Clinical trial NCT01251211: Botulinum Toxin in Peripheral Neuropathic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postherpetic Neuralgia
Diabetic Polyneuropathies
Other Polyneuropathies
Keywords: BOTULINUM TOXIN
NEUROPATHIC PAIN
RANDOMIZED CONTROLLED TRIAL
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average pain intensity on numerical scales in a self diary by the patient
timeFrame: every day from baseline for up to 6 months
Secondary outcomes:
measure: Efficacy of treatment on neuropathic symptoms
timeFrame: at each visit
measure: Quality of life VAS
timeFrame: at each visit
measure: Intensity of allodynia to brush
timeFrame: at each visit
measure: assessment of effects of BTX-A on substance P and CGRP
timeFrame: at baseline and 1 month after BTX-A or placebo
measure: Side effects
timeFrame: throughout the study and each each visit
measure: Detection and pain thresholds to mechanical and thermal stimuli and responses to suprathreshold stimuli
timeFrame: at each visit
measure: Predictors of the response
timeFrame: Up to 6 months
Other outcomes:
measure: Evaluate the therapeutic gain of the second injection
timeFrame: Throughout the study up to 6 months
measure: Evaluate pain relief at 24 weeks
timeFrame: 24 weeks
Locations:
city: Sao Paulo
country: Brazil
facility: Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré, APHP
city: Limoges
country: France
facility: Hôpital Dupuytren
Study officials:
affiliation: APHP and INSERM
name: Nadine ATTAL, MD PhD
role: STUDY_DIRECTOR
References:
citation: Attal N, de Andrade DC, Adam F, Ranoux D, Teixeira MJ, Galhardoni R, Raicher I, Uceyler N, Sommer C, Bouhassira D. Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2016 May;15(6):555-65. doi: 10.1016/S1474-4422(16)00017-X. Epub 2016 Mar 2.