Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 14 (end of first treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
研究概览
简要总结
Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to traumatic or post-operative peripheral neuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to traumatic or post-operative peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed and dated informed consent form
- •Patients with chronic pain due to traumatic or post-operative peripheral neuropathy since at least 3 months
- •Female and male patients (> 18 years)
- •Patients with more than 1 year life expectancy
- •Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
- •Willingness of study patients of both sexes to use reliable contraception during study participation and for three months after taking the last study medication
- •Good command of German language, in order to understand questionnaires in German
- •Current moderate to severe pain with pain intensity > 5 on Numeric Rating Scale (NRS, 0 - 10) and thus an existing need for further pain therapy
- •Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with 45 or less score points
排除标准
- •Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- •Known intolerance to cannabinoids or cannabis products.
- •Participation in another clinical trial within the last four weeks prior to inclusion.
- •Pregnant or nursing women (as excluded by pregnancy testing at visit 1).
- •Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
- •Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
- •Known use of medicinal cannabis products within the last 8 weeks
- •Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
- •Known history of severe liver or kidney diseases
- •Known history of severe cardiovascular disease
- •Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder
- •Known history of addictive disease (e.g., alcohol, medication, drug addiction)
- •Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
- •Laboratory liver values: Alanine aminotransferase (ALT, GPT) > 3 x ULN (Upper Limit of Normal range), Aspartate aminotransferase (AST, GOT) > 3 x ULN, Alkaline phosphatase (AP) > 2.5 x ULN, and for bilirubin > 1.5 x ULN
- •Laboratory renal value: Serum creatinine > 1.5 ULN
研究组 & 干预措施
Treatment group
Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.
干预措施: Adezunap (AP707) (Drug)
Control group
Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 14 (end of first treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
时间窗: Once daily in Week 4 and 14
Change in the pain score of the Neuropathic Pain Symptom Inventory (NPSI) questionnaire between baseline and at treatment week 14 in comparison of study arm 1 (verum) and study arm 2 (placebo)
时间窗: Week 1 and 14
Change in pain level on the Numeric Rating Scale (0-10) between baseline and in treatment week 5 and 11 in comparison of study arm 1 (verum) and study arm 2 (placebo)
时间窗: Several times weekly in week 4, 5 and 11
Responder analysis for endpoints 1) for treatment week 14
时间窗: Week 14
1. Proportion of patients who experienced \> 30 % improvement in pain score (Numeric Rating Scale) 2. Proportion of patients who experienced \> 40 % improvement in pain score (Numeric Rating Scale) 3. Proportion of patients who experienced \> 50 % improvement in pain score (Numeric Rating Scale)
Change in sCPT (percentage of change in dosage and percentage of change in combination of analgesic measures) in both study arms from start to week 14
时间窗: Week 14
Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14
时间窗: Week 1 and 14
Change of Patient Global Impression of Change (PGIC) from start to week 14
时间窗: Week 14
Change in quality of life using the Veterans RAND (VR-12) questionnaire from start to week 14
时间窗: Week 1 and 14
Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14
时间窗: Week 1 and 14
Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from start to week 14
时间窗: Week 1 and 14
Area under NRS-curve until treatment week 5, 11 and 14
时间窗: Week 5, 11 and 14
Change in VR-12 components (physical component summary PCS, mental component summary MCS) from start to week 14
时间窗: Week 1 and 14
Number of patients with rescue medication over the course of the clinical trial and within periods: until treatment week ≤5, ≤11 and ≤14
时间窗: Week 5, 11 and 14
次要结局
- Number and severity of adverse events (AE)(Week 1 to 14)