Post-surgical neuropathic pain (PSNP) MedDRA version: 21.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852
Conditions
Sponsors
Averitas Pharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General 1. The subject has given written informed consent to participate. 2. Female or male subjects aged 18 years or older. 3. For women of childbearing potential: negative pregnancy tests at Screening Visit (Visit 1), the Randomization Visit (Visit 2), and prior to each reapplication of the IMP, and must have agreed to practice medically acceptable methods of birth control. Confirmation of diagnosis of chronic moderate to severe PSNP (see also Protocol Table 1) 4. Documented diagnosis of PSNP by the following criteria: a. A history of post-surgical pain with a duration of at least 6 months to maximally 36 months that is plausibly related to the surgical intervention as documented on a body map. b. DN4i of at least 3 out of 7 points at Visit 1. c. The pain must extend beyond the scar area to neuroanatomically adjacent skin areas and be related to the site of the surgery. 5. Documented diagnosis of probable or definite PSNP according to the following criteria: a. The pain must be associated with sensory signs in the same neuroanatomically plausible distribution. The area of sensory changes may extend beyond, be within, or overlap with the area of pain (criterion for probable neuropathic pain), or b. In addition to 5a : Direct surgical evidence (e.g., surgeon´s clear verification of an intraoperative nerve lesion) (criterion for definite neuropathic pain). 6. The subject has moderate to severe pain with a baseline value for 24-hr average pain intensity of at least 4 points on the NPRS. The baseline value is calculated as the average of the 24-hr average pain intensity ratings of the Baseline Phase (Day -7 to Day -1). At least 5 (out of 7) pain ratings should be available during the Baseline Phase. If less than 5 pain ratings are available, the subject may be rescheduled for Visit 2 (1 time only) after having received appropriate re-training in the use of the e-diary to ensure compliance. Suitability for treatment with IMP 7. The size of the affected painful intact skin area is not larger than the size of 4 standard Qutenza topical systems (1120 cm2). 8. The skin in the area where the IMP will be applied, and that may also contain the scar tissue, is intact, dry, and non-irritated (i.e., there are no signs and symptoms of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, ulceration, wounds). Eligibility with regard to protocol adherence, to allowed pre-treatments and concomitant treatments 9. The subject is willing to adhere to the restricted use of concomitant treatments (see concomitant treatments in Section 1.4.2). 10. The subject experiencing pain is: a. currently not receiving treatment for PSNP or b. receives a stable systemic treatment for PSNP that started more than 30 days prior to the Randomization Visit (Visit 2). 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 340 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: General or previous treatments 1. The subject received Qutenza before the Randomization Visit (Visit 2) or received a medical device in another clinical trial within 7 days before the Randomization Visit (Visit 2), or a. Any former use of topical capsaicin in the area of the PSNP before Visit 2, except for the use of a low-dose (<1%) capsaicin product – but not within 7 days before Visit 2. b. The subject participated previously in this clinical trial or participated in another clinical trial for the treatment of PSNP completing less than 3 months ago. 2. A score of 0 out of 5 in all 3 categories of the neurological/sensory examinations, i.e., for warm sensation, pinprick and cold sensation at the Screening Visit (Visit 1). Confounding factors 3. The subject reported a 24-hr average pain intensity score of 10 on the NPRS for at least 4 days during the Baseline Phase. 4. Any painful procedure planned during the course of the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments. 5. Subjects with PSNP related to a surgery/condition with a high potential for confounding symptoms, e.g., the pain is at least partially due to pain in deeper structures such as muscles or bones (including referred pain from deeper structures) as listed in examples in Protocol Table 2. 6. Other painful conditions in the body area that is affected by PSNP and may affect efficacy or safety assessments including infectious, non-infectious, inflammatory or neuropathic conditions which could also be complications related to the previous surgical procedure. Contraindications to IMP 7. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. 8. Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), or to any excipients of the IMP or to excipients of the cleansing gel in use and their components, or to topical anesthetics in use and their components. Medical history/concurrent condition(s)/other factors 9. Pending litigation due to chronic pain or disability. 10. The subject has a history of alcohol or drug abuse or is actively abusing drugs (including alcohol, medication) during the 1 year prior to the Screening Visit (Visit 1) as judged by the investigator. 11. Evidence or history of severe psychiatric illness/disorder during the 3 years prior to the Screening Visit (Visit 1) that, in the investigator’s opinion, may affect efficacy or safety assessments or may compromise the subject’s safety during trial participation, e.g., major depression, major anxiety disorder, psychosis, severe personality disorders. 12. Evidence of cognitive impairment including dementia that may interfere with the subject’s ability to complete pain assessments requiring recall of the average pain level in the past 24 hrs. 13. Surgical intervention in the last 3 months preceding the Screening Visit (Visit 1) if it is affecting the efficacy or safety assessments, or any scheduled or planned surgery during the trial, with the exception of the Extension Phase if the planned surgery is not expected to affect the efficacy or safety assessments. 14. Patients with current clinically significant disease(s) or condition(s) (including clinically significant cardiovascular disease and/or significant pain in other areas) that may affect efficacy or safety assessments, or any other reason which, in the investigator’s opinion, may prec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of Qutenza over low-dose capsaicin control in change from baseline to Week 12 in the 24-hr average pain intensity in subjects with PSNP.;Secondary Objective: Core Phase: • To demonstrate superiority of Qutenza over low-dose capsaicin control in change from baseline to Week 12 in treatment area size in subjects with PSNP. • To assess the safety and tolerability of Qutenza in subjects with PSNP. Extension Phase: • To confirm the long-term efficacy of Qutenza in subjects with PSNP. • To assess the long-term safety and tolerability of Qutenza in subjects with PSNP.;Primary end point(s): Change from baseline to the average score of the entire period between Week 2 and Week 12 in the 24-hr average pain intensity.;Timepoint(s) of evaluation of this end point: from the Baseline Phase (Day -7 to Day -1) to Visit 6 (Week 12/Day 84). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Core Phase: 1. Change from baseline to Week 12 in the treatment area size. 2. Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to discontinuation in the Core Phase. Extension Phase: 1. Change from baseline to the weekly average score of Week 42 in the 24-hr average pain intensity. 2. Change from baseline to Week 42 in the treatment area size. 3. Change from baseline to the average score of the entire period between Week 2 and Week 42 in the 24-hr average pain intensity. 4. Incidence of TEAEs. Incidence of TEAEs leading to discontinuation in the Extension Phase.;Timepoint(s) of evaluation of this end point: Core Phase 1. At Visit 2 (Day 1) before IMP application and at Visit 6 before IMP application (Week 12/Day 84) 2. Documentation of TEAEs from the start of treatment at Visit 2(Day 1) up to the time of the last scheduled contact in the Core Phase of the Treatment Period Extension Phase 1.From the Baseline Phase(Day -7 to Day -1) to Final Visit(Week 42/Day 294) 2.At Visit 2 (Day 1) before IMP application and at Visit 6 before IMP application (Week 12/Day 84) 3.From the Baseline Phase (Day -7 to Day -1) to the Final Visit(Week 42/Day 294) 4.Documentation of TEAEs from start of treatment at Visit 2(Day 1) up to the time of the last scheduled contact in the Extension Phase of the Treatment Period | — |
Countries
France, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactHead of Medical Affairs
Averitas Pharma, Inc.
Outcome results
None listed