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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-12-31

Brief Summary

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

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Detailed Description

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

Conditions

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Peripheral Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomisation 1:1 placebo or ethosuximide

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind Placebo and ethosuximide will be indistinguishable.

Study Groups

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Ethosuximide

Patients with chronic peripheral neuropathic pain

Group Type EXPERIMENTAL

Ethosuximide

Intervention Type DRUG

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

Patients with chronic peripheral neuropathic pain

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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