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

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

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

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

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,
• 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).