Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
- Registration Number
- NCT04431778
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients with chronic peripheral neuropathic pain Ethosuximide Ethosuximide Patients with chronic peripheral neuropathic pain
- Primary Outcome Measures
Name Time Method Neuropathic pain intensity 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).
- Secondary Outcome Measures
Name Time Method Patient's Global Impression of Change (PGIC scale) Day 0, Day 28, Day 56, Day 84 Assessment of the patient's feelings about the effectiveness of the treatment.
Health related quality of life Day 0, Day 28, Day 56, Day 84 Assessment of the patient's quality of life with EQ-5D-3L questionnaire
Quantitative sensory testing (QST) 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).
adverse event Throughout the study Assessment of the tolerability of the treatment by patients and clinicians
Trial Locations
- Locations (11)
Hospital of Annecy Genevois
🇫🇷Annecy, France
Hospital University, Lyon
🇫🇷Lyon, France
CHu Limoges
🇫🇷Limoges, France
University Hospital, Grenoble
🇫🇷Grenoble, France
University hospital, clermont ferrand
🇫🇷Clermont-Ferrand, France
Hospital of Valence
🇫🇷Valence, France
University Hospital, Saint Etienne
🇫🇷Saint-Étienne, France
Hospital of Voiron
🇫🇷Voiron, France
Uniervity hospital, Amiens
🇫🇷Amiens, France
CIC, Hospital University, Clermont Ferrand
🇫🇷Clermont-Ferrand, France
University Hospital Lyon sud - Pierre Bénite
🇫🇷Lyon, Aura, France