Trials / Completed
CompletedNCT02100046
Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- University Hospital, Clermont-Ferrand · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Neuropathic Traumatic Pain
- Pain NRS ≥ 4
- Peripheral Neuropathic Pain
- Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zarontin® (ethosuximide) and Stodal® |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2016-09-01
- Completion
- 2017-01-01
- First posted
- 2014-03-31
- Last updated
- 2018-04-04
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02100046. Inclusion in this directory is not an endorsement.