NCT02100046

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

March 20, 2014

Last Update Submit

April 16, 2026

Conditions

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

Keywords

EthosuximideNeuropathic painPainQuality of lifeNeuropathic Pain diagnostic questionnaire ≥ 4Analgesic treatment failure for at least 3 months

Outcome Measures

Primary Outcomes (1)

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

    Δ = score NRS (Day 0) - score NRS (D +43)

    day 43

Secondary Outcomes (3)

  • Impact of ethosuximide on neuropathic pain

    after day 43

  • Quality of life

    after day 43

  • sleep and the overall impression of patients

    after day 43

Study Arms (2)

ethosuximide

EXPERIMENTAL

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®

control group

OTHER

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®

Interventions

Zarontin® (ethosuximide) and Stodal®DRUG
Also known as: 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®
control groupethosuximide

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • Patients undergoing a measure of legal protection (guardianship, supervision ...)
  • Central neuropathic pain
  • Other chronic pain (osteoarthritis, arthritis, fibromyalgia…) with intensity greater than neuropathic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

  • Kerckhove N, Pereira B, Soriot-Thomas S, Alchaar H, Deleens R, Hieng VS, Serra E, Lanteri-Minet M, Arcagni P, Picard P, Lefebvre-Kuntz D, Maindet C, Mick G, Balp L, Lucas C, Creach C, Letellier M, Martinez V, Navez M, Delbrouck D, Kuhn E, Piquet E, Bozzolo E, Brosse C, Lietar B, Marcaillou F, Hamdani A, Leroux-Bromberg N, Perier Y, Vergne-Salle P, Gov C, Delage N, Gillet D, Romettino S, Richard D, Mallet C, Bernard L, Lambert C, Dubray C, Duale C, Eschalier A. Efficacy and safety of a T-type calcium channel blocker in patients with neuropathic pain: A proof-of-concept, randomized, double-blind and controlled trial. Eur J Pain. 2018 Aug;22(7):1321-1330. doi: 10.1002/ejp.1221. Epub 2018 Apr 18.

    PMID: 29577519RESULT

  • Kerckhove N, Mallet C, Pereira B, Chenaf C, Duale C, Dubray C, Eschalier A. 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. BMJ Open. 2016 Dec 16;6(12):e013530. doi: 10.1136/bmjopen-2016-013530.

    PMID: 27986742DERIVED

MeSH Terms

Conditions

NeuralgiaPain

Interventions

Ethosuximide

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SuccinimidesImidesOrganic ChemicalsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alain ESCHALIER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 31, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2016

Study Completion

January 1, 2017

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(1)