Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain. (EDONOT)

April 3, 2018 updated by: University Hospital, Clermont-Ferrand

Currently, it is established that the voltage-gated calcium channels modulate pain perception due to an influence on the neuronal transmission and excitability. In the past, attention has focused on the modulation of high voltage activated calcium channel. More recently, scientific interest has proven to the low voltage activated calcium channel, also called T-type channels. The data from the literature show significant involvement of these channels in the physiology of nociception and pathophysiology of acute and chronic pain. Moreover, in several animal pain models (acute, neuropathic, inflammatory), T-type channels inhibition alleviates painful behaviours.

Analgesics treatments available in clinic are ineffective in some patients with chronic pain (neuropathic, inflammatory) and often induce deleterious side effects. Thus, the clinical use of selective inhibitors of T-type channels could not only help the development of new therapies for the treatment of neuropathic pain (prevalence = 5-8 %), but also have a pharmaco-economic impact due to the low selling price of their inhibitor currently available: Zarontin®.

The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the pain symptoms and quality of life in patients with peripheral neuropathic pain compared to a control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicentre, parallel-group, double-blind, randomised clinical trial comparing ethosuximide and inactive control for the treatment of peripheral neuropathic pain, assessed by numerical rating scale and quality of life questionnaire.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Traumatic neuropathy or post-surgical (excluding amputations) with Neuropathic -Pain Diagnostic DN4 ≥ 4 positive and IASP criteria
  • ENS pain ≥ 4
  • ALT, AST, PAL, normal GGT, creatinine <133μmol / L, hematocrit> 38%, β-HCG
  • Patients affiliated to the French Social Security
  • Patients with free and informed consent has been obtained
  • Peripheral neuropathic pain with Neuropathic Pain Diagnostic DN4 ≥ 4 positive

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Diabetic neuropathy, post-herpetic neuralgia, cancer or chemotherapy-induced,
  • Patients with impaired glucose tolerance,
  • Medical and surgical history incompatible with the study,
  • History of renal disease and / or liver,
  • Addiction to alcohol and / or drugs,
  • Taking antiepileptic family carboxamides and ethosuximide
  • Use of St. John's wort,
  • Allergy succinimides (ethosuximide, methsuximide, phensuximide)
  • Psychotic disorders,
  • Patients with epilepsy,
  • Patient exclusion period, or the total allowable compensation exceeded
  • Patients undergoing a measure of legal protection (guardianship, supervision ...)
  • Central neuropathic pain
  • Other chronic pain (osteoarthritis, arthritis, fibromyalgia…) with intensity greater than neuropathic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ethosuximide
The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the pain symptoms and quality of life in patients with neuropathic traumatic pain compared to a control group.
Drug: Zarontin® (ethosuximide) and Stodal®
Other Names:
  • Zarontin® (ethosuximide), administration: oral syrup using a graduated pipette. Duration of treatment: 42 days
  • Inactive substance: Stodal® administration: oral syrup using a graduated pipette. Duration of treatment: 42 days. Same dosage as Zarontin®
Other: control group
The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the pain symptoms and quality of life in patients with neuropathic traumatic pain compared to a control group.
Drug: Zarontin® (ethosuximide) and Stodal®
Other Names:
  • Zarontin® (ethosuximide), administration: oral syrup using a graduated pipette. Duration of treatment: 42 days
  • Inactive substance: Stodal® administration: oral syrup using a graduated pipette. Duration of treatment: 42 days. Same dosage as Zarontin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients
Time Frame: day 43
Δ = score NRS (Day 0) - score NRS (D +43)
day 43

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of ethosuximide on neuropathic pain
Time Frame: after day 43
after day 43
Quality of life
Time Frame: after day 43
after day 43
sleep and the overall impression of patients
Time Frame: after day 43
after day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Fondation Apicil

Investigators

  • Principal Investigator: Alain ESCHALIER, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0186
  • 2013-004801-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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