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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes. |
|
| Control group | Experimental | Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adezunap (AP707) | Drug | Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Once daily in week 4 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse events (AE) | Week 1 to 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marko Blisse | Contact | +49 8024 46869 28 | marko.blisse@apurano.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie) | Recruiting | Munich | Bavaria | 81675 | Germany |
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| Placebo | Drug | Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes. |
|
| 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) | 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) | 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 |
| 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 | Week 14 |
| Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14, 26, and 52 | Week 1, 14, 26 and 52 |
| Change of Patient Global Impression of Change (PGIC) from start to week 14, 26, and 52 | 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 | Week 1, 14, 26 and 52 |
| Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14, 26, and 52 | 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 | 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 | 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 | 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 | Week 5, 11, 14, 18, 22, 26, 30, 34, 43, 47 and 52 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D013001 | Somatoform Disorders |
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| D010264 | Paraplegia |
| D009103 | Multiple Sclerosis |
| D020521 | Stroke |
| D010591 | Phantom Limb |
| D000070642 | Brain Injuries, Traumatic |
| D000377 | Agnosia |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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