Clinical trial NCT00221637: Efficacy of Valproate in Peripheral Neuropathic Pain
Official title: Efficacy of a Therapeutic Strategy in Peripheral Neuropathic Pain: Intravenous Sodium Valproate Followed by Oral Route Treatment Versus Placebo (Clinical and Neurophysiologic Evaluation)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Neuralgia
Neuropathic Peripheral Pain
Keywords: Neuralgia
Valproate
Anticonvulsant Drugs
Pain Measurement
Randomized Controlled Trials
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* peripheral neuropathic pain
* signed written informed consent

Exclusion Criteria:

* central neuropathic pain
* current or past hepatic disease

Primary outcomes:
measure: Intensity of pain on a visual analog scale
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: intensity of mechanic allodynia
measure: intensity of dynamic allodynia
measure: use of analgesics (rescue medication)
measure: thermal sensitive and nociceptive thresholds, RIII reflex
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Unité de traitement de la douleur chronique, Hôpital Pellegrin, CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Virginie Dousset, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Paul Perez, Dr
role: STUDY_CHAIR
References: