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Efficacy of Valproate in Peripheral Neuropathic Pain

NCT ID: NCT00221637

Last Updated: 2007-06-13

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

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-07-31

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.

Conditions

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Neuralgia Neuropathic Peripheral Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sodium Valproate

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi-Synthelabo

INDUSTRY

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Principal Investigators

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Virginie Dousset, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Paul Perez, Dr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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Unité de traitement de la douleur chronique, Hôpital Pellegrin, CHU de Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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2000-003

Identifier Type: -

Identifier Source: secondary_id

9236-01

Identifier Type: -

Identifier Source: org_study_id