Status:
UNKNOWN
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
Lead Sponsor:
Apurano Pharmaceuticals GmbH
Conditions:
Pain
Pain Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, thi...
Eligibility Criteria
Inclusion
- Signed and dated informed consent form
- Patients with chronic pain due to central neuropathy of any genesis 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
Exclusion
- 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.
- 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 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
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT06071949
Start Date
November 2 2023
End Date
December 31 2024
Last Update
January 31 2024
Active Locations (1)
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1
Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie)
Munich, Bavaria, Germany, 81675