Skip to main content

Table 1 Primary and key secondary objectives

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)

Co-primary objectives:

1. To test if the SDTC changes (at planned first post-dose timing) of large sensory fibers differ in the lacosamide period as compared to the placebo period.

2. To test if the SDTC changes (at planned first post-dose timing) of large motor fibers differs in the lacosamide period as compared to the placebo period.

Key secondary objectives:

1. To test if the SDTC changes (at planned first post-dose timing) of large sensory fibers differ in the pregabalin and/or tapentadol periods as compared to the placebo period.

2. To test if the SDTC changes (at planned first post-dose timing) of large motor fibers in the pregabalin and/or tapentadol periods differs as compared to the placebo period.

3. To test if the SDTC changes (at planned first post-dose timing) of small sensory fibers differ in the lacosamide period as compared to the placebo period.

Back to article page

Trials

ISSN: 1745-6215