Efficacy of Valproate in Peripheral Neuropathic Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine whether valproate is effective and well tolerated in the treatment of neuropathic peripheral pain. The drug is administered by intravenous route followed by oral route during 4 weeks.

Detailed Description
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Background. Neuropathic peripheral pain is often refractory to usual analgesics. Some anticonvulsant drugs may be effective, but often partially only, and not always well tolerated. Valproate is a well-known anticonvulsant drug, with moderate possible adverse events and for which an intravenous form is available. Aim. The principal aim is to assess the efficacy and safety of sodium Valproate in peripheral neuropathic pain. Secondary aims are to asses the effect of IV and oral treatment on neurophysiologic measures. Design. Randomized, double-blind vs. placebo, parallel groups, monocentric clinical trial. Treatments. Experimental arm: Intravenous eight-hour sodium Valproate infusion, followed by a four-week oral route sodium Valproate treatment. Control arm: Intravenous eight-hour placebo infusion, followed by a four-week oral route placebo treatment. Rescue medications are allowed in both groups. Eligibility criteria. Peripheral neuropathic pain with pain intensity of at least 40 mm on a visual analog scale. Outcomes. Primary outcome is the intensity of pain on a visual analog scale after 4 weeks of treatment. Secondary outcomes: intensity of pain after IV treatment; neurophysiologic measures (thermal thresholds, RIII reflex); association of response to IV treatment with oral treatment efficacy.

Official Title
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Efficacy of a Therapeutic Strategy in Peripheral Neuropathic Pain: Intravenous Sodium Valproate Followed by Oral Route Treatment Versus Placebo (Clinical and Neurophysiologic Evaluation)

Conditions
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Neuralgia, Neuropathic Peripheral Pain

Intervention / Treatment
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* Drug: Sodium Valproate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: peripheral neuropathic pain signed written informed consent Exclusion Criteria: central neuropathic pain current or past hepatic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sodium Valproate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain on a visual analog scale |  | after 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of mechanic allodynia |  |  | 
| intensity of dynamic allodynia |  |  | 
| use of analgesics (rescue medication) |  |  | 
| thermal sensitive and nociceptive thresholds, RIII reflex |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuralgia, Valproate, Anticonvulsant Drugs, Pain Measurement, Randomized Controlled Trials