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

Primary Purpose

Peripheral Neuropathic Pain

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ethosuximide
Placebo
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathic Pain focused on measuring Ethosuximide, T-type calcium channel, Neuropathic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • University Hospital Lyon sud - Pierre Bénite
  • Uniervity hospital, Amiens
  • Hospital of Annecy Genevois
  • University hospital, clermont ferrandRecruiting
  • CIC, Hospital University, Clermont Ferrand
  • University Hospital, Grenoble
  • CHu Limoges
  • Hospital University, Lyon
  • University Hospital, Saint Etienne
  • Hospital of Valence
  • Hospital of Voiron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ethosuximide

Placebo

Arm Description

Patients with chronic peripheral neuropathic pain

Patients with chronic peripheral neuropathic pain

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2020
Last Updated
January 5, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04431778
Brief Title
Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
Acronym
E-PENEPA
Official Title
Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain
Detailed Description
Multicenter, randomized, double-blind, placebo-controlled therapeutic trial evaluating the efficacy and safety of low doses of ethosuximide in neuropathic pain patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathic Pain
Keywords
Ethosuximide, T-type calcium channel, Neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomisation 1:1 placebo or ethosuximide
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind Placebo and ethosuximide will be indistinguishable.
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ethosuximide
Arm Type
Experimental
Arm Description
Patients with chronic peripheral neuropathic pain
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients with chronic peripheral neuropathic pain
Intervention Type
Drug
Intervention Name(s)
Ethosuximide
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Neuropathic pain intensity
Description
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).
Time Frame
Day 0
Title
Neuropathic pain intensity
Description
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).
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
Patient's Global Impression of Change (PGIC scale)
Description
Assessment of the patient's feelings about the effectiveness of the treatment.
Time Frame
Day 0, Day 28, Day 56, Day 84
Title
Health related quality of life
Description
Assessment of the patient's quality of life with EQ-5D-3L questionnaire
Time Frame
Day 0, Day 28, Day 56, Day 84
Title
Quantitative sensory testing (QST)
Description
Assessment of mechanical sensitivity using the von Frey test (static allodynia) and the brush test (dynamic allodynia).
Time Frame
Day 0, Day 28, Day 56, Day 84
Title
adverse event
Description
Assessment of the tolerability of the treatment by patients and clinicians
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Information:
Facility Name
University Hospital Lyon sud - Pierre Bénite
City
Lyon
State/Province
Aura
ZIP/Postal Code
69310
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberta LORENZI-PERNOT
Facility Name
Uniervity hospital, Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine SORIOT-THOMAS, MD
First Name & Middle Initial & Last Name & Degree
Eric SERRAT, MD
Facility Name
Hospital of Annecy Genevois
City
Annecy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierric Giraud, MD
Facility Name
University hospital, clermont ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Noémie Delage, MD
Facility Name
CIC, Hospital University, Clermont Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian DUALE, MD
Facility Name
University Hospital, Grenoble
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline MAINDET-DOMINICI, MD
Facility Name
CHu Limoges
City
Limoges
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale VERGNE-SALLE
Facility Name
Hospital University, Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian GOV, MD
Facility Name
University Hospital, Saint Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle CREACH, MD
Facility Name
Hospital of Valence
City
Valence
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todizara RANDRIAMAMONJISOA, MD
Facility Name
Hospital of Voiron
City
Voiron
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérard Mick, MD

12. IPD Sharing Statement

Learn more about this trial

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

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