Peripheral Neuropathic PainPhase 2E-PENEPANCT04431778
Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
A Phase 2 study testing Ethosuximide in people with Peripheral Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 11 sites in France.
Trial summary
Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathic Pain
- What is being tested?
- Ethosuximide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Nov 2020to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
Uniervity hospital, Amiens
Amiens, 80000
Sandrine SORIOT-THOMAS, MD
Eric SERRAT, MD
- Not yet recruiting
Hospital of Annecy Genevois
Annecy
Pierric Giraud, MD
- Recruiting
University hospital, clermont ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Noémie Delage, MD
- Not yet recruiting
CIC, Hospital University, Clermont Ferrand
Clermont-Ferrand
Christian DUALE, MD
- Not yet recruiting
University Hospital, Grenoble
Grenoble
Caroline MAINDET-DOMINICI, MD
- Not yet recruiting
CHu Limoges
Limoges
Pascale VERGNE-SALLE
- Not yet recruiting
University Hospital Lyon sud - Pierre Bénite
Lyon, AURA, 69310
Alberta LORENZI-PERNOT
- Not yet recruiting
Hospital University, Lyon
Lyon
Christian GOV, MD
- Not yet recruiting
University Hospital, Saint Etienne
Saint-Etienne
Christelle CREACH, MD
- Not yet recruiting
Hospital of Valence
Valence
Todizara RANDRIAMAMONJISOA, MD
- Not yet recruiting
Hospital of Voiron
Voiron
Gérard Mick, MD
About this study
Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain
Read the detailed description
Multicenter, randomized, double-blind, placebo-controlled therapeutic trial evaluating the efficacy and safety of low doses of ethosuximide in neuropathic pain patients.
- Conditions
- Peripheral Neuropathic Pain
- Being tested
- Ethosuximide, Placebo
- Keywords
- Ethosuximide, T-type calcium channel, Neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthosuximideDrug
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).
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Ethosuximide | Experimental | Patients with chronic peripheral neuropathic pain Receives: Drug: Ethosuximide |
| Placebo | Placebo comparator | Patients with chronic peripheral neuropathic pain Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 84
Secondary outcomes (4)
Patient's Global Impression of Change (PGIC scale)
Assessment of the patient's feelings about the effectiveness of the treatment.
Measured: 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
Measured: 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).
Measured: Day 0, Day 28, Day 56, Day 84
adverse event
Assessment of the tolerability of the treatment by patients and clinicians
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Nov 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation 1:1 placebo or ethosuximide
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431778
- Sponsor's protocol ID
- PHRC-IR 2019 DELAGE
- Acronym
- E-PENEPA
- Status last verified
- Jan 2023
- First submitted
- 10 Jun 2020
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04431778
- Acronym / sponsor ID
- E-PENEPA / PHRC-IR 2019 DELAGE
- Conditions
- Peripheral Neuropathic Pain
- Keywords
- Ethosuximide, T-type calcium channel, Neuropathic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomisation 1:1 placebo or ethosuximide
| Arm | Type | Receives |
|---|---|---|
| Ethosuximide | Experimental | Drug: EthosuximidePatients with chronic peripheral neuropathic pain |
| Placebo | Placebo comparator | Drug: PlaceboPatients with chronic peripheral neuropathic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthosuximideTaking 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 | Ethosuximide |
| PlaceboTaking 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 |
Primary outcome
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).
4 secondary outcomes
Patient's Global Impression of Change (PGIC scale)
Time frame: Day 0, Day 28, Day 56, Day 84
Health related quality of life
Time frame: Day 0, Day 28, Day 56, Day 84
Quantitative sensory testing (QST)
Time frame: Day 0, Day 28, Day 56, Day 84
adverse event
Time frame: Throughout the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ethosuximide in people with Peripheral Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain intensity (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.