Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyne… (NCT06071975) | Clinical Trial Compass
UnknownPhase 3
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy
Germany558 participantsStarted 2023-11-02
Plain-language summary
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 long term efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with pain disorders due to diabetic polyneuropathy. 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 diabetic polyneuropathy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed and dated informed consent form
✓. Patients with chronic pain due to diabetic polyneuropathy 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
Exclusion criteria
✕. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
What they're measuring
1
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)