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Efficacy Study of Botox to Treat Neuropathic Pain

Sponsor
Hospital Ambroise Paré Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00527202
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
33
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: botulinum toxin A
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Self-reported pain (numerical scales) on patients diaries [prospective]

      pain intensity on numerical rating scales

    Secondary Outcome Measures

    1. mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness [prospective]

      VAS for pain intensity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Ambroise Paré, AP-HP Boulogne-billancourt France 92100f

    Sponsors and Collaborators

    • Hospital Ambroise Paré Paris

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nadine ATTAL, MD PhD coordinator, Hospital Ambroise Paré Paris
    ClinicalTrials.gov Identifier:
    NCT00527202
    Other Study ID Numbers:
    • BTXneurop-1
    First Posted:
    Sep 10, 2007
    Last Update Posted:
    May 5, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Neuralgia
    Neuralgia, Postherpetic
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of May 5, 2021