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Table 4 Primary and key secondary endpoints

From: IMI2-PainCare-BioPain-RCT3: 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 electroencephalography (EEG)

Primary endpoints:

1. To test if the percentage reduction of LEP amplitude 60 min post-drug administration differs in the tapentadol period as compared to the placebo period, at the non-sensitized forearm.

2. To test if the percentage reduction of PEP amplitude 60 min post-drug administration differs in the tapentadol period as compared to the placebo period, at the sensitized forearm.

Key secondary analyses of the primary endpoints:

1. To test if the percentage reduction of LEP amplitude 60 min post-drug administration differs in the pregabalin and/or lacosamide periods as compared to the placebo period, at the non-sensitized forearm.

2. To test if the percentage reduction of PEP amplitude 60 min post-drug administration differs in the pregabalin and/or lacosamide periods as compared to the placebo period, at the sensitized forearm.

3. To test if the percentage change in magnitude of theta oscillations 60 min post-drug administration differs in the tapentadol, pregabalin, and/or lacosamide periods as compared to the placebo period.