Efficacy of Valproate in Peripheral Neuropathic Pain

• Sponsor: University Hospital, Bordeaux (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00221637
• Collaborator: Sanofi-Synthelabo (Industry)
• Enrollment: 40
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuralgia; Neuropathic Peripheral Pain	Drug: Sodium Valproate	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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)
• Study Start Date: Mar 1, 2002
• Actual Study Completion Date: Jul 1, 2005

Outcome Measures

Primary Outcome Measures

1. Intensity of pain on a visual analog scale [after 4 weeks of treatment]

Secondary Outcome Measures

1. intensity of mechanic allodynia []

2. intensity of dynamic allodynia []

3. use of analgesics (rescue medication) []

4. thermal sensitive and nociceptive thresholds, RIII reflex []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• peripheral neuropathic pain

• signed written informed consent

Exclusion Criteria:

• central neuropathic pain

• current or past hepatic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00221637
• Other Study ID Numbers: 9236-01; 2000-003
• First Posted: Sep 22, 2005
• Last Update Posted: Jun 13, 2007
• Last Verified: Jun 1, 2007

• Keywords provided by , ,: Neuralgia; Valproate; Anticonvulsant Drugs; Pain Measurement; Randomized Controlled Trials
• Additional relevant MeSH terms: Neuralgia; Valproic Acid

Study Results

No Results Posted as of Jun 13, 2007