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

NCT02100046 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Neuropathic Traumatic Pain
  • Pain NRS ≥ 4
  • Peripheral Neuropathic Pain
  • Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4

Interventions

DRUG

Zarontin® (ethosuximide) and Stodal®

Sponsors & Collaborators

  • Fondation Apicil

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Alain ESCHALIER · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-09-30
Completion
2017-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02100046 on ClinicalTrials.gov