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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01251211
Other study ID # BOTNEP
Secondary ID
Status Completed
Phase Phase 4
First received November 30, 2010
Last updated March 10, 2016
Start date October 2010
Est. completion date January 2014

Study information

Verified date March 2016
Source Hospital Ambroise Paré Paris
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Direction Générale de la Santé
Study type Interventional

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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

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 Criteria:

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

Study Design

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


Intervention

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

Locations

Country Name City State
Brazil Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP Sao Paulo
France Hôpital Ambroise Paré, APHP Boulogne-Billancourt
France Hôpital Dupuytren Limoges

Sponsors (1)

Lead Sponsor Collaborator
Hospital Ambroise Paré Paris

Countries where clinical trial is conducted

Brazil,  France, 

Outcome

Type Measure Description Time frame Safety issue
Other Evaluate the therapeutic gain of the second injection Evaluate whether the second injection is associated with significant therapeutic gain on average pain intensity over 6 months Throughout the study up to 6 months No
Other Evaluate pain relief at 24 weeks pain relief scale 24 weeks No
Primary Average pain intensity on numerical scales in a self diary by the patient Numerical scales (0-10) every day from baseline for up to 6 months No
Secondary Efficacy of treatment on neuropathic symptoms Neuropathic Pain Symptom Inventory will be used to assess symptoms at each visit No
Secondary Quality of life VAS This will be assessed using the EuroQol questionnaire at each visit No
Secondary Intensity of allodynia to brush This will performed using a brush at each visit No
Secondary assessment of effects of BTX-A on substance P and CGRP This will be performed using skin punch biopsies in the painful area at baseline and 1 month after BTX-A or placebo No
Secondary Side effects side effects of BTX-A will be assessed throughout the study and each each visit No
Secondary Detection and pain thresholds to mechanical and thermal stimuli and responses to suprathreshold stimuli this will use quantitative sensory testing (thermotest, Von Frey filaments) at each visit No
Secondary Predictors of the response We will assess the predictors of the response to BTX-A based on baseline pain thresholds, presence and severity of allodynia, skin punch biopsy and catastrophizing Up to 6 months No
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