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Botulinum Toxin in Peripheral Neuropathic Pain

Phase 4
Completed
Conditions
Postherpetic Neuralgia
Diabetic Polyneuropathies
Other Polyneuropathies
Interventions
Registration Number
NCT01251211
Lead Sponsor
Hospital Ambroise Paré Paris
Brief Summary

Pain due to peripheral nerve lesion remains extremely difficult to treat and current treatments have onl moderate efficacy and/or side effects. The investigators have previously demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second injection is associated with a therapeutic gain. This will be a randomized placebo controlled study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous injection in the painful area) or placebo. Each injection will be repeated within at least 3 months depending on the duration of efficacy. Skin punch biopsies will be performed before and 1 month after BTX-A administration. The investigators postulate that this study will confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the treatment of peripheral neuropathic pain.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
66
Inclusion Criteria

Men or women aged 18 to 85 years Spontaneous pain with a minimal intensity of 4/10 on numerical scle Pain present for at least 6 months Pain related to painful mononeuropathy or sensory polyneuropathy Able to understand the protocol and comply to the requirements of the study Written informed consent Painful area limited to a maximum of 240 cm2

Exclusion Criteria

Facial pain Litigation (pending) Unstable condition responsible for neuropathic pain (ie, unstable immunological disease...) HIV or chemotherapy induced neuropathy Contraindications to BTX-A (neuromuscular disease, hypersensitivity, infection, coagulation disorder, pregnancy) Other pain more severe than neuropathic pain No compliance with the self diary Drug abuse or alcoholism Severe major depression Cognitive impairment Other research protocol within the last 30 days

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
botulinum toxin type Abotulinum toxin type Abotulinum toxin type A will be injected subcutaneously in the painful area (maximum 300 units)
sodium chloride 9 %botulinum toxin type Asodium chloride 9 % will be used as a neutral placebo
Primary Outcome Measures
NameTimeMethod
Average pain intensity on numerical scales in a self diary by the patientevery day from baseline for up to 6 months

Numerical scales (0-10)

Secondary Outcome Measures
NameTimeMethod
Efficacy of treatment on neuropathic symptomsat each visit

Neuropathic Pain Symptom Inventory will be used to assess symptoms

Quality of life VASat each visit

This will be assessed using the EuroQol questionnaire

Intensity of allodynia to brushat each visit

This will performed using a brush

assessment of effects of BTX-A on substance P and CGRPat baseline and 1 month after BTX-A or placebo

This will be performed using skin punch biopsies in the painful area

Side effectsthroughout the study and each each visit

side effects of BTX-A will be assessed

Detection and pain thresholds to mechanical and thermal stimuli and responses to suprathreshold stimuliat each visit

this will use quantitative sensory testing (thermotest, Von Frey filaments)

Predictors of the responseUp to 6 months

We will assess the predictors of the response to BTX-A based on baseline pain thresholds, presence and severity of allodynia, skin punch biopsy and catastrophizing

Trial Locations

Locations (3)

Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP

🇧🇷

Sao Paulo, Brazil

Hôpital Ambroise Paré, APHP

🇫🇷

Boulogne-Billancourt, France

Hôpital Dupuytren

🇫🇷

Limoges, France

Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP
🇧🇷Sao Paulo, Brazil

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