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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004801-26 |
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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
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: ZarontinĀ®.
The purpose of this study is to assess the effectiveness of ethosuximide (ZarontinĀ®) on the pain symptoms and quality of life in patients with peripheral neuropathic pain compared to a control group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ethosuximide | Experimental | The purpose of this study is to assess the effectiveness of ethosuximide (ZarontinĀ®) on the pain symptoms and quality of life in patients with neuropathic traumatic pain compared to a control group. |
|
| control group | Other | The purpose of this study is to assess the effectiveness of ethosuximide (ZarontinĀ®) on the pain symptoms and quality of life in patients with neuropathic traumatic pain compared to a control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZarontinĀ® (ethosuximide) and StodalĀ® | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients | Ī = score NRS (Day 0) - score NRS (D +43) | day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of ethosuximide on neuropathic pain | after day 43 | |
| Quality of life | after day 43 | |
| sleep and the overall impression of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain ESCHALIER | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29577519 | Result | 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. | |
| 27986742 |
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| after day 43 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005013 | Ethosuximide |
| ID | Term |
|---|---|
| D013388 | Succinimides |
| D007094 | Imides |
| D009930 | Organic Chemicals |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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