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.
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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)
Timeframe: 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)
Timeframe: 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)
Timeframe: Several times weekly in week 4, 5 and 11
Responder analysis for endpoints 1) for treatment week 14
Timeframe: Week 14
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
Timeframe: Week 14
Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14
Timeframe: Week 1 and 14
Change of Patient Global Impression of Change (PGIC) from start to week 14
Timeframe: Week 14
Change in quality of life using the Veterans RAND (VR-12) questionnaire from start to week 14
Timeframe: Week 1 and 14
Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14
Timeframe: Week 1 and 14
Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from start to week 14
Timeframe: Week 1 and 14
Area under NRS-curve until treatment week 5, 11 and 14
Timeframe: Week 5, 11 and 14
Change in VR-12 components (physical component summary PCS, mental component summary MCS) from start to week 14
Timeframe: 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
Timeframe: Week 5, 11 and 14