Status:
COMPLETED
Botulinum Toxin in Peripheral Neuropathic Pain
Lead Sponsor:
Hospital Ambroise Paré Paris
Conditions:
Postherpetic Neuralgia
Diabetic Polyneuropathies
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- Men or women aged 18 to 85 years Spontaneous pain with a minimal intensity of 4/10 on numerical scle Pain present for at least 6 months Pain related to painful mononeuropathy or sensory polyneuropathy Able to understand the protocol and comply to the requirements of the study Written informed consent Painful area limited to a maximum of 240 cm2
Exclusion
- Facial pain Litigation (pending) Unstable condition responsible for neuropathic pain (ie, unstable immunological disease...) HIV or chemotherapy induced neuropathy Contraindications to BTX-A (neuromuscular disease, hypersensitivity, infection, coagulation disorder, pregnancy) Other pain more severe than neuropathic pain No compliance with the self diary Drug abuse or alcoholism Severe major depression Cognitive impairment Other research protocol within the last 30 days
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01251211
Start Date
October 1 2010
End Date
January 1 2014
Last Update
March 11 2016
Active Locations (3)
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1
Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil
2
Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, France, 92100
3
Hôpital Dupuytren
Limoges, France