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

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ClinicalTrials.gov Identifier: NCT02100046
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Neuropathic Traumatic Pain Pain NRS ≥ 4 Peripheral Neuropathic Pain Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4 Drug: Zarontin® (ethosuximide) and Stodal® Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
Actual Study Start Date : March 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ethosuximide
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®
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®

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.
Drug: Zarontin® (ethosuximide) and Stodal®
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100046


Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fondation Apicil
Investigators
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Principal Investigator: Alain ESCHALIER University Hospital, Clermont-Ferrand

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02100046     History of Changes
Other Study ID Numbers: CHU-0186
2013-004801-26
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Keywords provided by University Hospital, Clermont-Ferrand:
Ethosuximide
Neuropathic pain
Pain
Quality of life
Neuropathic Pain diagnostic questionnaire ≥ 4
Analgesic treatment failure for at least 3 months
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ethosuximide
Anticonvulsants