| Exclusion criteria at screening visit | Justification / rationale |
---|---|---|
01 | Presence of any medical devices (e.g., cardiac pacemaker), implants, or prosthesis 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 anti-epileptic, 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. | The investigator will specifically investigate the presence of any uncertainties of the subject and whether he/she correctly understood the study requirements, to ascertain the suitability for the study. |
22 | Inability to communicate meaningfully with the trial site staff (e.g., insufficient language skills), highlighted during the interview with the investigator. | 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, given the potential teratogenicity of the drugs used. |
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, the investigator is free to rely on his/her clinical experience to assess the suitability of the subject. |
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 |