NCT01251211

Botulinum Toxin in Peripheral Neuropathic Pain

Randomized Double Blind Placebo Controlled Multicenter Study of the Efficacy and Safety of Repeated Administrations of Botulinum Toxin Type A (Botox) in the Treatment of Peripheral Neuropathic Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hospital Ambroise Paré Paris · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Pain due to peripheral nerve lesion remains extremely difficult to treat and current treatments have onl moderate efficacy and/or side effects. The investigators have previously demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second injection is associated with a therapeutic gain. This will be a randomized placebo controlled study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous injection in the painful area) or placebo. Each injection will be repeated within at least 3 months depending on the duration of efficacy. Skin punch biopsies will be performed before and 1 month after BTX-A administration. The investigators postulate that this study will confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the treatment of peripheral neuropathic pain.

Conditions

• Postherpetic Neuralgia
• Diabetic Polyneuropathies
• Other Polyneuropathies

Interventions

Type	Name	Description
DRUG	botulinum toxin type A	BTX A : 5 units/0.2 ml, maximum 300 units will be injected subcutaneous in the painful area ; this will be performed after randomization and within a minimum of 3 months interval depending on the duration of efficacy (maximum 6 months) Saline will be injected in the same volume in the painful area within the same frequency

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-12-01
• Last updated: 2016-03-11

Locations

3 sites across 2 countries: Brazil, France