Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain

NCT06071962 | Unknown Phase 3

• 1 other identifier: DISCOVER__(MBP)
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

Adezunap; Pain Therapy; Pain; Pain Syndrome; Chronic Pain; Chronic Pain Syndrome; Back Pain; Chronic Back Pain; Lower Back Pain; Lower Back Pain Chronic; THC; Tetrahydrocannabinol; Delta-9-Tetrahydrocannabinol; Cannabis; Cannabinoids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

• 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

• 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

• 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

• Responder analysis for endpoints 1), 2), 3) and 4) for treatment week 14, 26 and 52

  Week 14, 26 and 52

Other Outcomes (1)

• Number and severity of adverse events (AE)

  Week 1 to 52

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Drug: Adezunap (AP707)

Control group

EXPERIMENTAL

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

Drug: Placebo

Interventions

Adezunap (AP707) 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.

Treatment group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form
• Patients with chronic back pain since at least 3 months
• Female and male patients (\> 18 years)
• Patients with more than 1 year life expectancy
• Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
• Willingness of study patients of both sexes to use reliable contraception during study participation and for three months after taking the last study medication
• Good command of German language, in order to understand questionnaires in German
• 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
• Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with 45 or less score points
• Completed painDETECT questionnaire with 20 or more score points

You may not qualify if:

• Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
• Known intolerance to cannabinoids or cannabis products.
• Pregnant or nursing women (as excluded by pregnancy testing at visit 1).
• Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
• Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
• Known use of medicinal cannabis products within the last 8 weeks
• Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
• Known history of severe liver or kidney diseases
• Known history of severe cardiovascular disease
• Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder
• Known history of addictive disease (e.g., alcohol, medication, drug addiction)
• Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
• 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
• Laboratory renal value: Serum creatinine \> 1.5 ULN

Sponsors & Collaborators

• Apurano Pharmaceuticals GmbH: lead

Study Sites (1)

Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie)

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Pain; Somatoform Disorders; Chronic Pain; Back Pain; Low Back Pain; Agnosia; Marijuana Abuse

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Marko Blisse

CONTACT

+49 8024 46869 28; marko.blisse@apurano.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: November 2, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)