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Table 2 Inclusion criteria at screening visit

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)

  Inclusion criteria at screening visit Justification / rationale
01 Provision of signed and dated informed consent form Ethical requirement
02 Stated willingness to comply with all study procedures and regimens and availability for the duration of the study Ethical requirement and to minimize dropout rate
03 Caucasian male or female subjects, aged 18 to 45 years To minimize variability. Laser heat stimuli used to elicit LEPs will be delivered to the skin using an Nd:YAP laser. Because skin reflectance, absorption and transmittance of the infrared radiations generated by this laser are highly dependent on skin pigmentation, only Caucasian participants with light skin will be recruited.
04 Subjects must be in good health as determined by the medical history, physical and laboratory examinations and must not show any clinically significant deviations from reference ranges as determined by 12-lead electrocardiogram (ECG), vital signs (blood pressure, pulse rate and respiratory rate) and laboratory parameters (renal and hepatic function). Subject safety and interpretability of results
05 Body mass index > 18 kg/m2 and <  30 kg/m2 with a minimum body weight of 45.0 kg and a maximum of 100 kg (for men and women) Consistent with being in good health
06 Ability to take oral medication Practical reason
07 For female subjects of childbearing potential: use of highly effective contraception with a low failure rate defined as < 1% per year for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration:
- combined (estrogen and progestogen containing) hormonal contraception,
- an intra-uterine device (hormone-free),
- progestogen-only hormonal contraception associated with inhibition of ovulation,
- an intra-uterine hormone releasing system (IUS)
A woman of non-childbearing potential may be included if surgically sterile (i.e., after laparoscopic or hysteroscopic sterilization, hysterectomy or bilateral oophorectomy) or post- menopausal for at least 2 years.
To avoid pregnancies with potential harm to the unborn
08 Right hand dominance (assessed using the Edinburgh Handedness Inventory, and defined as a score ≥ 60) To minimize variability