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

NCT04431778 | Unknown Phase 2

• 1 other identifier: PHRC-IR 2019 DELAGE
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Peripheral Neuropathic Pain

Keywords

Ethosuximide; T-type calcium channel; Neuropathic pain

Outcome Measures

Primary Outcomes (2)

• Neuropathic pain intensity

  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).

  Day 0

• Neuropathic pain intensity

  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).

  Day 84

Secondary Outcomes (4)

• Patient's Global Impression of Change (PGIC scale)

  Day 0, Day 28, Day 56, Day 84

• Health related quality of life

  Day 0, Day 28, Day 56, Day 84

• Quantitative sensory testing (QST)

  Day 0, Day 28, Day 56, Day 84

• adverse event

  Throughout the study

Study Arms (2)

Ethosuximide

EXPERIMENTAL

Patients with chronic peripheral neuropathic pain

Drug: Ethosuximide

Placebo

PLACEBO COMPARATOR

Patients with chronic peripheral neuropathic pain

Drug: Placebo

Interventions

Ethosuximide 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).

Ethosuximide

Placebo 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (11)

University Hospital Lyon sud - Pierre Bénite

Lyon, AURA, 69310, France

NOT YET RECRUITING

Uniervity hospital, Amiens

Amiens, 80000, France

NOT YET RECRUITING

Hospital of Annecy Genevois

Annecy, France

NOT YET RECRUITING

University hospital, clermont ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CIC, Hospital University, Clermont Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

University Hospital, Grenoble

Grenoble, France

NOT YET RECRUITING

CHu Limoges

Limoges, France

NOT YET RECRUITING

Hospital University, Lyon

Lyon, France

NOT YET RECRUITING

University Hospital, Saint Etienne

Saint-Etienne, France

NOT YET RECRUITING

Hospital of Valence

Valence, France

NOT YET RECRUITING

Hospital of Voiron

Voiron, France

NOT YET RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Ethosuximide

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Succinimides; Imides; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind Placebo and ethosuximide will be indistinguishable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomisation 1:1 placebo or ethosuximide

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

FR (11)