Neuropathic Traumatic PainPhase 2EDONOTNCT02100046
Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
A Phase 2 study testing Zarontin® (ethosuximide) and Stodal® in people with Neuropathic Traumatic Pain and Pain NRS ≥ 4, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Neuropathic Traumatic Pain, Pain NRS ≥ 4, Peripheral Neuropathic Pain
- What is being tested?
- Zarontin® (ethosuximide) and Stodal®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to 1 Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neuropathic Traumatic Pain, Pain NRS ≥ 4, Peripheral Neuropathic Pain, Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4
- Being tested
- Zarontin® (ethosuximide) and Stodal®
- Keywords
- Ethosuximide, Neuropathic pain, Pain, Quality of life, Neuropathic Pain diagnostic questionnaire ≥ 4, Analgesic treatment failure for at least 3 months
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zarontin® (ethosuximide) and Stodal®Drug
Also called 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®
| Study group | Role | What they receive |
|---|---|---|
| ethosuximide | Experimental | 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. Receives: Drug: Zarontin® (ethosuximide) and Stodal® |
| control group | Other | 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. Receives: Drug: Zarontin® (ethosuximide) and Stodal® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients
Δ = score NRS (Day 0) - score NRS (D +43)
Measured: day 43
Secondary outcomes (3)
Impact of ethosuximide on neuropathic pain
Measured: after day 43
Quality of life
Measured: after day 43
sleep and the overall impression of patients
Measured: after day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic Traumatic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Alain ESCHALIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100046
- Sponsor's protocol ID
- CHU-0186
- Other IDs
- 2013-004801-26
- Acronym
- EDONOT
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
Publications
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.
PubMed 29577519Kerckhove 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.
PubMed 27986742
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
- ClinicalTrials.gov ID
- NCT02100046
- Acronym / sponsor ID
- EDONOT / CHU-0186
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- Mar 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ethosuximide | Experimental | Drug: Zarontin® (ethosuximide) and Stodal®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. |
| control group | Other | Drug: Zarontin® (ethosuximide) and Stodal®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zarontin® (ethosuximide) and Stodal®Also: 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® | Drug | control group, ethosuximide |
Primary outcome
Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients
Time frame: day 43
Δ = score NRS (Day 0) - score NRS (D +43)
3 secondary outcomes
Impact of ethosuximide on neuropathic pain
Time frame: after day 43
Quality of life
Time frame: after day 43
sleep and the overall impression of patients
Time frame: after day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 29577519Kerckhove 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.
- Derived from this study: PubMed 27986742Kerckhove 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain ESCHALIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zarontin® (ethosuximide) and Stodal® in people with Neuropathic Traumatic Pain and Pain NRS ≥ 4, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients (time frame: day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100046, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.