Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis

Launched by APURANO PHARMACEUTICALS GMBH · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called AP707 for people suffering from chronic pain caused by conditions like multiple sclerosis, strokes, or traumatic brain injuries. Researchers want to see if AP707, which is based on compounds found in cannabis, can help reduce pain and improve the overall quality of life for patients. The study lasts for 14 weeks, during which participants will either receive AP707 or a placebo (a non-active treatment) while continuing their regular pain management therapies. Throughout the trial, their pain levels, sleep quality, and general well-being will be monitored.

To join this study, participants must be adults over 18 years old with chronic pain from central neuropathy for at least three months. They should have a significant level of pain, as indicated by a score of over 5 on a pain scale from 0 to 10. Eligible participants also need to be able to understand German, provide informed consent, and use reliable contraception during the study. It's important to note that individuals with certain health issues or who have recently participated in other clinical trials will not be eligible. If you meet the criteria and are interested, this study could offer a potential new option for managing chronic pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent form
• • 2. Patients with chronic pain due to central neuropathy of any genesis since at least 3 months
• • 3. Female and male patients (\> 18 years)
• • 4. Patients with more than 1 year life expectancy
• • 5. Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
• • 6. Willingness of study patients of both sexes to use reliable contraception during study participation and for three months after taking the last study medication
• • 7. Good command of German language, in order to understand questionnaires in German
• • 8. 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
• • 9. Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with 45 or less score points
• Exclusion Criteria:
• • 1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
• • 2. Known intolerance to cannabinoids or cannabis products.
• • 3. Participation in another clinical trial within the last four weeks prior to inclusion.
• • 4. Pregnant or nursing women (as excluded by pregnancy testing at visit 1).
• • 5. Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
• • 6. Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
• • 7. Known use of medicinal cannabis products within the last 8 weeks
• • 8. Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
• • 9. Known history of severe liver or kidney diseases
• • 10. Known history of severe cardiovascular disease
• • 11. Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder
• • 12. Known history of addictive disease (e.g., alcohol, medication, drug addiction)
• • 13. Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
• • 14. 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
• • 15. Laboratory renal value: Serum creatinine \> 1.5 ULN