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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed and dated informed consent form
- Patients with chronic pain due to traumatic or post-operative peripheral neuropathysince 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 studyparticipation 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
Exclusion
Exclusion Criteria:
- Medical history of hypersensitivity or intolerance to the investigational product orits ingredients or to ingredients of similar chemical structure
- Known intolerance to cannabinoids or cannabis products.
- Participation in another clinical trial within the last four weeks prior to inclusion.
- 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 thanthat 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, bipolardisorder, 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 ofNormal 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
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
GermanyActive - Recruiting
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