The effects of lacosamide, pregabalin and tapentadol on biomarkers of peripheral pain processing
- Conditions
- Healthy volunteers (intended indication: pain)MedDRA version: 20.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditionsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2019-000942-36-BE
- Lead Sponsor
- Aarhus University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and regimens and availability for the duration of the study
Caucasian male or female subjects, aged 18 years to 45 years
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)
Body mass index >18 kg/m2 and < 30 kg/m2 with a minimum body weight of 45.0 kg and a maximum of 100kg (for men and women)
Ability to take oral medication
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, -progestogen-only hormonal contraception associated with inhibition of ovulation, -an intra-uterine device (hormone-free), -an intra-uterine hormone releasing system (IUS). A woman of non-childbearing potential may be included if surgically sterile (i.e., after hysterectomy or bilateral oophorectomy) or post-menopausal for at least 2 years.
Right hand dominance (assessed using the Edinburgh Handedness Inventory, and defined as a score =60)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Presence of any medical devices (e.g., cardiac pacemaker), implants or protheses 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
Known or suspected allergic reactions / hypersensitivity to components of lacosamide/Vimpat®.
Second- or third-degree atrioventricular (AV) block.
Known or suspected allergic reactions / hypersensitivity to components of pregabalin/Lyrica®.
Known or suspected allergic reactions / 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.
Not willing or able to abstain from changes in physical exercise activities during the Study.
Any chronic pain condition or recent (i.e. within the preceding 2 years) history thereof.
Migraine (at least 1 attack in the last 24 months).
Recurrent headache or back pain on more than 5 days/month in the last 3 months.
Caffeine consumption of more than 8 servings of coffee, tea, or other caffeinated drinks per day. Each serving is approximately 120mg of caffeine.
Any relevant symptom of neurological dysfunction of the motor and sensory system that may interfere with the conduct of the study.
Clinically-evident psychiatric diseases (e.g. depression, anxiety).
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.
Focused neurological examination showing signs of abnormality.
Active internal disease or sequelae of internal disease (e.g. diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases, hypo- or hyperthyroidism, hypertension etc.).
Diseases or conditions known to interfere with the distribution, metabolism, or excretion of drugs.
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.
Not willing or able to abstain from alcohol from 48 hours prior to any study period and until the end of the study period.
Consumption of cannabis in the last 4 weeks prior to the study.
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).
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.
Known or suspected of not being willing or able to comply with the requirements of the trial protocol or the instructions.
Inability to communicate meaningfully with the trial site staff (e.g. insufficient language skills).
Any person with di
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method