Status:
UNKNOWN
Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Peripheral Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04431778
Start Date
November 1 2020
End Date
December 31 2023
Last Update
January 6 2023
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Lyon sud - Pierre Bénite
Lyon, AURA, France, 69310
2
Uniervity hospital, Amiens
Amiens, France, 80000
3
Hospital of Annecy Genevois
Annecy, France
4
University hospital, clermont ferrand
Clermont-Ferrand, France, 63000