Peripheral Neuropathic Pain
Conditions
Keywords
Ethosuximide, T-type calcium channel, Neuropathic pain
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.
Interventions
DRUGEthosuximide
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).
DRUGPlacebo
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).
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind Placebo and ethosuximide will be indistinguishable.
Intervention model description
Randomisation 1:1 placebo or ethosuximide
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic pain intensity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed