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NCT00527202 Clinical Trial

Efficacy Study of Botox to Treat Neuropathic Pain

Postherpetic Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00527202
Other study ID # BTXneurop-1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2004
Est. completion date March 2007

Study information
Verified date April 2021
Source Hospital Ambroise Paré Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• botulinum toxin A
Botulinum toxin A versus saline in parallel groups

Locations
Country Name City State
France Hôpital Ambroise Paré, AP-HP Boulogne-billancourt

Sponsors (1)
Lead Sponsor Collaborator
Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Self-reported pain (numerical scales) on patients diaries pain intensity on numerical rating scales prospective
Secondary mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness VAS for pain intensity prospective
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