Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy

NCT06071936 | Unknown Phase 3

• 1 other identifier: DISCOVER_(PNP2)
• 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 efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to traumatic or post-operative peripheral neuropathy. 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 pain due to traumatic or post-operative peripheral neuropathy.

Conditions

Pain; Pain Syndrome; Pain, Chronic; Chronic Pain; Chronic Pain Syndrome; Neuropathic Pain; Peripheral Neuropathy; Peripheral Neuralgia; Peripheral Nerve Injury; Post Operative Pain; Post-Traumatic Neuralgia; Plexopathy

Keywords

Adezunap; Pain Therapy; Pain; Pain Syndrome; Chronic Pain; Chronic Pain Syndrome; Peripheral Nervous System; PNS; Neuropathic Pain; Peripheral Neuropathy; Peripheral Neuralgia; Peripheral Nerve Injury; Post Operative Pain; Post-Traumatic Neuralgia; Plexopathy; THC; Tetrahydrocannabinol; Delta-9-Tetrahydrocannabinol; Cannabis; Cannabinoids

Outcome Measures

Primary Outcomes (13)

• 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

• Change in the pain score of the Neuropathic Pain Symptom Inventory (NPSI) questionnaire between baseline and at treatment week 14 in comparison of study arm 1 (verum) and study arm 2 (placebo)

  Week 1 and 14

• Change in pain level on the Numeric Rating Scale (0-10) between baseline and in treatment week 5 and 11 in comparison of study arm 1 (verum) and study arm 2 (placebo)

  Several times weekly in week 4, 5 and 11

• Responder analysis for endpoints 1) for treatment week 14

  1. Proportion of patients who experienced \> 30 % improvement in pain score (Numeric Rating Scale) 2. Proportion of patients who experienced \> 40 % improvement in pain score (Numeric Rating Scale) 3. Proportion of patients who experienced \> 50 % improvement in pain score (Numeric Rating Scale)

  Week 14

• 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

• Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14

  Week 1 and 14

• Change of Patient Global Impression of Change (PGIC) from start to week 14

  Week 14

• Change in quality of life using the Veterans RAND (VR-12) questionnaire from start to week 14

  Week 1 and 14

• Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14

  Week 1 and 14

• Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from start to week 14

  Week 1 and 14

• Area under NRS-curve until treatment week 5, 11 and 14

  Week 5, 11 and 14

• Change in VR-12 components (physical component summary PCS, mental component summary MCS) from start to week 14

  Week 1 and 14

• Number of patients with rescue medication over the course of the clinical trial and within periods: until treatment week ≤5, ≤11 and ≤14

  Week 5, 11 and 14

Secondary Outcomes (1)

• Number and severity of adverse events (AE)

  Week 1 to 14

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

PLACEBO COMPARATOR

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 pain due to traumatic or post-operative peripheral neuropathy 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

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; Neuralgia; Peripheral Nervous System Diseases; Peripheral Nerve Injuries; Pain, Postoperative; Agnosia; Marijuana Abuse

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; 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)