Overview
Sponsor-declared trial summary
Chronic postchirurgical or post-traumatic neuropathic pain
To prove analgesic effectiveness of capsaicin 8% cutaneous patch in chronic postsurgical or post-traumatic neuropathic pain in children aged 12 to 17-y. Improvement of Neuropathic Pain Symptom Inventory (NPSI) score will be evaluated before the first application of capsaicin or placebo and 4 months later, after one or …
Key facts
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Mar 2024 → ongoing
- Decision date (initial)
- 2023-07-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-500265-27-00
- ClinicalTrials.gov
- NCT05997979
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To prove analgesic effectiveness of capsaicin 8% cutaneous patch in chronic postsurgical or post-traumatic neuropathic pain in children aged 12 to 17-y. Improvement of Neuropathic Pain Symptom Inventory (NPSI) score will be evaluated before the first application of capsaicin or placebo and 4 months later, after one or two applications.
Secondary objectives 5
- Evaluation of tolerance and safety, during application and in the following days.
- Evaluation of analgesic effectiveness with NPSI
- Evaluation of subscores of NPSI.
- Evaluation of improvement in function with Functional Disability Inventory (FDI).
- Impact of topical capsaicin treatment on concomitant pain medication and non pharmacologic pain therapies.
Conditions and MedDRA coding
Chronic postchirurgical or post-traumatic neuropathic pain
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10054095 | Neuropathic pain | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling)
- Male or female.
- Persistent neuropathic pain more than 32 months after surgery or trauma despite treatment following recommendations
- Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, and localized in a nerve territory explained by the surgery or the trauma
- Treatment, survey and follow up must be realized in an identified investigating center of the study.
Exclusion criteria 7
- Intellectual deficiency not allowing full filling of NPSI.
- Insuffisant command of the French language to full fill NPSI and other evaluation tools.
- Parents’ refusal of consent.
- Underlying neurological disease.
- Ongoing neurotoxic treatment.
- Already treated by capsaicin.
- Cutaneous lesion on pain area.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference in Neuropathic Pain Symptom Inventory score evaluated between the first application (M0) of capsaicin or placebo and 4 months later (M4).
Secondary endpoints 7
- Adverse event monitoring are collected during patch application and by phone calls in the following days.
- Vital signs including cardiac frequency and arteriel pressure.
- Physical examination including dermal assessment
- Intake of rescue medication against pain (YES/NO)
- Duration of patch application
- Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome
- Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Qutenza 179 mg cutaneous patch
PRD4980581 · Product
- Active substance
- Capsaicin
- Pharmaceutical form
- CUTANEOUS PATCH
- Route of administration
- CUTANEOUS USE
- Authorisation status
- Authorised
- ATC code
- N01BX04 — CAPSAICIN
- Marketing authorisation
- EU/1/09/524/002
- MA holder
- GRÜNENTHAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- For this study, the QUTENZA will be use for children
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- CUTANEOUS USE
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Tramadol 100 mg/ml oral drops, solution
PRD1171767 · Product
- Active substance
- Tramadol
- Pharmaceutical form
- ORAL DROPS, SOLUTION
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- N02AX02 — TRAMADOL
- Marketing authorisation
- PL 12762/0453
- MA holder
- MERCURY PHARMACEUTICALS LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Et Universitaire De Brest
- Sponsor organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Address
- 2 Avenue Marechal Foch
- City
- Brest
- Postcode
- 29200
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Dr Philippe LE MOINE
Public contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Dr Philippe LE MOINE
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 46 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-03-05 | 2024-03-05 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-21 | France | Acceptable 2023-07-10
|
2023-07-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-25 | France | Acceptable 2023-10-10
|
2023-11-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-24 | France | Acceptable 2024-03-11
|
2024-03-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-12 | France | Acceptable | 2025-02-04 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-24 | France | Acceptable | 2025-02-24 |