Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain
Multicenter, randomized, double-blind, placebo-controlled therapeutic trial evaluating the efficacy and safety of low doses of ethosuximide in neuropathic pain patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
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).
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).
University Hospital Lyon sud - Pierre Bénite
Lyon, AURA, France
NOT_YET_RECRUITINGUniervity hospital, Amiens
Amiens, France
NOT_YET_RECRUITINGHospital of Annecy Genevois
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).
Time frame: 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).
Time frame: Day 84
Patient's Global Impression of Change (PGIC scale)
Assessment of the patient's feelings about the effectiveness of the treatment.
Time frame: Day 0, Day 28, Day 56, Day 84
Health related quality of life
Assessment of the patient's quality of life with EQ-5D-3L questionnaire
Time frame: Day 0, Day 28, Day 56, Day 84
Quantitative sensory testing (QST)
Assessment of mechanical sensitivity using the von Frey test (static allodynia) and the brush test (dynamic allodynia).
Time frame: Day 0, Day 28, Day 56, Day 84
adverse event
Assessment of the tolerability of the treatment by patients and clinicians
Time frame: Throughout the study
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Annecy, France
University hospital, clermont ferrand
Clermont-Ferrand, France
RECRUITINGCIC, Hospital University, Clermont Ferrand
Clermont-Ferrand, France
NOT_YET_RECRUITINGUniversity Hospital, Grenoble
Grenoble, France
NOT_YET_RECRUITINGCHu Limoges
Limoges, France
NOT_YET_RECRUITINGHospital University, Lyon
Lyon, France
NOT_YET_RECRUITINGUniversity Hospital, Saint Etienne
Saint-Etienne, France
NOT_YET_RECRUITINGHospital of Valence
Valence, France
NOT_YET_RECRUITING...and 1 more locations