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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Zarontin® (ethosuximide) and Stodal®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ethosuximide<br>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®<br> <br> * Other names: Inactive substance: Stodal® administration: oral syrup using a graduated pipette. Duration of treatment: 42 days. Same dosage as Zarontin®;|
| Other: control group<br>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®<br> <br> * Other names: Inactive substance: Stodal® administration: oral syrup using a graduated pipette. Duration of treatment: 42 days. Same dosage as Zarontin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients | Δ = score NRS (Day 0) - score NRS (D +43) | day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ethosuximide, Neuropathic pain, Pain, Quality of life, Neuropathic Pain diagnostic questionnaire ≥ 4, Analgesic treatment failure for at least 3 months