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

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: Ethosuximide; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Not yet recruiting
    • Uniervity hospital, Amiens
    • Principal Investigator: Sandrine SORIOT-THOMAS, MD
    • Sub-Investigator: Eric SERRAT, MD
  • Annecy, France
    • Not yet recruiting
    • Hospital of Annecy Genevois
    • Principal Investigator: Pierric Giraud, MD
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • University Hospital, Clermont Ferrand
    • Principal Investigator: Noémie Delage, MD
  • Clermont-Ferrand, France
    • Not yet recruiting
    • CIC, Hospital University, Clermont Ferrand
    • Principal Investigator: Christian DUALE, MD
  • Grenoble, France
    • Not yet recruiting
    • University Hospital, Grenoble
    • Principal Investigator: Caroline MAINDET-DOMINICI, MD
  • Limoges, France
    • Not yet recruiting
    • CHU Limoges
    • Principal Investigator: Pascale VERGNE-SALLE
  • Lyon, France
    • Not yet recruiting
    • Hospital University, Lyon
    • Principal Investigator: Christian GOV, MD
  • Saint-Étienne, France
    • Not yet recruiting
    • University Hospital, Saint Etienne
    • Principal Investigator: Christelle CREACH, MD
  • Valence, France
    • Not yet recruiting
    • Hospital of Valence
    • Principal Investigator: Todizara RANDRIAMAMONJISOA, MD
  • Voiron, France
    • Not yet recruiting
    • Hospital of Voiron
    • Principal Investigator: Gérard Mick, MD
  • Aura
    • Lyon, Aura, France, 69310
      • Not yet recruiting
      • University Hospital Lyon sud - Pierre Bénite
      • Principal Investigator: Alberta LORENZI-PERNOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ethosuximide; Patients with chronic peripheral neuropathic pain	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).
Placebo Comparator: Placebo; Patients with chronic peripheral neuropathic pain	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain intensity	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).	Day 0
Neuropathic pain intensity	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).	Day 84

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Neuropathic pain; Ethosuximide; T-type calcium channel
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Anticonvulsants; Ethosuximide
• Other Study ID Numbers: PHRC-IR 2019 DELAGE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No