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

Last updated: January 30, 2024
Sponsor: Apurano Pharmaceuticals GmbH
Overall Status: Active - Recruiting

Phase

3

Condition

Acute Pain

Reflex Sympathetic Dystrophy Syndrome (Rsds)

Chronic Pain

Treatment

Adezunap (AP707)

Placebo

Clinical Study ID

NCT06071936
DISCOVER_(PNP2)
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed and dated informed consent form
  2. Patients with chronic pain due to traumatic or post-operative peripheral neuropathysince 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 studyparticipation 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

Exclusion

Exclusion Criteria:

  1. Medical history of hypersensitivity or intolerance to the investigational product orits 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 thanthat 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, bipolardisorder, 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 ofNormal 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

Total Participants: 558
Treatment Group(s): 2
Primary Treatment: Adezunap (AP707)
Phase: 3
Study Start date:
November 02, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie)

    Munich, Bavaria 81675
    Germany

    Active - Recruiting

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