Botulinum Toxin in Peripheral Neuropathic Pain

Postherpetic Neuralgia Clinical Trial

Official title:

Randomized Double Blind Placebo Controlled Multicenter Study of the Efficacy and Safety of Repeated Administrations of Botulinum Toxin Type A (Botox) in the Treatment of Peripheral Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251211
• Other study ID #: BOTNEP
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2010
• Last updated: March 10, 2016
• Start date: October 2010
• Est. completion date: January 2014

Study information

• Verified date: March 2016
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathies
• Neuralgia
• Neuralgia, Postherpetic
• Other Polyneuropathies
• Polyneuropathies
• Postherpetic Neuralgia

Intervention

Drug:
• botulinum toxin type A
BTX A : 5 units/0.2 ml, maximum 300 units will be injected subcutaneous in the painful area ; this will be performed after randomization and within a minimum of 3 months interval depending on the duration of efficacy (maximum 6 months) Saline will be injected in the same volume in the painful area within the same frequency

Locations

Country	Name	City	State
Brazil	Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP	Sao Paulo
France	Hôpital Ambroise Paré, APHP	Boulogne-Billancourt
France	Hôpital Dupuytren	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris

Countries where clinical trial is conducted

Brazil,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the therapeutic gain of the second injection	Evaluate whether the second injection is associated with significant therapeutic gain on average pain intensity over 6 months	Throughout the study up to 6 months	No
Other	Evaluate pain relief at 24 weeks	pain relief scale	24 weeks	No
Primary	Average pain intensity on numerical scales in a self diary by the patient	Numerical scales (0-10)	every day from baseline for up to 6 months	No
Secondary	Efficacy of treatment on neuropathic symptoms	Neuropathic Pain Symptom Inventory will be used to assess symptoms	at each visit	No
Secondary	Quality of life VAS	This will be assessed using the EuroQol questionnaire	at each visit	No
Secondary	Intensity of allodynia to brush	This will performed using a brush	at each visit	No
Secondary	assessment of effects of BTX-A on substance P and CGRP	This will be performed using skin punch biopsies in the painful area	at baseline and 1 month after BTX-A or placebo	No
Secondary	Side effects	side effects of BTX-A will be assessed	throughout the study and each each visit	No
Secondary	Detection and pain thresholds to mechanical and thermal stimuli and responses to suprathreshold stimuli	this will use quantitative sensory testing (thermotest, Von Frey filaments)	at each visit	No
Secondary	Predictors of the response	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	Up to 6 months	No