Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4, Neuropathic Traumatic Pain, Pain NRS ≥ 4, Peripheral Neuropathic Pain
Conditions
Keywords
Ethosuximide, Neuropathic pain, Pain, Quality of life, Neuropathic Pain diagnostic questionnaire ≥ 4, Analgesic treatment failure for at least 3 months
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.
Interventions
DRUGZarontin® (ethosuximide) and Stodal®
Sponsors
University Hospital, Clermont-Ferrand
Fondation Apicil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients | day 43 | Δ = score NRS (Day 0) - score NRS (D +43) |
Secondary
| Measure | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAlain ESCHALIER
University Hospital, Clermont-Ferrand
Outcome results
None listed