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

Primary Purpose

Neuropathic Traumatic Pain, Pain NRS ≥ 4, Peripheral Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Zarontin® (ethosuximide) and Stodal®
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Traumatic Pain focused on measuring Ethosuximide, Neuropathic pain, Pain, Quality of life, Neuropathic Pain diagnostic questionnaire ≥ 4, Analgesic treatment failure for at least 3 months

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ethosuximide

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients
Δ = score NRS (Day 0) - score NRS (D +43)

Secondary Outcome Measures

Impact of ethosuximide on neuropathic pain
Quality of life
sleep and the overall impression of patients

Full Information

First Posted
March 20, 2014
Last Updated
April 3, 2018
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation Apicil
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1. Study Identification

Unique Protocol Identification Number
NCT02100046
Brief Title
Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
Acronym
EDONOT
Official Title
Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation Apicil

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Traumatic Pain, Pain NRS ≥ 4, Peripheral Neuropathic Pain, Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4
Keywords
Ethosuximide, Neuropathic pain, Pain, Quality of life, Neuropathic Pain diagnostic questionnaire ≥ 4, Analgesic treatment failure for at least 3 months

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ethosuximide
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zarontin® (ethosuximide) and Stodal®
Other Intervention Name(s)
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 Outcome Measure Information:
Title
Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients
Description
Δ = score NRS (Day 0) - score NRS (D +43)
Time Frame
day 43
Secondary Outcome Measure Information:
Title
Impact of ethosuximide on neuropathic pain
Time Frame
after day 43
Title
Quality of life
Time Frame
after day 43
Title
sleep and the overall impression of patients
Time Frame
after day 43

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain ESCHALIER
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29577519
Citation
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.
Results Reference
background
PubMed Identifier
27986742
Citation
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.
Results Reference
derived

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

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