Botulinum Toxin in Peripheral Neuropathic Pain

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01251211
Study type	Interventional
Source	Hospital Ambroise Paré Paris
Contact
Status	Completed
Phase	Phase 4
Start date	October 2010
Completion date	January 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04546334` - Erector Spinae Plane Block in Post-herpetic Neuralgia	N/A
Completed	`NCT01688947` - Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)	Phase 2
Terminated	`NCT01744522` - Leech Therapy for Postherpetic Neuralgia	N/A
Completed	`NCT00478179` - Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia	Phase 2
Completed	`NCT00566904` - New Topical Treatment for Continued Pain After Shingles	Phase 1
Completed	`NCT04099706` - Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT	N/A
Terminated	`NCT01603394` - Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia	Phase 4
Completed	`NCT01228838` - Study of NGX-1998 for the Treatment of Postherpetic Neuralgia	Phase 2
Completed	`NCT00612105` - Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)	Phase 2
Recruiting	`NCT04560361` - The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia	N/A
Recruiting	`NCT05568186` - Correlation Between Thermal Patterns of Infrared Thermal Imaging and Clinical Phenotype in Patients With Postherpetic Neuralgia
Recruiting	`NCT04664530` - The Study on the Esketamine in the Treatment of Postherpetic Neuralgia	Phase 4
Active, not recruiting	`NCT01508676` - Effects of Pennsaid on Clinical Neuropathic Pain	N/A
Completed	`NCT00885586` - Acupuncture in Herpes Zoster Neuralgia (ACUZoster)	Phase 4
Completed	`NCT00981227` - Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia	Phase 2
Completed	`NCT00576108` - A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)	Phase 2
Completed	`NCT00238511` - An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN)	Phase 2
Completed	`NCT00007501` - Shingles Prevention Study	Phase 3
Completed	`NCT04594226` - Electroacupuncture Therapy for Treating Postherpetic Neuralgia	N/A
Completed	`NCT05140863` - To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia	Phase 3