Botulinum Toxin in Peripheral Neuropathic Pain
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Purpose
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. 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 and b/ evaluate its mechanisms of action. This will be a randomized placebo controlled study. A total of 40 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postherpetic Neuralgia Diabetic Polyneuropathies Other Polyneuropathies |
Drug: botulinum toxin type A |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
- Average pain intensity on numerical scales in a self diary by the patient [ Time Frame: every day from baseline for up to 6 months ] [ Designated as safety issue: No ]Numerical scales (0-10)
- Efficacy of treatment on neuropathic symptoms [ Time Frame: at each visit ] [ Designated as safety issue: No ]Neuropathic Pain Symptom Inventory will be used to assess symptoms
- Affective and sensory components of pain [ Time Frame: at each visit ] [ Designated as safety issue: No ]This will be assessed using the Short Form Mc Gill pain questionnaire
- Quality of life [ Time Frame: at each visit ] [ Designated as safety issue: No ]This will be assessed using the EuroQol questionnaire
- Intensity and area of allodynia to brush [ Time Frame: at each visit ] [ Designated as safety issue: No ]This will performed using a brush
- assessment of effects of BTX-A on substance P, CGRP and TRPVA receptors [ Time Frame: at baseline and 1 month after BTX-A or placebo ] [ Designated as safety issue: No ]This will be performed using skin punch biopsies in the painful area
- Side effects [ Time Frame: throughout the study and each each visit ] [ Designated as safety issue: No ]side effects of BTX-A will be assessed
- Detection and pain thresholds to mechanical and thermal stimuli [ Time Frame: at each visit ] [ Designated as safety issue: No ]this will use quantitative sensory testing (thermotest, Von Frey filaments)
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: botulinum toxin type A
botulinum toxin type A will be injected subcutaneously in the painful area (maximum 300 units)
|
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
Other Name: botox
|
|
Placebo Comparator: sodium chloride 9 %
sodium chloride 9 % will be used as a neutral placebo
|
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
Other Name: botox
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Brazil | |
| Divisão de Clínica Neurológica do Hospital das Clínicas da FMUSP | Recruiting |
| Sao Paulo, Brazil | |
| Contact: Daniel CIAMPI, MD PhD +55 11 26 61 71 52 ciampi@usp.br | |
| Principal Investigator: Daniel Ciampi de Andrade, MD PhD | |
| Sub-Investigator: Ricardo MACARENcO, MD | |
| Sub-Investigator: Irina RAICHER | |
| France | |
| Hôpital Ambroise Paré, APHP | Recruiting |
| Boulogne-Billancourt, France, 92100 | |
| Contact: Nadine ATTAL, MD PhD 00033149094434 nadine.attal@apr.aphp.fr | |
| Principal Investigator: Nadine ATTAL | |
| Sub-Investigator: Frédéric ADAM, MD PhD | |
| Hôpital Dupuytren | Recruiting |
| Limoges, France | |
| Contact: Danièle RANOUX, MD daniele.ranoux@aol.com | |
| Principal Investigator: Danièle RANOUX, MD | |
| Study Director: | Nadine ATTAL, MD PhD | APHP and INSERM |
More Information
No publications provided
| Responsible Party: | Nadine ATTAL, Clinical principal investigator, Hôpital Ambroise Paré |
| ClinicalTrials.gov Identifier: | NCT01251211 History of Changes |
| Other Study ID Numbers: | BOTNEP |
| Study First Received: | November 30, 2010 |
| Last Updated: | August 21, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes France: Direction Générale de la Santé |
Keywords provided by Hôpital Ambroise Paré:
|
BOTULINUM TOXIN NEUROPATHIC PAIN RANDOMIZED CONTROLLED TRIAL |
Additional relevant MeSH terms:
|
Botulinum Toxins, Type A Botulinum Toxins Neuralgia Neuralgia, Postherpetic Polyneuropathies Diabetic Neuropathies Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |
Signs and Symptoms Diabetes Complications Diabetes Mellitus Endocrine System Diseases Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013