NCT05299294

Brief Summary

Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study . Medical data will be recorded and at home, the child or his family will collect pain assessment data. Tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
May 2022Sep 2027

First Submitted

Initial submission to the registry

December 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 12, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

5 years

First QC Date

December 23, 2021

Last Update Submit

July 29, 2026

Conditions

Neuropathic PainChronic Pain

Keywords

Neuropathic PainPediatricCapsaicin

Outcome Measures

Primary Outcomes (1)

  • Success or failure of pain treatment

    The success is defined by the absence of use of pharmacological or non-pharmacological treatments taken for pain relief or to improve comfort, including to aid sleep, 6 months after capsaicin last patch application. The list of treatments is defined as follows: antiepileptic drug, tricyclic antidepressant, SNRI antidepressant, weak opioids, strong opioids, other pharmacological treatments, non-pharmacological pain-related devices.

    6 months after last patch application

Secondary Outcomes (37)

  • Use of pharmacological treatment

    Baseline

  • Use of pharmacological treatment

    6 months after last patch application

  • Use of antiepileptic treatment

    Baseline

  • Use of antiepileptic treatment

    6 months after last patch application

  • Use of tricyclic antidepressant treatment

    Baseline

  • +32 more secondary outcomes

Interventions

Data collectionOTHER

Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients aged less than 18-y with chronic localized neuropathic pain and capsaicin 8% patch indication validated in a pediatric chronic pain center. patient with intellectual development disabilities are accepted

You may qualify if:

  • chronic localized neuropathic pain
  • capsaicin 8% patch treatment indication validated in a pediatric chronic pain center
  • agreement for participation by child and parents

You may not qualify if:

  • already treated with capsaicin 8% patch in the same body area
  • already treated in the same study in an other investigation center
  • non willing to participate or parents not willing participation to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CHU Angers

Angers, France, 49933, France

Location

CHU Bordeaux

Bordeaux, France, 33076, France

Location

CHR Bourg en Bresse

Bourg-en-Bresse, France, 01000, France

Location

CHU de Brest

Brest, France, 29609, France

Location

CHU Caen

Caen, France, 14000, France

Location

CHU Lille

Lille, France, 59037, France

Location

CHU Limoges

Limoges, France, 87042, France

Location

CHU Marseille

Marseille, France, 13005, France

Location

CHU Montpellier

Montpellier, France, 34090, France

Location

CHU Nancy

Nancy, France, 54511, France

Location

CHU Nantes

Nantes, France, 44093, France

Location

CHU Robert Debré

Paris, France, 75019, France

Location

CHU Trousseau

Paris, France, 75571, France

Location

CHU Rouen

Rouen, France, 76031, France

Location

CHRU Strasbourg

Strasbourg, France, 67098, France

Location

CHU Toulouse

Toulouse, France, 31059, France

Location

CHU Tours

Tours, France, 37044, France

Location

Institut Gustave Roussy

Villejuif, France, 94805, France

Location

CHU d'Amiens

Amiens, 80054, France

Location

CHU Lyon

Lyon, France

Location

MeSH Terms

Conditions

NeuralgiaChronic Pain

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Philippe J Le Moine, MD

    CHRU of Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

March 29, 2022

Study Start

May 12, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations

FR(20)