Efficacy of Valproate in Peripheral Neuropathic Pain

This study has been terminated.
(slow recruitment and treatments beyond expiry date)
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221637
First received: September 13, 2005
Last updated: June 12, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Neuralgia
Neuropathic Peripheral Pain
Drug: Sodium Valproate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Intensity of pain on a visual analog scale [ Time Frame: after 4 weeks of treatment ]

Secondary Outcome Measures:
  • intensity of mechanic allodynia
  • intensity of dynamic allodynia
  • use of analgesics (rescue medication)
  • thermal sensitive and nociceptive thresholds, RIII reflex

Enrollment: 40
Study Start Date: March 2002
Study Completion Date: July 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • peripheral neuropathic pain
  • signed written informed consent

Exclusion Criteria:

  • central neuropathic pain
  • current or past hepatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221637

Locations
France
Unité de traitement de la douleur chronique, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Sanofi-Synthelabo
Investigators
Principal Investigator: Virginie Dousset, Dr University Hospital, Bordeaux
Study Chair: Paul Perez, Dr University Hospital, Bordeaux
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221637     History of Changes
Other Study ID Numbers: 9236-01, 2000-003
Study First Received: September 13, 2005
Last Updated: June 12, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Neuralgia
Valproate
Anticonvulsant Drugs
Pain Measurement
Randomized Controlled Trials

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Anticonvulsants
Valproic Acid
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 28, 2014