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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2023

Detailed Description

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

Interventions

  • Drug: Ethosuximide
    • Taking the treatment (1 daily intake during the evening meal) according to increasing dosage: Step 1: 2.5 ml (125 mg) / day for 7 days Step 2: 5 ml (250 mg) / day for 7 days Step 3: 7.5 ml (375 mg) / day for 7 days Step 4 (final): 10 ml (500 mg) / day for the remainder of the study (12 weeks).
  • Drug: Placebo
    • Taking the treatment (1 daily intake during the evening meal) according to increasing dosage: Step 1: 2.5 ml (125 mg) / day for 7 days Step 2: 5 ml (250 mg) / day for 7 days Step 3: 7.5 ml (375 mg) / day for 7 days Step 4 (final): 10 ml (500 mg) / day for the remainder of the study (12 weeks).

Arms, Groups and Cohorts

  • Experimental: Ethosuximide
    • Patients with chronic peripheral neuropathic pain
  • Placebo Comparator: Placebo
    • Patients with chronic peripheral neuropathic pain

Clinical Trial Outcome Measures

Primary Measures

  • Neuropathic pain intensity
    • Time Frame: Day 0
    • Variation in pain intensity (NRS, Numerical Rating Scale 0-10) averaged over the 7 days prior to the start of treatment (D0) and over the last 7 days of treatment (12 weeks).
  • Neuropathic pain intensity
    • Time Frame: Day 84
    • Variation in pain intensity (NRS, Numerical Rating Scale 0-10) averaged over the 7 days prior to the start of treatment (D0) and over the last 7 days of treatment (12 weeks).

Secondary Measures

  • Patient’s Global Impression of Change (PGIC scale)
    • Time Frame: Day 0, Day 28, Day 56, Day 84
    • Assessment of the patient’s feelings about the effectiveness of the treatment.
  • Health related quality of life
    • Time Frame: Day 0, Day 28, Day 56, Day 84
    • Assessment of the patient’s quality of life with EQ-5D-3L questionnaire
  • Quantitative sensory testing (QST)
    • Time Frame: Day 0, Day 28, Day 56, Day 84
    • Assessment of mechanical sensitivity using the von Frey test (static allodynia) and the brush test (dynamic allodynia).
  • adverse event
    • Time Frame: Throughout the study
    • Assessment of the tolerability of the treatment by patients and clinicians

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr

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