Clinical trial NCT04431778: Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
Official title: Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Neuropathic Pain
Keywords: Ethosuximide
T-type calcium channel
Neuropathic pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomisation 1:1 placebo or ethosuximide
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Neuropathic pain intensity
timeFrame: Day 0
measure: Neuropathic pain intensity
timeFrame: Day 84
Secondary outcomes:
measure: Patient's Global Impression of Change (PGIC scale)
timeFrame: Day 0, Day 28, Day 56, Day 84
measure: Health related quality of life
timeFrame: Day 0, Day 28, Day 56, Day 84
measure: Quantitative sensory testing (QST)
timeFrame: Day 0, Day 28, Day 56, Day 84
measure: adverse event
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Lyon
country: France
facility: University Hospital Lyon sud - Pierre Bénite
state: Aura
city: Amiens
country: France
facility: Uniervity hospital, Amiens
city: Annecy
country: France
facility: Hospital of Annecy Genevois
city: Clermont-Ferrand
country: France
facility: University hospital, clermont ferrand
city: Clermont-Ferrand
country: France
facility: CIC, Hospital University, Clermont Ferrand
city: Grenoble
country: France
facility: University Hospital, Grenoble
city: Limoges
country: France
facility: CHu Limoges
city: Lyon
country: France
facility: Hospital University, Lyon
city: Saint-Étienne
country: France
facility: University Hospital, Saint Etienne
city: Valence
country: France
facility: Hospital of Valence
city: Voiron
country: France
facility: Hospital of Voiron
Study officials:
References: