Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221637
Status:
TERMINATED
Last Update Posted:
2007-06-13
First Post:
2005-09-13
Brief Title:
Efficacy of Valproate in Peripheral Neuropathic Pain
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment and treatments beyond expiry date
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2000-003 | None | None | None |