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Table 3 Exclusion 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)

  Exclusion criteria at screening visit Justification / rationale
01 Presence of any medical devices (e.g., cardiac pacemaker), implants or prothesis unless it is beyond discussion that these will not put the subject’s safety during the study at risk and will not interfere with the results of the study. To avoid interference with the purpose of the study and to ascertain the subject’s good health
02 Known or suspected allergic reactions or hypersensitivity to components of lacosamide (Vimpat®). Second or third degree atrioventricular (AV) block. Contraindications for lacosamide
03 Known or suspected allergic reactions or hypersensitivity to components of pregabalin (Lyrica®). Contraindications for pregabalin
04 Known or suspected allergic reactions or hypersensitivity to components of tapentadol (Palexia®). Known contraindication for drugs with μ-opioid agonist activity, i.e., significant respiratory depression, acute or severe bronchial asthma or hypercapnia. Present or suspected paralytic ileus. Acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs. Contraindications for tapentadol
05 Not willing or able to abstain from changes in physical exercise activities during the Study. To avoid interference with the purpose of the study
06 Any chronic pain condition or recent (i.e., within the preceding 2 years) history thereof. To avoid interference with the purpose of the study
07 Migraine (at least 1 attack in the last 24 months) To avoid interference with the purpose of the study
08 Recurrent headache or back pain on more than 5 days/month in the last 3 months To avoid interference with the purpose of the study
09 Caffeine consumption of more than 8 servings of coffee, tea, or other caffeinated drinks per day. Each serving is approximately 120 mg of caffeine To avoid interference with the purpose of the study
10 Any relevant symptom of neurological dysfunction of the motor and sensory system that may interfere with the conduct of the study. To avoid interference with the purpose of the study
11 Clinically evident psychiatric diseases (e.g., depression, anxiety). To avoid interference with the purpose of the study
12 History or symptoms of central nervous system disease or peripheral nerve lesions or dysfunction with sequelae that may impact the study assessments or that may deteriorate by one dose of a drug with antiepileptic, noradrenergic or opioid activity. To avoid interference with the purpose of the study
Subject safety
13 Focused neurological examination showing signs of abnormality. To avoid interference with the purpose of the study
14 Active internal disease or sequelae of internal disease (e.g., diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases, hypo- or hyperthyroidism, hypertension). To ascertain the subject’s good health
15 Diseases or conditions known to interfere with the distribution, metabolism, or excretion of drugs. To avoid artifacts
16 Clinically significant disease (e.g., medical history of infection with human immunodeficiency virus (HIV) type 1 or type 2, hepatitis B, or hepatitis C) or condition that may affect efficacy or safety assessments, or any other reasons which, in investigator’s opinion, may preclude the subject’s participation in the trial. Safety of investigator and their staff
Standardization of the trial population
17 Not willing or able to abstain from alcohol from 48 h prior to any study period and until the end of the study period. To ascertain and protect the subject’s good health and suitability for the study
18 Consumption of cannabis in the last 4 weeks prior to the study. To ascertain and protect the subject’s good health and suitability for the study
19 Evidence or history of alcohol or drug (opioids, amphetamines, benzodiazepines cannabinoids) abuse (as defined by ICD-10 or DSM IV) including positive or missing drugs of abuse screen (urine drugs of abuse test). Consumption of more than 21 alcohol units per week for male subjects and more than 14 units per week for female subjects (1 alcohol unit = 1 beer [12 oz/355 mL] = 1 wine [5 oz/150 mL] = 1 liquor [1.5 oz/40 mL] = 0.75 oz/20 mL alcohol). To ascertain and protect the subject’s good health and suitability for the study
20 Habitually smoking more than 10 cigarettes, 2 cigars, or 2 pipes of tobacco per day within the last 6 months before enrollment in this trial. To ascertain the subject’s good health
21 Known or suspected of not being willing or able to comply with the requirements of the trial protocol or the instructions. To ascertain the subject’s suitability for the study
22 Inability to communicate meaningfully with the trial site staff (e.g., insufficient language skills). To ascertain the subject´s safety
23 Any person with direct involvement in the trial conduct; any person under the direct supervision of the investigator or dependent on the investigator. Ethical requirement
24 Blood loss of 500 mL or more (e.g., owing to blood donation) within 3 months before enrollment in this trial. To ascertain the subject’s suitability for the study
25 Pregnancy, planned pregnancy or lactation. Ethical requirement to protect the unborn or newborn child
26 Presence of dermatological conditions in the test areas of the study that would prevent the proper application of study procedures, such as electrodes for HFS, pinprick (dermatitis, psoriasis, contact eczema, local changes of the skin due to regularly playing volleyball, etc.). To avoid interference with the purpose of the study
27 Any other reason to exclude the subject according to judgment by the investigator To avoid interference with the purpose of the study.
A set of temporary exclusion criteria have also been defined. The subject will not be excluded if some of these temporary exclusion criteria are met during the screening visit. Instead, the first study period may be postponed. Before the start of the first study period, previously met temporary exclusion criteria will be checked again, and their absence will be verified before the screening for the first study period takes place.
28 Any drug intake in the past 2 weeks including antibiotics, herbal medicines and other remedies except the following allowed drugs: oral paracetamol or ibuprofen for a self-limiting condition (e.g., toothache, bruise) for up to 3 days in total within the past 2 weeks; oral antihistaminics and nasal aerosol and topical treatments for seasonal allergy up to 1 week before screening; contraceptives are allowed without time limit. To ascertain the subject’s good health and to avoid interference with the purpose of the study
29 Any transient illness within 2 weeks before screening. To ensure the subject’s good health
30 Changes in physical exercise activities, e.g., starting workout/training within 1 week before screening. To avoid interference with the purpose of the study
31 Current or recent (during the preceding 2 weeks) acute pain lasting more than 4 h. To avoid interference with the purpose of the study
32 Jet lag / irregular working hours / sleep restriction in the last 3 days before the screening period. To avoid interference with the purpose of the study
  1. Reproduced from [2]