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Efficacy of Valproate in Peripheral Neuropathic Pain

This study has been terminated.
(slow recruitment and treatments beyond expiry date)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221637
First Posted: September 22, 2005
Last Update Posted: June 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi-Synthelabo
Information provided by:
University Hospital, Bordeaux
September 13, 2005
September 22, 2005
June 13, 2007
March 2002
Not Provided
Intensity of pain on a visual analog scale [ Time Frame: after 4 weeks of treatment ]
Intensity of pain on a visual analog scale after 4 weeks of treatment
Complete list of historical versions of study NCT00221637 on ClinicalTrials.gov Archive Site
  • intensity of mechanic allodynia
  • intensity of dynamic allodynia
  • use of analgesics (rescue medication)
  • thermal sensitive and nociceptive thresholds, RIII reflex
  • - intensity of mechanic allodynia
  • - intensity of dynamic allodynia
  • - use of analgesics (rescue medication)
  • - thermal sensitive and nociceptive thresholds, RIII reflex
Not Provided
Not Provided
 
Efficacy of Valproate in Peripheral Neuropathic Pain
Efficacy of a Therapeutic Strategy in Peripheral Neuropathic Pain: Intravenous Sodium Valproate Followed by Oral Route Treatment Versus Placebo (Clinical and Neurophysiologic Evaluation)
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Neuralgia
  • Neuropathic Peripheral Pain
Drug: Sodium Valproate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
July 2005
Not Provided

Inclusion Criteria:

  • peripheral neuropathic pain
  • signed written informed consent

Exclusion Criteria:

  • central neuropathic pain
  • current or past hepatic disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00221637
9236-01
2000-003
Yes
Not Provided
Not Provided
Not Provided
University Hospital, Bordeaux
Sanofi-Synthelabo
Principal Investigator: Virginie Dousset, Dr University Hospital, Bordeaux
Study Chair: Paul Perez, Dr University Hospital, Bordeaux
University Hospital, Bordeaux
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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