CompletedPhase 2

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

France114 participantsStarted 2014-03

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients

Timeframe: day 43

Trial details

NCT IDNCT02100046

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Neuropathic Traumatic Pain trials