- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00221637
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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-
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Bordeaux, France, 33076
- Unité de traitement de la douleur chronique, Hôpital Pellegrin, CHU de Bordeaux
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- peripheral neuropathic pain
- signed written informed consent
Exclusion Criteria:
- central neuropathic pain
- current or past hepatic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intensity of pain on a visual analog scale
Time Frame: after 4 weeks of treatment
|
after 4 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
intensity of mechanic allodynia
|
intensity of dynamic allodynia
|
use of analgesics (rescue medication)
|
thermal sensitive and nociceptive thresholds, RIII reflex
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Virginie Dousset, Dr, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
Other Study ID Numbers
- 9236-01
- 2000-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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