Healthy volunteers (intended indication: pain) MedDRA version: 20.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Trade Name: Vimpat 100 mg film coated tablets
Product Name: lacosamide
Pharmaceutical Form: Tablet
INN or Proposed INN: LACOSAMIDE
CAS Number: 175481-36-4
Other descriptive name: Lacosamide
Concentra
Sponsors
Aarhus University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 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 direct involvement in the tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To test if the punctate evoked BOLD response in the posterior insula at 3 hours post-drug administration differs in pregabalin period as compared to the placebo period, at the sensitized leg. 2. To test if the resting state connectivity between SII and thalamus at 3 hours post-drug administration in the presence of sensitization differs in the pregabalin period as compared to the placebo period. ;Secondary Objective: 1. To test if the punctate evoked BOLD response in the posterior insula at 1 hour post-drug administration differs in at least one analgesic treatment period as compared to the placebo period, at the sensitized leg. 2. To test if the resting state connectivity between SII and thalamus at 1 hour post-drug administration in the presence of sensitization differs in at least one analgesic treatment session as compared to the placebo session.;Primary end point(s): The primary endpoints are the evoked neural activity response in the posterior insula (first primary endpoint), and the functional connectivity between the thalamus and the secondary somato-sensory cortex (SII, second primary endpoint) in a centrally sensitized state, as measured by using BOLD signal at the second imaging time point (approx. 3h post dose). Here we use 2 functional neuroimaging signals using the BOLD signal. First one is the BOLD signal evoked by the pin-prick stimulus applied to the sensitized skin. The second is the BOLD signal obtained when the subjects are awake but resting. This resting BOLD signal will be used for assessing the functional connectivity between brain regions. The main outcome of interest is the comparison between pregabalin and placebo.;Timepoint(s) of evaluation of this end point: 3 hour post-drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints are defined like the two primary endpoints. However, here the defined time point is at the first imaging session, approx. 1h post dose. Other secondary endpoints are the changes from baseline (within period) in pin-prick ratings reported by the subjects when stimulating the hyperalgesic area of skin and the primary endpoints (i.e. evoked neural activity response in the posterior insula, and the functional connectivity between the thalamus and the secondary somato-sensory cortex in a centrally sensitized state, as measured by using pin-prick stimulus-evoked and resting BOLD signal) but for the comparison between tapentadol and placebo and between lacosamide and placebo.;Timepoint(s) of evaluation of this end point: -1 hour post-drug administration -changes from baseline within period | — |
Countries
Denmark, France, United Kingdom
Contacts
Public ContactDanish Pain Research Center
Aarhus University
Outcome results
None listed