Efficacy of Valproate in Peripheral Neuropathic Pain

Neuralgia Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00221637
• Other study ID #: 9236-01
• Secondary ID: 2000-003
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: June 12, 2007
• Start date: March 2002
• Est. completion date: July 2005

Study information

• Verified date: June 2007
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• peripheral neuropathic pain

• signed written informed consent

Exclusion Criteria:

• central neuropathic pain

• current or past hepatic disease

Study Design

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Peripheral Pain

Intervention

Drug:
• Sodium Valproate

Locations

Country	Name	City	State
France	Unité de traitement de la douleur chronique, Hôpital Pellegrin, CHU de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Sanofi-Synthelabo

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of pain on a visual analog scale		after 4 weeks of treatment
Secondary	intensity of mechanic allodynia
Secondary	intensity of dynamic allodynia
Secondary	use of analgesics (rescue medication)
Secondary	thermal sensitive and nociceptive thresholds, RIII reflex