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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00527202

Enrollment

Registered

2007-09-10

Start date

2004-06-30

Completion date

2007-03-31

Last updated

2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Trauma, Postherpetic Neuralgia

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)

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.

Interventions

DRUGbotulinum toxin A

Botulinum toxin A versus saline in parallel groups

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026