Testing a new treatment for chronic back pain

Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain

This study is testing a new treatment called AP707 to see if it can help people with chronic back pain feel better and improve their quality of life.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 558 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Apurano Pharmaceuticals GmbH (industry)
• Locations: 1 site (Munich, Bavaria)
• Trial ID: NCT06072560 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and tolerability of AP707, a THC-focused nano endocannabinoid system modulator, in patients suffering from chronic back pain. 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 the treatment. The trial is designed to address the growing medical need for effective chronic pain therapies.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with chronic back pain lasting at least three months and a pain intensity greater than 5 on a numeric scale.

Not a fit: Patients with a history of hypersensitivity or intolerance to the investigational drug 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 back pain.

How similar studies have performed: Previous studies have indicated the potential of cannabinoids in managing chronic pain, suggesting a promising avenue for this approach.

Eligibility criteria

Inclusion Criteria:

1. Signed and dated informed consent form
2. Patients with chronic back pain 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
10. Completed painDETECT questionnaire with 20 or more 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

Conditions: Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Back Pain, Lower Back Pain, Lower Back Pain Chronic