Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain (E-PENEPA)

University Hospital, Clermont-Ferrand

Status and phase: Enrolling; Phase 2

Conditions: Peripheral Neuropathic Pain

Treatments: Drug: Ethosuximide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04431778

PHRC-IR 2019 DELAGE

Details and patient eligibility

About

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

Full description

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Ethosuximide

Experimental group

Description:

Patients with chronic peripheral neuropathic pain

Treatment:

Drug: Ethosuximide

Placebo

Placebo Comparator group

Description:

Patients with chronic peripheral neuropathic pain

Treatment:

Drug: Placebo