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Tests treatment safety and results for Neuropathic Pain
Official title Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
ClinicalTrials.gov ID: NCT05997979
What this study is testing
What is Capsaicin 8% patch?
Capsaicin 8% patch is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for neuropathic pain.
Also referred to as QUTENZA®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery. It is a multicentric randomized controlled superiority trial in parallel arms : experimental arm: Capsaicin 8% cutaneous patch controlled arm : Hydrocolloid dressing Treatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch application if needed.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- 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 3 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...
- Treatment, survey and follow up must be realized in an identified investigating center of the study
You likely can't join if
- Intellectual deficiency not allowing full filling of NPSI.
- Insufficient command of the French language to full fill NPSI and other evaluation tools.
- Parents' refusal of consent.
- Minor patients' opposition.
- Underlying neurological disease.
- Ongoing neurotoxic treatment.
See the full eligibility criteria
- 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 3 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
- For patients of childbearing potential: use of an adequate method of contraception\ during the course of the study through 48 hours after the last patch application (girls of childbearing potential must have a negative...
- Adequate contraception includes sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap...
- Intellectual deficiency not allowing full filling of NPSI.
- Insufficient command of the French language to full fill NPSI and other evaluation tools.
- Parents' refusal of consent.
- Minor patients' opposition.
- Underlying neurological disease.
- Ongoing neurotoxic treatment.
- Already treated by capsaicin.
- Cutaneous lesion on pain area.
- Patient presenting a pain area on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Qutenza SmPC.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Bordeaux, France
- Brest, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Tours, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Bordeaux, France; Brest, France; Lyon, France; Marseille, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.