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)

Table 5 Detailed timetable of procedures and assessments in periods 1, 2, 3, and 4

Clock time	Time relative to dose (minutes)	Time relative to HFS (minutes)	Dose	HFS	PK	PD	Hyperalgesia testing**	PROMs	(D)rink (M)eal
08:00	− 150	− 60
08:30	− 120	− 30						X
09:00	− 90	0		X
09:30	− 60	30				[1]
10:00	− 30	60
10:30	0	90	X						D
11:00	30	120
11:15	45	135			[1]
11:30	60	150				[2]
12:00	90	180
12:30	120	210					X		D
13:00	150	240			[2]
13:30	180	270				[3]
14:00	210	300
14:30	240	330			[3]				M
15:00	270	360
15:30	300	390						X
16:00	330	420
16:30	360	450				[4]
17:00	390	480
17:30	420	510			[4]				D
18:00	450	540
Next day					(5)*

*The PK sample on next day can be taken at any suitable time provided that the exact time of sampling is precisely recorded. **Hyperalgesia testing at the sensitized and contralateral forearm, harmonized across all four IMI2-PainCare-BioPain RCTs. Reproduced from [2]

ISSN: 1745-6215