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Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial

INTRODUCTION: Currently available analgesics are ineffective in 30–50% of patients suffering from neuropathic pain and often induce deleterious side effects. T-type calcium channel blockers (mibefradil, ethosuximide, NNC 55-0396) are of great interest for the development of new symptomatic treatment...

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Autores principales: Kerckhove, Nicolas, Mallet, Christophe, Pereira, Bruno, Chenaf, Chouki, Duale, Christian, Dubray, Claude, Eschalier, Alain
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5168699/
https://www.ncbi.nlm.nih.gov/pubmed/27986742
http://dx.doi.org/10.1136/bmjopen-2016-013530
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author Kerckhove, Nicolas
Mallet, Christophe
Pereira, Bruno
Chenaf, Chouki
Duale, Christian
Dubray, Claude
Eschalier, Alain
author_facet Kerckhove, Nicolas
Mallet, Christophe
Pereira, Bruno
Chenaf, Chouki
Duale, Christian
Dubray, Claude
Eschalier, Alain
author_sort Kerckhove, Nicolas
collection PubMed
description INTRODUCTION: Currently available analgesics are ineffective in 30–50% of patients suffering from neuropathic pain and often induce deleterious side effects. T-type calcium channel blockers (mibefradil, ethosuximide, NNC 55-0396) are of great interest for the development of new symptomatic treatments of neuropathic pain, due to their various effects on pain perception. Interestingly, ethosuximide, which has already been approved for treating epilepsy, is available on the European market for clinical use. Despite numerous preclinical data demonstrating an antinociceptive effect of ethosuximide in various animal models of neuropathic pain, no clinical studies have been published to date on the analgesic efficacy of ethosuximide in patients with neuropathic pain. METHODS AND ANALYSIS: The Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain (EDONOT) trial is a randomised, parallel, controlled, double-blinded, multicentre clinical study. It is the first clinical trial to evaluate the efficacy and safety of ethosuximide in the treatment of non-diabetic peripheral neuropathic pain. Adult patients exhibiting peripheral neuropathic pain (Numeric Rating Scale (NRS) ≥4 and Douleur Neuropathique 4 (DN4)≥4) for at least 3 months and under stable analgesic treatment for at least 1 month will be included. Patients (n=220) will be randomly assigned to receive either ethosuximide or control treatment for 6 weeks following a 1 week run-in period. The primary end point is the intensity of neuropathic pain, assessed by NRS (0–10) before and after 6 weeks of treatment. The secondary end points are safety (adverse events are collected during the study: daily by the patient on the logbook and during planned phone calls by investigators), the intensity and features of neuropathic pain (assessed by Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI) questionnaires) and health-related quality of life (assessed by Medical Outcome Study Short Form 12 (MOS SF-12) and Leeds questionnaires). ETHICS AND COMMUNICATION: The study was approved by an independent ethics committee (CPP Sud-Est VI, France, IRB00008526) and registered by the French competent authority (Agence nationale de sécurité du médicament (ANSM)). TRIAL REGISTRATION NUMBER: NCT02100046, Recruiting.
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spelling pubmed-51686992016-12-22 Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial Kerckhove, Nicolas Mallet, Christophe Pereira, Bruno Chenaf, Chouki Duale, Christian Dubray, Claude Eschalier, Alain BMJ Open Pharmacology and Therapeutics INTRODUCTION: Currently available analgesics are ineffective in 30–50% of patients suffering from neuropathic pain and often induce deleterious side effects. T-type calcium channel blockers (mibefradil, ethosuximide, NNC 55-0396) are of great interest for the development of new symptomatic treatments of neuropathic pain, due to their various effects on pain perception. Interestingly, ethosuximide, which has already been approved for treating epilepsy, is available on the European market for clinical use. Despite numerous preclinical data demonstrating an antinociceptive effect of ethosuximide in various animal models of neuropathic pain, no clinical studies have been published to date on the analgesic efficacy of ethosuximide in patients with neuropathic pain. METHODS AND ANALYSIS: The Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain (EDONOT) trial is a randomised, parallel, controlled, double-blinded, multicentre clinical study. It is the first clinical trial to evaluate the efficacy and safety of ethosuximide in the treatment of non-diabetic peripheral neuropathic pain. Adult patients exhibiting peripheral neuropathic pain (Numeric Rating Scale (NRS) ≥4 and Douleur Neuropathique 4 (DN4)≥4) for at least 3 months and under stable analgesic treatment for at least 1 month will be included. Patients (n=220) will be randomly assigned to receive either ethosuximide or control treatment for 6 weeks following a 1 week run-in period. The primary end point is the intensity of neuropathic pain, assessed by NRS (0–10) before and after 6 weeks of treatment. The secondary end points are safety (adverse events are collected during the study: daily by the patient on the logbook and during planned phone calls by investigators), the intensity and features of neuropathic pain (assessed by Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI) questionnaires) and health-related quality of life (assessed by Medical Outcome Study Short Form 12 (MOS SF-12) and Leeds questionnaires). ETHICS AND COMMUNICATION: The study was approved by an independent ethics committee (CPP Sud-Est VI, France, IRB00008526) and registered by the French competent authority (Agence nationale de sécurité du médicament (ANSM)). TRIAL REGISTRATION NUMBER: NCT02100046, Recruiting. BMJ Publishing Group 2016-12-16 /pmc/articles/PMC5168699/ /pubmed/27986742 http://dx.doi.org/10.1136/bmjopen-2016-013530 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Pharmacology and Therapeutics
Kerckhove, Nicolas
Mallet, Christophe
Pereira, Bruno
Chenaf, Chouki
Duale, Christian
Dubray, Claude
Eschalier, Alain
Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial
title Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial
title_full Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial
title_fullStr Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial
title_full_unstemmed Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial
title_short Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial
title_sort assessment of the effectiveness and safety of ethosuximide in the treatment of non-diabetic peripheral neuropathic pain: edonot—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial
topic Pharmacology and Therapeutics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5168699/
https://www.ncbi.nlm.nih.gov/pubmed/27986742
http://dx.doi.org/10.1136/bmjopen-2016-013530
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