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

• Status: Recruiting
• Trial end date: 2022-12-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Ethosuximide

Criteria

Inclusion Criteria:

• 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, 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 (βHCG+ 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).