Efficacy Study of Botox to Treat Neuropathic Pain

April 29, 2021 updated by: Nadine ATTAL, Hospital Ambroise Paré Paris

Randomized Placebo-controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia

Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-billancourt, France, 92100f
        • Hôpital Ambroise Paré, AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion
  • limited area of pain
  • mechanical allodynia in the painful area

Exclusion Criteria:

  • contraindication to BTXA formulation
  • coagulation disorders
  • another painful condition
  • current major depression
  • history of drug or alcohol abuse
  • compensation claim or litigation
  • facial neuropathic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: botulinum toxin A
active treatment arm using botulinum toxin A max 200 U injected into the painful area using SC injections 2 cm apart
Drug: botulinum toxin A
Botulinum toxin A versus saline in parallel groups
Other Names:
  • saline (placebo)
Placebo Comparator: placebo
saline injection with the same dosages injected using the same procedure as botulinum toxin A
Drug: botulinum toxin A
Botulinum toxin A versus saline in parallel groups
Other Names:
  • saline (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported pain (numerical scales) on patients diaries
Time Frame: prospective
pain intensity on numerical rating scales
prospective

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness
Time Frame: prospective
VAS for pain intensity
prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ambroise Paré Paris

Investigators

  • Study Director: Didier BOUHASSIRA, MD, PHD, INSERM U 792
  • Study Chair: Danièle RANOUX, MD, hôpital de Limoges (FRANCE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTXneurop-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postherpetic Neuralgia

Clinical Trials on botulinum toxin A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe