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 condition that affects the nerves due to diabetes. The trial aims to see how effective and well-tolerated AP707 is compared to a placebo (a non-active treatment) over a 14-week period. Participants will be monitored for changes in pain levels, quality of life, and sleep, among other factors, while continuing their standard pain management care.

To be eligible for this trial, participants should be adults aged 18 and older who have been experiencing chronic pain related to diabetic polyneuropathy for at least three months. They should also have moderate to severe pain that scores higher than 5 on a scale of 0 to 10. It’s important that they are able to understand German, as some questionnaires will be in that language. Participants can expect to take either AP707 or a placebo, and they will be closely monitored throughout the study to gather important information about the treatment's effects. If you or someone you know fits these criteria and is interested in exploring this potential new treatment option, this trial might be a good opportunity.

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