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Completed

NCT Number: NCT02100046

Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.

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.

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Key information

Conditions

Neuropathic Traumatic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4 Pain Pain NRS ≥ 4 Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Neuropathic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zarontin® (ethosuximide) and Stodal®

Drug

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®

Primary outcomes

  1. 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)

Secondary outcomes

  1. Impact of ethosuximide on neuropathic pain

    Time frame: after day 43

  2. Quality of life

    Time frame: after day 43

  3. sleep and the overall impression of patients

    Time frame: after day 43

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Fondation Apicil

Registry information

Acronym: EDONOT

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 31, 2014
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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