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: LYRICA - 75 MG CAPSULA RIGIDA - USO ORALE 100 CAPSULE IN BLISTER IN UNITA' SEPARABILI PERFORATO (PVC/ALU)
Product Name: pregabalin
Product Code: [N03AX16]
Pharmaceutical Form: Capsule, ha
Sponsors
UMBERTO I - POLICLINICO DI ROMA
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 in good general health as evidenced by medical history - 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
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 and will not interfere with the results of the study - Known or suspected allergic reactions / hypersensitivity to components of lacosamide/Vimpat®, pregabalin/Lyrica®, tapentadol / Palexia®. . - Second- or third-degree atrioventricular (AV) block. - Known contraindication for drugs with µ-opioid agonist activity, i.e., significant respiratory depression, acute or severe bronchial asthma orhypercapnia. - 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 antiepileptic, 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, hypoor hyperthyroidism, hypertension etc.). - Diseases or conditions known to interfere with the distribution, metabolism, or excretion of drugs. - Clinically significant disease 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 trial conduct; any person under the direct supervision of the investigator or dependent on the investigator. - Blood loss of 500 mL or more (e.g., owing to blood donation) within 3 months before enrollment in this trial. - Pregnancy, planned pregnancy or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To test if the percentage reduction of RIII flexion reflex area 60 minutes post-drug administration differs in the tapentadol period as compared to the placebo period, at the sensitized limb 2. To test if the percentage reduction of N13 amplitude 60 minutes postdrugm administration differs in the tapentadol period as compared to the placebo period, at the sensitized limb;Secondary Objective: 1. To test if the percentage reduction of RIII flexion reflex area 60 minutes post-drug administration differs in the pregabalin and/or lacosamide sessions as compared to the placebo period, at the sensitized limb. 2. To test if the percentage reduction of N13 amplitude 60 minutes postdrug administration differs in the pregabalin and/or lacosamide period as compared to the placebo period, at the sensitized arm. 3. To test if the percentage reduction of R2 recovery cycle at 500 ms interstimulus time-intervals after supraorbital nerve stimulation of the non-sensitized side, 60 minutes post-drug administration differs in the tapentadol, pregabalin and/or lacosamide sessions as compared to the placebo period.;Primary end point(s): - the percentage of change of the RIII area of the flexion reflex at the time point t60 post-drug administration vs the pre-drug time point, at the sensitized lower limb. - is the percentage of amplitude changes of the N13-SEP at the time point t60 post-drug administration vs the pre-drug time point, at the sensitized upper arm;Timepoint(s) of evaluation of this end point: Endpoints are evaluated at t60 post-drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The percentage of change of the R2 recovery cycle at 500 ms interstimulus time interval at the time point T60 post-drug administration vs the pre-drug administration - Change in the RIII threshold across all post-drug time-points vs. the pre-drug baseline time point differs significantly in the four treatmentsessions, at the sensitized limb - The percentage of change in the intensity of the sensation elicited by the electrical stimulation for the RIII reflex recording, as assessed with the NRS 0-100 points, at time-point T+60 min post-drug administration vs. the pre-drug time-point, at the sensitized limb. - Change of the RIII area of the flexion reflex at the time point t60 postdrug administration vs the pre-drug time point, at the non-sensitized limb.;Timepoint(s) of evaluation of this end point: Endpoints are evaluated at t60 post-drug administration. | — |
Countries
Belgium, France, Germany, Italy
Contacts
Public ContactDipartimento di Neuroscienze Umane
Sapienza Università di Roma
Outcome results
None listed