Phase 2 study to evaluate the efficacy and safety of a ten-days treament of subjects with peripheral post-surgical neuropathic pain with drug AP-325 or placebo
- Conditions
- Peripheral post-surgical neuropathic painMedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-003502-28-ES
- Lead Sponsor
- Algiax Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 94
1. Subjects must be at least 18 years and not older than 80 years
2. Subjects with a diagnosis of chronic post-surgical neuropathic pain after breast surgery (breast cancer interventions), chest surgery (i.e. thoracotomy, video assisted thoracoscopy and sternotomy) or groin hernia repair (i.e. femoral hernia repairs and inguinal hernia repairs)
3. The chronic post-surgical pain developed or increased in intensity after the surgical procedure and persisted beyond the healing process, i.e. at least 3 months after the initiating event, as defined according to the international association for the study of pain (IASP) classification of chronic pain for ICD-11 (Schug et al., 2019)
4. Subjects must have ‘probable’ or ‘definite’ neuropathic pain as assessed by the revised IASP special interest group on neuropathic pain (NeuPSIG) grading system (Finnerup et al., 2016)
5. Subjects must be willing to discontinue and washout prohibited substances including
• pain medications (e.g. antidepressants, anticonvulsants/antiepileptics, selective serotonin and dual reuptake inhibitors, long-acting benzodiazepines, muscle relaxants, and topical analgesics), except the rescue medication, and
• substances known to be inhibitors or inducers of CYP2C9 and inhibitors of CYP3A4
for specific washout periods of at least 5 times the drug half-life
6. Permitted concomitant medications must have been stable for at least 4 weeks prior to Day -14 and any non-pharmacological therapies (e.g. physiotherapy, acupuncture and transcutaneous electrical neural stimulation) must have been initiated at least 3 weeks prior to Screening
7. Female subjects must not be pregnant or breastfeeding and be
• of non-childbearing potential or
• if of childbearing potential, use a highly effective contraceptive method from start of the IMP intake until 30 days after the last IMP intake and have a negative pregnancy test at Screening (blood test)
8. Male subjects must agree, from start of the IMP intake until 3 months after the last IMP intake, to refrain from donating sperm and use a male condom when having sexual intercourse with a woman of childbearing potential at any time and advise her to use a highly effective contraceptive method
9. Subjects must understand the nature of the study procedures and provide written informed consent prior to any study-related procedures
10. Body weight =55 kg for men and =50 kg for women
11. Body mass index (BMI) <35 kg/m²
Randomization criteria
1. At least 5 daily pain assessments in the baseline week prior to randomization, with a mean score on the PI-NRS =4 and =9. Differences between the baseline daily pain scores on the PI-NRS must be =50%.
2. For female subjects of childbearing potential: negative pregnancy test in urine on Day 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Subjects with neuropathic pain not a result of a surgical procedure as defined in inclusion criterion 2
2. Subjects with any other coexisting pain that cannot be discriminated from post-surgical neuropathic pain, in the opinion of the subject or clinician
3. Subjects diagnosed with chronic post-surgical neuropathic pain with a disease duration exceeding 3 years
4. Inability to participate in the study, in the opinion of the investigator, because of, for example, severe brain damage, language barrier, dementia, or other clinically significant or unstable conditions
5. Subjects using adjuvant chemotherapy
6. Creatinine clearance <60 mL/min using the Cockcroft-Gault formula
7. White blood cell count <2500/mm³; neutrophil count <1500/mm³; platelet count <100 x 10³/mm³
8. A history of multiple drug allergies
9. History or presence of alcohol or drug abuse
10. Subjects using strong opioids (e.g. a Morphine Equivalent Dose [MED] >80 mg/day)
11. Positive test for drugs of abuse at Screening
12. Evidence of depression and/or a score of =11 on the HADS subscale
13. Psychiatric disease in the past 5 years
14. History of any liver disease within the last 6 months, or migraine, or kidney dysfunction or disease (e.g. estimated glomerular filtration rate [eGFR] =30 mL/min per 1.73 m²)
15. Clinically significant gastrointestinal conditions, likely interfering with the study medication, study procedures or the outcome of the study
16. Positive test for human immunodeficiency virus (HIV)
17. Positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody and/or HIV1/HIV2 antibody at Screening
18. Participation of subject in an interventional clinical study within 1 month or, if applicable, 5 half-lives of the IMP, whatever is longer, before Screening or during participation in this study
19. Previous enrolment in this clinical study
20. Known hypersensitivity to the active substance or any of the excipients of the IMP or the rescue medication
21. Subjects dependent (as an employee or relative) on the sponsor or investigator
22. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
23. Legal incapacity or limited legal capacity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method