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

January 5, 2023 updated by: University Hospital, Clermont-Ferrand
Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day 0
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).
Day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 0, Day 28, Day 56, Day 84
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
Day 0, Day 28, Day 56, Day 84
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).
Day 0, Day 28, Day 56, Day 84
adverse event
Time Frame: Throughout the study
Assessment of the tolerability of the treatment by patients and clinicians
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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