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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06071962
Other study ID # DISCOVER__(MBP)
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 2, 2023
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Apurano Pharmaceuticals GmbH
Contact Marko Blisse
Phone +49 8024 46869 28
Email marko.blisse@apurano.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the long term efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic back pain disorders. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic back pain.


Recruitment information / eligibility

Status Recruiting
Enrollment 558
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Adezunap (AP707)
Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.
Placebo
Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.

Locations

Country Name City State
Germany Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie) Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Apurano Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Number and severity of adverse events (AE) Week 1 to 52
Primary Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 14 (end of first treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo) Once daily in week 4 and 14
Secondary Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 26 (end of second treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo) Once daily in week 4 and 26
Secondary Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 52 (end of third treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo) Once daily in week 4 and 52
Secondary Change in the pain score of the Neuropathic Pain Symptom Inventory (NPSI) questionnaire between baseline and at treatment week 14, treatment week 26 and treatment week 52 in comparison of study arm 1 (verum) and study arm 2 (placebo) Once in week 1, 14, 26 and 52
Secondary Change in pain level on the Numeric Rating Scale (0-10) between baseline and in treatment week 5, 11, 18, 22, 30, 34, 43, 47 in comparison of study arm 1 (verum) and study arm 2 (placebo) Several times weekly in week 4, 5, 11, 18, 22, 30, 34, 43 and 47
Secondary Responder analysis for endpoints 1), 2), 3) and 4) for treatment week 14, 26 and 52 Proportion of patients who experienced > 30 % improvement in pain score (Numeric Rating Scale)
Proportion of patients who experienced > 40 % improvement in pain score (Numeric Rating Scale)
Proportion of patients who experienced > 50 % improvement in pain score (Numeric Rating Scale)
Week 14, 26 and 52
Secondary Change in sCPT (percentage of change in dosage and percentage of change in combination of analgesic measures) in both study arms from start to week 14 Week 14
Secondary Change in pain-related impairment according to von Korff et al. from start to week 14, 26, and 52 Week 1, 14, 26 and 52
Secondary Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14, 26, and 52 Week 1, 14, 26 and 52
Secondary Change of Patient Global Impression of Change (PGIC) from start to week 14, 26, and 52 Week 14, 26 and 52
Secondary Change in quality of life using the Veterans RAND (VR-12) questionnaire from start to week 14, 26, and 52 Week 1, 14, 26 and 52
Secondary Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14, 26, and 52 Week 1, 14, 26 and 52
Secondary Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from start to week 14, 26, and 52 Week 1, 14, 26 and 52
Secondary Area under NRS-curve until treatment week 5, 11, 14, 18, 22, 26, 30, 34, 39, 43, 47, 52 Week 5, 12, 18, 22, 26, 30, 34, 39, 43, 47 and 52
Secondary Change in VR-12 components (physical component summary PCS, mental component summary MCS) from start to week 14, 26, and 52 Week 1, 14, 26 and 52
Secondary Number of patients with rescue medication over the course of the clinical trial and within periods: until treatment week =5, =11, =14, =18, =22, =26, =30, =34, =43, =47, =52 Week 5, 11, 14, 18, 22, 26, 30, 34, 43, 47 and 52
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