NCT00527202

Efficacy Study of Botox to Treat Neuropathic Pain

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Hospital Ambroise Paré Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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.

Conditions

• Postherpetic Neuralgia
• Nerve Trauma

Interventions

Type	Name	Description
DRUG	botulinum toxin A	Botulinum toxin A versus saline in parallel groups

Timeline

• Start date: 2004-06-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2007-09-10
• Last updated: 2021-05-05

Locations

1 site across 1 country: France