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Fig. 1 | Trials

Fig. 1

From: 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)

Fig. 1

Trial design of each study period. After HFS, NET will be performed four times as indicated in light red. After the first test, the drug will be administered. Five blood samples will be taken to measure plasma drug levels (indicated by PK) and to model the PK profiles in the plasma (P), peripheral nerves (N), spinal (S), and brain (B) compartments. Patient-reported outcomes will be used to assess the subject’s expectations of pain, anxiety and pain relief (expectation PROMs), and tiredness and state anxiety (state PROMs). Assessment of hyperalgesia will be done once (light blue). Reproduced from [2]

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Trials

ISSN: 1745-6215