Botulinum Toxin in Peripheral Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nadine ATTAL, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier:
NCT01251211
First received: November 30, 2010
Last updated: January 7, 2014
Last verified: January 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. 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 and b/ evaluate its mechanisms of action. 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 Hôpital Ambroise Paré:

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)


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
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
Hôpital Ambroise Paré
Investigators
Study Director: Nadine ATTAL, MD PhD APHP and INSERM
  More Information

No publications provided

Responsible Party: Nadine ATTAL, Clinical principal investigator, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier: NCT01251211     History of Changes
Other Study ID Numbers: BOTNEP
Study First Received: November 30, 2010
Last Updated: January 7, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Direction Générale de la Santé

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

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

ClinicalTrials.gov processed this record on April 14, 2014