A Phase 3 interventional study of Adezunap (AP707) and Placebo in Pain, Pain Syndrome and Pain, Chronic, sponsored by Apurano Pharmaceuticals GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Apurano Pharmaceuticals GmbH · Phase 3, Interventional, and Treatment
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 chronic pain disorders due to central neuropathy of any genesis. 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 central neuropathy of any genesis.
Exclusion Criteria:
Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.
Drug: Adezunap (AP707)
Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.
Drug: Placebo
Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.
Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.
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)
Time frame: Once daily in week 4 and 14
Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 26 (end of second treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
Time frame: Once daily in week 4 and 26
Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 52 (end of third treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
Time frame: Once daily in week 4 and 52
Change in the pain score of the Neuropathic Pain Symptom Inventory (NPSI) questionnaire between baseline and at treatment week 14, treatment week 26 and treatment week 52 in comparison of study arm 1 (verum) and study arm 2 (placebo)
Time frame: Once in week 1, 14, 26 and 52
Change in pain level on the Numeric Rating Scale (0-10) between baseline and in treatment week 5, 11, 18, 22, 30, 34, 43, 47 in comparison of study arm 1 (verum) and study arm 2 (placebo)
Time frame: Several times weekly in week 4, 5, 11, 18, 22, 30, 34, 43 and 47
Responder analysis for endpoints 1), 2), 3) and 4) for treatment week 14, 26 and 52
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)
Time frame: Week 14, 26 and 52
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
Time frame: Week 14
Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Change of Patient Global Impression of Change (PGIC) from start to week 14, 26, and 52
Time frame: Week 14, 26 and 52
Change in quality of life using the Veterans RAND (VR-12) questionnaire from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Area under NRS-curve until treatment week 5, 11, 14, 18, 22, 26, 30, 34, 39, 43, 47, 52
Time frame: Week 5, 12, 18, 22, 26, 30, 34, 39, 43, 47 and 52
Change in VR-12 components (physical component summary PCS, mental component summary MCS) from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Number of patients with rescue medication over the course of the clinical trial and within periods: until treatment week ≤5, ≤11, ≤14, ≤18, ≤22, ≤26, ≤30, ≤34, ≤43, ≤47, ≤52
Time frame: Week 5, 11, 14, 18, 22, 26, 30, 34, 43, 47 and 52
Number and severity of adverse events (AE)
Time frame: Week 1 to 52
Plan to share: No
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Apurano Pharmaceuticals GmbH