Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain

  • STATUS
    Recruiting
  • End date
    Dec 12, 2022
  • participants needed
    64
  • sponsor
    University Hospital, Clermont-Ferrand
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Updated on 21 November 2020
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Investigator
Lise Laclautre
Primary Contact
Hospital of Valence (0.0 mi away) Contact
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Summary

Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain

Description

Multicenter, randomized, double-blind, placebo-controlled therapeutic trial evaluating the efficacy and safety of low doses of ethosuximide in neuropathic pain patients.

Details
Treatment Placebo, Ethosuximide
Clinical Study IdentifierNCT04431778
SponsorUniversity Hospital, Clermont-Ferrand
Last Modified on21 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Peripheral Neuropathic Pain??
Male or female (under effective contraception: pill, implant, IUD, sterilization) aged 18 years or older, suffering from peripheral neuropathic pain (DN4 4) for more than 3 months and less than 5 years, of intensity 4 on a numerical scale from 0 to 10, and whose analgesic treatment has been stable for more than a month
Patients affiliated to the French Social Security system
Patients whose free and informed consent has been obtained

Exclusion Criteria

Pregnancy (HCG+ blood) or breastfeeding
Neuropathic pain due to spinal cord or brain injury, phantom limb pain or algohallucinosis
Fibromyalgia or algodystrophy
Chronic pain syndrome that the patient cannot distinguish and/or is more intense than peripheral neuropathic pain
Patient on antiepileptic drugs (to limit the possible potentiation of adverse reactions from ethosuximide). If necessary, after agreement with the patient, a 14-day washout prior to the start of the study will be authorized for inclusion
Significant abnormalities in liver (transaminases > 3N, cholestasis) and renal (MDRD < 60 mL/min) tests
Ongoing comorbidities: cancer, neurodegenerative pathology
Severe depressive disorder in progress (as determined by the clinician), history of suicide attempts or hospitalization for depression
Diabetic patients (contraindicated due to the high sugar concentration of ethosuximide, 3g / 5 ml)
Patients who have previously received ethosuximide (epilepsy or clinical trial)
Surgery planned throughout the entire trial
Medical and surgical history incompatible with the study
Dependence on alcohol and/or drugs (for compliance purposes)
Known allergy to succinimides (ethosuximide, methsuximide, phensuximide)
Psychotic disorders
Epileptic patients
Patients benefiting from a legal protection measure (curatorship, guardianship, deprived of liberty or subject to judicial safeguard)
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