Efficacy Study of Botox to Treat Neuropathic Pain

Hospital Ambroise Paré Paris

Status and phase: Completed; Phase 4

Conditions: Postherpetic Neuralgia; Nerve Trauma

Treatments: Drug: botulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT00527202

BTXneurop-1

Details and patient eligibility

About

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)

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

botulinum toxin A

Experimental group

Description:

active treatment arm using botulinum toxin A max 200 U injected into the painful area using SC injections 2 cm apart

Treatment:

Drug: botulinum toxin A

placebo

Placebo Comparator group

Description:

saline injection with the same dosages injected using the same procedure as botulinum toxin A

Treatment:

Drug: botulinum toxin A