Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy

Launched by APURANO PHARMACEUTICALS GMBH · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AP707 for patients suffering from chronic pain caused by diabetic polyneuropathy, a common condition in people with diabetes that affects the nerves and can lead to pain. The trial aims to determine how effective and tolerable AP707 is over a 14-week period when used alongside standard pain management. Participants will either receive AP707 or a placebo (a non-active substance) and will be asked about their pain levels, quality of life, and sleep to see if the treatment helps relieve their symptoms.

To participate in the trial, individuals must be over 18 years old and have experienced chronic pain from diabetic polyneuropathy for at least three months. They should also be able to communicate in German and have moderate to severe pain levels. Those interested will need to sign a consent form and meet other health-related criteria. Throughout the study, participants can expect regular check-ins to monitor their progress and any side effects. This trial is currently recruiting, and it's a great opportunity for those looking for new ways to manage their chronic pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent form
• • 2. Patients with chronic pain due to diabetic polyneuropathy 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