptive system that could serve to accelerate the future development of analgesics. IMI2-PainCare-BioPain-RCT2 will focus on human spinal cord and brainstem activity using biomarkers derived from non-invasive neurophysiological measurements. METHODS: 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...
September 5, 2022: Trials