Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy

Launched by APURANO PHARMACEUTICALS GMBH · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AP707, which is being tested for its effectiveness in reducing chronic pain caused by nerve injuries from trauma or surgery. The aim is to see how well AP707 works over a period of 14 weeks when given alongside standard pain management treatments. Researchers will monitor changes in pain levels, quality of life, and sleep to understand how the treatment helps patients.

To participate, individuals need to be adults over 18 who have been experiencing chronic pain for at least three months and have a significant level of pain (rated above 5 on a scale from 0 to 10). Participants should also be in good health overall and able to understand questionnaires in German. Those who are pregnant, have certain medical conditions, or have used cannabis products recently may not be eligible. If you join the study, you'll receive either AP707 or a placebo (a treatment with no active ingredients), and you’ll be carefully monitored throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent form
• • 2. Patients with chronic pain due to traumatic or post-operative peripheral neuropathy 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