Evaluating the long-term effects of AP707 on chronic pain from nerve damage
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy
This study is testing if a new treatment called AP707 can help people with chronic pain from nerve damage feel better over 14 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 558 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Apurano Pharmaceuticals GmbH Industry-sponsored |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT06071988 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the long-term efficacy and tolerability of AP707, a THC-focused nano endocannabinoid system modulator, in patients suffering from chronic pain due to traumatic or post-operative peripheral neuropathy. Participants will receive either AP707 or a placebo for 14 weeks, alongside their standard pain management regimen. The study aims to assess changes in pain intensity, quality of life, and sleep through various measurement scales to determine the effectiveness of AP707 in alleviating chronic pain symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with chronic pain from traumatic or post-operative peripheral neuropathy lasting at least three months.
Not a fit: Patients with a history of hypersensitivity or intolerance to the investigational product will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for patients with chronic pain due to nerve damage.
How similar studies have performed: Previous studies have indicated the potential of cannabinoids in managing chronic pain, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Munich, Bavaria
- Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie) — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Marko Blisse
- Email: marko.blisse@apurano.de
- Phone: +49 8024 46869 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.