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

Peripheral Neuropathic Pain Clinical Trial

— E-PENEPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04431778
• Other study ID #: PHRC-IR 2019 DELAGE
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ßHCG+ 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).

Related Conditions & MeSH terms

• Neuralgia
• Peripheral Neuropathic Pain

Intervention

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
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).

Locations

Country	Name	City	State
France	Uniervity hospital, Amiens	Amiens
France	Hospital of Annecy Genevois	Annecy
France	CIC, Hospital University, Clermont Ferrand	Clermont-Ferrand
France	University hospital, clermont ferrand	Clermont-Ferrand
France	University Hospital, Grenoble	Grenoble
France	CHu Limoges	Limoges
France	Hospital University, Lyon	Lyon
France	University Hospital Lyon sud - Pierre Bénite	Lyon	Aura
France	University Hospital, Saint Etienne	Saint-Étienne
France	Hospital of Valence	Valence
France	Hospital of Voiron	Voiron

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	adverse event	Assessment of the tolerability of the treatment by patients and clinicians	Throughout the study