Botulinum Toxin in Peripheral Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nadine ATTAL, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier:
NCT01251211
First received: November 30, 2010
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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 and b/ evaluate its mechanisms of action ; c/compare the effects of BTX-A in allodynic and nonallodynic patients. This will be a randomized placebo controlled study. A total of 40 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.


Condition Intervention Phase
Postherpetic Neuralgia
Diabetic Polyneuropathies
Other Polyneuropathies
Drug: botulinum toxin type A
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hospital Ambroise Paré Paris:

Primary Outcome Measures:
  • Average pain intensity on numerical scales in a self diary by the patient [ Time Frame: every day from baseline for up to 6 months ] [ Designated as safety issue: No ]
    Numerical scales (0-10)


Secondary Outcome Measures:
  • Efficacy of treatment on neuropathic symptoms [ Time Frame: at each visit ] [ Designated as safety issue: No ]
    Neuropathic Pain Symptom Inventory will be used to assess symptoms

  • Affective and sensory components of pain [ Time Frame: at each visit ] [ Designated as safety issue: No ]
    This will be assessed using the Short Form Mc Gill pain questionnaire

  • Quality of life [ Time Frame: at each visit ] [ Designated as safety issue: No ]
    This will be assessed using the EuroQol questionnaire

  • Intensity and area of allodynia to brush [ Time Frame: at each visit ] [ Designated as safety issue: No ]
    This will performed using a brush

  • assessment of effects of BTX-A on substance P, CGRP and TRPVA receptors [ Time Frame: at baseline and 1 month after BTX-A or placebo ] [ Designated as safety issue: No ]
    This will be performed using skin punch biopsies in the painful area

  • Side effects [ Time Frame: throughout the study and each each visit ] [ Designated as safety issue: No ]
    side effects of BTX-A will be assessed

  • Detection and pain thresholds to mechanical and thermal stimuli [ Time Frame: at each visit ] [ Designated as safety issue: No ]
    this will use quantitative sensory testing (thermotest, Von Frey filaments)

  • Predictors of the response [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    We will assess the predictors of the response to BTX-A based on baseline pain thresholds, severity of allodynia, skin punch biopsy and catastrophizing


Other Outcome Measures:
  • Evaluate the effects of botulinum toxin in patients with allodynia as compared to those without [ Time Frame: Throughout the study up to 6 months ] [ Designated as safety issue: No ]
    A subgroup of patients only is expected to have mechanical allodynia ; here we aim to determine if BTX has similar or distinct effects in patients with and without allodynia, since our prior study had explored only patients with mechanical allodynia.


Enrollment: 60
Study Start Date: October 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: botulinum toxin type A
botulinum toxin type A will be injected subcutaneously in the painful area (maximum 300 units)
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
Other Name: botox
Placebo Comparator: sodium chloride 9 %
sodium chloride 9 % will be used as a neutral placebo
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
Other Name: botox

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251211

Locations
Brazil
Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP
Sao Paulo, Brazil
France
Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, France, 92100
Hôpital Dupuytren
Limoges, France
Sponsors and Collaborators
Hospital Ambroise Paré Paris
Investigators
Study Director: Nadine ATTAL, MD PhD APHP and INSERM
  More Information

No publications provided

Responsible Party: Nadine ATTAL, Clinical principal investigator, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier: NCT01251211     History of Changes
Other Study ID Numbers: BOTNEP
Study First Received: November 30, 2010
Last Updated: May 12, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Direction Générale de la Santé

Keywords provided by Hospital Ambroise Paré Paris:
BOTULINUM TOXIN
NEUROPATHIC PAIN
RANDOMIZED CONTROLLED TRIAL

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Neuralgia, Postherpetic
Polyneuropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014