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

Peripheral Neuropathic Pain Clinical Trial

— EDONOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100046
• Other study ID #: CHU-0186
• Secondary ID: 2013-004801-26
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2014
• Last updated: April 3, 2018
• Start date: March 2014
• Est. completion date: January 1, 2017

Study information

• Verified date: April 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 1, 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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%, ß-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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain Diagnostic Questionnaire (DN4) = 4
• Neuropathic Traumatic Pain
• Pain NRS = 4
• Peripheral Neuropathic Pain

Intervention

Drug:
• Zarontin® (ethosuximide) and Stodal®

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Fondation Apicil

Country where clinical trial is conducted

France, 

References & Publications (1)

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, randomised, double-blind and controlled trial. Eur J Pain. 2018 Mar 25. doi: 10.1002/ejp.1221. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients	? = score NRS (Day 0) - score NRS (D +43)	day 43
Secondary	Impact of ethosuximide on neuropathic pain		after day 43
Secondary	Quality of life		after day 43
Secondary	sleep and the overall impression of patients		after day 43

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