Peripheral Neuropathic Pain Clinical Trial
— CAPSICAURAOfficial title:
Response Profiles to High-concentration Capsaicin Desensitization in Patients With Peripheral Neuropathic Pain With or Without Allodynia: a Regional Multicenter Prospective Cohort
NCT number | NCT05817591 |
Other study ID # | 19-50 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 14, 2023 |
Est. completion date | June 15, 2026 |
Prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the Auvergne Rhône Alpes region.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | June 15, 2026 |
Est. primary completion date | June 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient over 18 years of age on the day of inclusion - Patient who has been informed and has not expressed opposition to participating in the study, - Patient with peripheral neuropathic pain (whatever the etiology), defined by : - "Neuropathic Pain 4" score ("DN4" score) = 4/10 - AND pain according to the numerical scale (EN) > 4/10, - AND stable analgesic treatment for at least 1 month, - AND with or without mechanical allodynia according to the Quantitative Sensory Testing (QST) : Brush test (dynamic), Von Frey test (static) - AND with or without thermal allodynia to hot or cold as determined by a ROLLTEMP-II® (Rolltemp is a device designed for quick screening of temperature sensibility over large body areas). - Patient responding to an indication of desensitization to high concentration capsaicin concentration and not presenting any contra-indication. - Patient naïve of high concentration of Capsaicin on the concerned zone - Patient understanding French Non-inclusion Criteria: - Patient with pain related to complex regional pain syndrome (criteria not meeting the indication for capsaicin) - Patient with active cancer (underlying disease and treatments may modify pain perception), - Patient receiving or having received in the last 3 months Botulinum toxin A on the concerned area (this treatment of neuropathic pain may modulate the effect of capsaicin and disturb the demonstration of causality), - Patient with planned surgery within the next 12 months on the painful site (surgery may cause neuropathic damage and/or bias the pain assessment), - Patient included in an interventional research protocol, - Patient under guardianship or curators, - Patient under legal protection Exclusion Criteria: None |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Annecy Genevois | Annecy | |
France | Hospices Civils de Lyon, Hôpital Pierre Wertheimer | Bron | |
France | Centre Hospitalier Métropole Savoie | Chambéry | |
France | Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | |
France | Centre Hospitalier Universitaire Grenoble-Alpes | Grenoble | |
France | Centre Léon Bérard | Lyon | |
France | Hospices Civils de Lyon, Hôpital de la Croix Rousse | Lyon | |
France | Centre Hospitalier Universitaire de Saint-Etienne | Saint-Étienne | |
France | Clinique Mutualiste Chirurgicale de Saint Etienne | Saint-Étienne | |
France | Médipôle Lyon Villeurbanne | Villeurbanne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Annecy Genevois |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Factors (profiles) associated with a better initial response to pain desensitization by capsaicin | A patient is a responder if he has a reduction in pain, as measured by a numerical pain scale, of at least 30% from baseline. The scale used is "EN - échelle numérique" in french, "NRS - Numerical Rating Scale" in english, between 0 and 10 (0 being the absence of pain and 10 the most intense pain). | 12 months | |
Secondary | Proportion [95% Confidence Interval (CI)] of patients "responder at 30%" at 1.5 months after each consecutive patch (e.g. at M4.5 for a second patch applied at M3) | 1.5 months after each consecutive patch | ||
Secondary | Proportion [95% CI] of patients "initial responder" at 50% | 12 months | ||
Secondary | Distribution of Neuropathic Pain Symptom Inventory (NPSI) score values over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up | The NPSI scale is composed of 12 questions (10 descriptive questions of symptoms and 2 to evaluate the frequency and duration of pain). The score for the descriptive questions is between 0 and 100 (0 being the absence of pain and 10 the most intense pain). | Each 3 months and over 12 months | |
Secondary | Distribution of NPSI subscores values (Q8, Q9, Q10) over time: at inclusion, 3 months, 6 months, 9 months,12 months, and between inclusion and the end of follow-up | Each 3 months and over 12 months | ||
Secondary | Distribution of Patients' Global Impression of Change (PGIC) scale score values over time: at 1.5 months, 3 months, 4.5 months, 6 months, 7.5 months, 9 months,10.5 months, 12 months, and between inclusion and the end of follow-up | The Patients' Global Impression of Change (PGIC) scale describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life. It is between 1 and 7 (1 being no change or conditions has got worse, and 7 is a great deal better and a considerable improvement that as made all the difference). | Each 1.5 months and over 12 months | |
Secondary | In the subpopulation of patients with allodynia (dynamic mechanical or static or thermal): proportion [95% CI] of "responders" at 7.5 months | 7.5 months | ||
Secondary | In the subpopulation of initial responders at the 30% threshold: proportion [95% CI] of patients relapsing at 12 months, defined as pain scale (EN) > 4/10, indicating a new capsaicin patch | 12 months | ||
Secondary | Number of new initiation of analgesic treatment, defined by the addition of a molecule to the treatment given at the time of application of the first capsaicin patch | 12 months | ||
Secondary | Number of reduction of analgesic treatment, defined by the stop of a molecule compared to the treatment given at the time of the application of the first capsaicin patch | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03733886 -
Burst Spinal Cord Stimulation for Neuropathic Pain.
|
N/A | |
Completed |
NCT04494815 -
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
|
Phase 1/Phase 2 | |
Recruiting |
NCT04431778 -
Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
|
Phase 2 | |
Completed |
NCT03191136 -
Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02100046 -
Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
|
Phase 2 | |
Completed |
NCT05416931 -
ACD440 Gel in Peripheral Neuropathic Pain
|
Phase 2 | |
Completed |
NCT06234917 -
Increasing Sensori-Motor Rhythm Activity by EEG-Neurofeedback to Reduce the Impact of Pain on Daily Functioning
|
N/A | |
Completed |
NCT03009500 -
Randomized Controlled Trial of Efficacy and Safety of Local Anesthetics and Steroids for Chronic Peripheral Post-traumatic Neuropathic Pain
|
Phase 3 | |
Completed |
NCT01524796 -
NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark
|
||
Completed |
NCT02985216 -
Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain
|
Phase 3 | |
Recruiting |
NCT04171453 -
Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets
|
||
Completed |
NCT01737294 -
Observation of the Use of QUTENZA™ in Standard Clinical Practice
|
N/A | |
Active, not recruiting |
NCT05890053 -
To Evaluate the Long-term Safety and Efficacy of HSK16149 in Chinese Patients With Peripheral Neuralgia
|
Phase 3 | |
Completed |
NCT05219812 -
A Study to Learn How Safe BAY2395840 is and How Well it Works in Participants Who Have Diabetic Nerve Pain
|
Phase 2 | |
Terminated |
NCT01293851 -
Molecular-Genetic Mechanisms Associated With Chemotherapy-Induced Nerve Damage
|
||
Completed |
NCT02209896 -
BlueWind Reprieve System for the Treatment of PNP
|
N/A | |
Completed |
NCT01240148 -
Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers
|
Phase 1 |