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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-01-01

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Zarontin® (ethosuximide) and Stodal®

Intervention Type DRUG

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.

Group Type OTHER

Zarontin® (ethosuximide) and Stodal®

Intervention Type DRUG

Interventions

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Zarontin® (ethosuximide) and Stodal®

Intervention Type DRUG

Other Intervention Names

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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®

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No