NCT02301169已完成不适用
A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment
研究概览
简要总结
The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women of at least 18 years of age
- •Body weight of more than 40 kg and less than 120 kg with a BMI between 19-31 kg/m2 inclusive
- •Diagnosed with Peripheral Neuropathic Pain (PNP) since at least 6 months
- •Being affiliated with the national welfare system
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- •Have given written informed consent approved by the relevant Ethics Committee (EC) governing the study site
- •PNP disease diagnosis inclusion criteria:
- •Patient with chronic PNP supported by a distinct neuroanatomical plausible distribution with sensory signs and symptoms, and consecutive to one of the following causes: a traumatic event, a surgical procedure (excluding limb amputation), radiculopathy, post-herpetic or post-zooster neuralgia, diabetic polyneuropathy or post-anticancer chemotherapy. Diagnosis will have to be confirmed by the DN4 questionnaire at the screening visit (pain is considered as neuropathic if DN4 score ≥ 4)
- •Pain present since at least 6 months
- •Patients will be required to have a score between 4 and 8 inclusive on the mean Average Pain Score (APS) Numeric Rating Scale (NRS) during the baseline period preceding randomization (data collected in patient diary) and to have completed at least 4 days of pain assessment
排除标准
- •Pregnant, breastfeeding, or willing to be pregnant within 2 months
- •With a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study
- •Uncontrolled epilepsy
- •Any current primary psychiatric condition, including major depression or major personality disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV); personality disorders and mental retardation)
- •Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine)
- •Acute disease state within 7 days before Visit 2
- •Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient
- •Any close relationship with the Investigators or the Sponsor (i.e. belonging to immediate family or subordination link)
- •Patient under legal protection, according to the national law
- •Patient currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to national law
- •Exclusion criteria related to PNP:
- •Neuropathic pain due to trigeminal neuralgia, central pain, complex regional pain syndrome and phantom limb pain
- •Plan to have a session of physiotherapy or comportemental therapy such as gestion of pain, hypnosis, sophrology, meditation program during the study
- •Have initiated or have planned an electrical stimulation (or neurostimulation) therapy within 2 weeks prior to Visit 1 or during the study period up to Visit 5
- •Patient changed his/her " regular therapy " in the last 4 months
研究组 & 干预措施
Placebo
Sham Comparator
干预措施: Heat pain stimuli B (Behavioral)
T4P1001
Active Comparator
干预措施: Heat pain stimuli A (Behavioral)
T4P1001
Active Comparator
干预措施: Video A (Behavioral)
T4P1001
Active Comparator
干预措施: Administration of T4P1001 capsules (Drug)
Placebo
Sham Comparator
干预措施: Video B (Behavioral)
Placebo
Sham Comparator
干预措施: Administration of placebo capsules (Drug)
结局指标
主要结局
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment
时间窗: Time zero equals baseline (Day 1) up to Day 42
11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS
次要结局
- Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)(Time zero equals baseline (Day 1) up to Day 42)
- Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)(Time zero equals baseline (Day 1) up to Day 28)
- Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period(Time zero equals baseline (Day 1) up to Day 28)
- Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).(Time zero equals baseline (Day 1) up to Day 28)
研究者
研究点 (1)
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