EUCTR2019-001204-37-IT进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by electroencephalography (EEG) - Gli effetti di lacosamide, pregabalin e tapentadolo sui biomarcatori del dolore
MBERTO I - POLICLINICO DI ROMA0 个研究点目标入组 56 人开始时间: 2021年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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 methodduring 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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-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 study results
- •-Known or suspected allergic reactions / hypersensitivity to components of lacosamide/Vimpat®- pregabalin/Lyrica® and tapentadol / Palexia®.
- •-II or III degree atrioventricular 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 ofabuse test).
- •-Consumption of more than 21 alcohol units per week for male subjects and more than 14 units per week for female subjects (1alcohol 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 lactation.
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