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NCT Number: NCT01251211

Botulinum Toxin in Peripheral Neuropathic Pain

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.

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Key information

Conditions

Postherpetic Neuralgia Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Polyneuropathies Endocrine System Diseases Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Other Polyneuropathies Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

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

Other names: botox

Primary outcomes

  1. Average pain intensity on numerical scales in a self diary by the patient

    Time frame: every day from baseline for up to 6 months

    Numerical scales (0-10)

Secondary outcomes

  1. Efficacy of treatment on neuropathic symptoms

    Time frame: at each visit

    Neuropathic Pain Symptom Inventory will be used to assess symptoms

  2. Quality of life VAS

    Time frame: at each visit

    This will be assessed using the EuroQol questionnaire

  3. Intensity of allodynia to brush

    Time frame: at each visit

    This will performed using a brush

  4. assessment of effects of BTX-A on substance P and CGRP

    Time frame: at baseline and 1 month after BTX-A or placebo

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

  5. Side effects

    Time frame: throughout the study and each each visit

    side effects of BTX-A will be assessed

  6. Detection and pain thresholds to mechanical and thermal stimuli and responses to suprathreshold stimuli

    Time frame: at each visit

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

  7. Predictors of the response

    Time frame: Up 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

Other outcomes

  1. Evaluate the therapeutic gain of the second injection

    Time frame: Throughout the study up to 6 months

    Evaluate whether the second injection is associated with significant therapeutic gain on average pain intensity over 6 months

  2. Evaluate pain relief at 24 weeks

    Time frame: 24 weeks

    pain relief scale

Sponsors and collaborators

Lead sponsor

Hospital Ambroise Paré Paris

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 1, 2010
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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