Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain

NCT ID: NCT06072560

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2024-12-31

Brief 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 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.

Conditions

Pain; Pain Syndrome; Pain, Chronic; Chronic Pain; Chronic Pain Syndrome; Back Pain; Lower Back Pain; Lower Back Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group

Group Type: EXPERIMENTAL

Adezunap (AP707)

Intervention Type: DRUG

Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.

Control group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.

Interventions

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.

Intervention Type: DRUG

Placebo

Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apurano Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie)

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Marko Blisse

Role: CONTACT

marko.blisse@apurano.de

+49 8024 46869 28

Facility Contacts

Katharina Haas

Role: primary

Other Identifiers

DISCOVER_(MBP)

Identifier Type: -

Identifier Source: org_study_id