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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Nerve Trauma
• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

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