NCT00221637

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

September 13, 2005

Last Update Submit

June 12, 2007

Conditions

NeuralgiaNeuropathic Peripheral Pain

Keywords

NeuralgiaValproateAnticonvulsant DrugsPain MeasurementRandomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain on a visual analog scale

    after 4 weeks of treatment

Secondary Outcomes (4)

  • intensity of mechanic allodynia

  • intensity of dynamic allodynia

  • use of analgesics (rescue medication)

  • thermal sensitive and nociceptive thresholds, RIII reflex

Interventions

Sodium ValproateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • peripheral neuropathic pain
  • signed written informed consent

You may not qualify if:

  • central neuropathic pain
  • current or past hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Virginie Dousset, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Paul Perez, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

March 1, 2002

Study Completion

July 1, 2005

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations

FR(1)