Clinical trial NCT02100046: Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
Official title: Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2014-03-31
Enrollment: 114
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients
timeFrame: day 43
Secondary outcomes:
measure: Impact of ethosuximide on neuropathic pain
timeFrame: after day 43
measure: Quality of life
timeFrame: after day 43
measure: sleep and the overall impression of patients
timeFrame: after day 43
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Alain ESCHALIER
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.